georgie18
6 días hace
ONCY...57...Out with my other 1/2...🥳...Will revisit on the Break/Hold of the 100ma...
georgie18
Member Level
Re: georgie18 post# 685352
Wednesday, June 11, 2025 11:25:38 AM
Post#
685426
of 685672
ONCY...5399...🥳...Off my .36 Alert...Took 1/2 off the table here...
georgie18
Member Level
Re: georgie18 post# 378
Wednesday, June 11, 2025 7:07:34 AM
Post#
379
of 380
ONCY...43...🥳... https://finviz.com/news/78089/oncolytics-biotech-names-new-ceo-to-accelerate-momentum-in-immunotherapy-programs
Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.
georgie18
Member Level
Re: georgie18 post# 684927
Tuesday, June 10, 2025 10:07:27 AM
Post#
685213
of 685352
ONCY...4625...🥳...Reversing here...Off my .36 Alert...
georgie18
Member Level
Re: None
Saturday, June 07, 2025 8:03:18 AM
Post#
376
of 377
ONCY...36...🥳... https://schrts.co/uwrcvSPY ...Bullish Doji Star Reversal Pattern on this Oversold Pincher Chart...
Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a US$20 million share purchase agreement (SPA) providing a flexible source of funding, enabling the Company to progress towards key clinical milestones. Under the terms of the SPA, the Company, at its sole discretion, controls the timing and amount of all sales of common stock and does not entail any warrant coverage or other classes of shares.
As of March 31, 2025, the Company reported $15.3 million in cash and cash equivalents, projecting a cash runway through key milestones and through the third quarter of 2025.
georgie18
7 días hace
ONCY...5399...🥳...Off my .36 Alert...Took 1/2 off the table here...
georgie18
Member Level
Re: georgie18 post# 378
Wednesday, June 11, 2025 7:07:34 AM
Post#
379
of 380
ONCY...43...🥳... https://finviz.com/news/78089/oncolytics-biotech-names-new-ceo-to-accelerate-momentum-in-immunotherapy-programs
Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.
georgie18
Member Level
Re: georgie18 post# 684927
Tuesday, June 10, 2025 10:07:27 AM
Post#
685213
of 685352
ONCY...4625...🥳...Reversing here...Off my .36 Alert...
georgie18
Member Level
Re: None
Saturday, June 07, 2025 8:03:18 AM
Post#
376
of 377
ONCY...36...🥳... https://schrts.co/uwrcvSPY ...Bullish Doji Star Reversal Pattern on this Oversold Pincher Chart...
Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a US$20 million share purchase agreement (SPA) providing a flexible source of funding, enabling the Company to progress towards key clinical milestones. Under the terms of the SPA, the Company, at its sole discretion, controls the timing and amount of all sales of common stock and does not entail any warrant coverage or other classes of shares.
As of March 31, 2025, the Company reported $15.3 million in cash and cash equivalents, projecting a cash runway through key milestones and through the third quarter of 2025.
Paulness
1 semana hace
NEWS -- Oncolytics Biotech® Names New CEO to Accelerate Momentum in Immunotherapy Programs
SAN DIEGO and CALGARY, AB, June 11, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors.
Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.
"Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics' Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors."
Mr. Kelly added, "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders."
Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies.
In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types.
As a material inducement to Mr. Kelly's appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company's then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly's long-term incentives with the creation of shareholder value.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics' belief that pelareorep's consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships; our belief that we will move pelareorep forward effectively and efficiently to a place where prospective partners will see potential value; our plans and strategies to advance pelareorep towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
Logo: https://mma.prnewswire.com/media/2408622/5364608/Oncolytics_Biotech_Inc_Logo.jpg
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-names-new-ceo-to-accelerate-momentum-in-immunotherapy-programs-302478848.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2025/11/c1701.html
Paulness
4 semanas hace
NEWS -- Oncolytics Biotech® to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities
Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responses
New analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumors
Pre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancerSAN DIEGO and CALGARY, AB, May 23, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation highlights pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC), offering new insights into how this immunotherapy stimulates multiple arms of the immune system and primes tumors for treatment.
"For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL clones in the blood. These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size. Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy."
Abstract Number: 2562
Title: Role of pelareorep in activating anti-tumor immunity in PDAC.
Presentation Type: Poster
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: June 2, 2025, 1:30 - 4:30 p.m. CT
A copy of the ASCO presentation will be available on the Media page of Oncolytics' website (LINK) following the conclusion of the meeting.
Highlights from the poster and abstract include:
Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24
Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor
The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses
Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq®) in first-line metastatic PDAC patients, showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rateAbout GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
Logo - https://mma.prnewswire.com/media/2695058/Oncolytics_Biotech_Inc_Logo.jpg
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-new-clinical-trial-data-at-asco-showing-pelareoreps-unique-immune-activation-capabilities-302464177.html
SOURCE Oncolytics Biotech® Inc.
Paulness
1 mes hace
NEWS -- Oncolytics Biotech Inc (ONCY) Q1 2025 Earnings Call Highlights
Cash and Cash Equivalents: $15.3 million as of March 31, 2025.
Net Cash Operating Activities: $6.5 million for the quarter, down from $7.5 million in the same period last year.
General and Administrative Expenses: $3 million for the first quarter, consistent with the prior year.
Research and Development Expenses: $4.1 million, down from $5.7 million in Q1 of 2024.
Net Loss: $6.7 million or $0.08 per basic and diluted share, compared to $6.9 million or $0.09 per share in Q1 of 2024.
Share Purchase Agreement: USD20 million agreement with Alumni Capital to extend financial runway.Release Date: May 14, 2025For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Oncolytics Biotech Inc (NASDAQ:ONCY) reported promising clinical data for pelareorep, showing a 33% objective response rate in relapsed anal carcinoma, including a complete response lasting over 15 months.
The company is actively enrolling patients in the GOBLET Cohort 5 study for metastatic pancreatic cancer, supported by a $5 million grant from the Pancreatic Cancer Action Network.
Pelareorep demonstrated a favorable safety profile across multiple studies, allowing for combination with various chemotherapies and checkpoint inhibitors.
The company has secured a USD20 million share purchase agreement with Alumni Capital, providing financial flexibility and extending the runway through key milestones.
Oncolytics Biotech Inc (NASDAQ:ONCY) is exploring multiple registrational opportunities for pelareorep in breast cancer, supported by positive data from two randomized Phase 2 studies showing significant clinical benefits.Negative Points
The company is still in the process of searching for a new CEO, which may impact strategic decision-making and leadership continuity.
Despite promising data, regulatory approval for pelareorep in anal carcinoma is not guaranteed and the commercial opportunity is smaller compared to other indications.
Research and development expenses decreased due to reduced manufacturing and clinical trial costs, which could indicate a slowdown in certain development activities.
The net loss for the quarter was $6.7 million, reflecting ongoing financial challenges despite a slight improvement from the previous year.
There have been no recent interactions with the FDA regarding the pancreatic cancer program, which could delay potential registrational pathways.Q & A Highlights
Q: Regarding the anticipated start of the registrational trial in HR positive HER2 negative metastatic breast cancer, what can you share about the potential trial design for the study? Will PFS be a primary endpoint? And have there been any recent interactions with the FDA regarding the pancreatic cancer program? A: Thomas Heineman, Chief Medical Officer, explained that the primary endpoint for the breast cancer study is anticipated to be progression-free survival. The FDA has been informed of the pancreatic cancer program, and while there have been no recent discussions, the FDA granted Fast Track approval in pancreatic cancer.
Q: Are there specific areas like regional rights or co-development opportunities being prioritized in business development activities? Are there plans to explore additional combination approaches with immune checkpoint inhibitors? A: Christophe Degois, VP of Business Development, stated that they are exploring both global and regional partnerships, particularly for breast and pancreatic cancer. Thomas Heineman added that they are exploring combinations with checkpoint inhibitors, especially in pancreatic cancer, where there is strong synergy.
Q: Could you discuss the rationale and potential registration paths for treating patients at different stages of the breast cancer journey? A: Thomas Heineman clarified that while they are not shifting focus to earlier stages, there are opportunities in treating patients who have failed antibody-drug conjugate therapy. This could further de-risk the program and stimulate interest from partners and investors.
Q: Can you describe the basic structure of the share purchase agreement with Alumni Capital and the flexibility it offers? A: Kirk Look, CFO, explained that the agreement provides access to capital at their discretion, with a minimum purchase notice set at $750,000. This structure helps reduce the cost of capital and supports strategic program advancements.
Q: Have you utilized the share purchase agreement since its announcement? A: Kirk Look confirmed that they have tapped into the agreement strategically to ensure it functions as intended.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
Paulness
1 mes hace
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss First Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Wednesday, May 14, 2025, at 4:30 p.m. ET
SAN DIEGO and CALGARY, AB, May 6, 2025 Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Wednesday, May 14, 2025, at 4:30 p.m. ET to discuss a corporate update and financial results for the first quarter of 2025.
Conference Call & Webcast
Date: Wednesday, May 14, 2025
Time: 4:30 p.m. ET
Dial In – North American Toll-Free: (888) 510-2154
Dial In – International: (437) 900-0527
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 28038
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 28038#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-first-quarter-financial-results-and-recent-operational-highlights-302446465.html
SOURCE Oncolytics Biotech® Inc.
Paulness
2 meses hace
NEWS -- Oncolytics Biotech® to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep's Tumor-Fighting Mechanism of Action
ASCO data expected to highlight how pelareorep activates immune responses in pancreatic cancer patients
Ongoing updates support potential of pelareorep combination therapies in one of the deadliest and hardest-to-treat cancers
SAN DIEGO and CALGARY, AB, April 24, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep's anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) - the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options.
"Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer."
Abstract Number: 2562
Title: Role of pelareorep in activating anti-tumor immunity in PDAC.
Presentation Type: Poster
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: June 2, 2025, 1:30 - 4:30 p.m. CT
Abstracts will be published on the ASCO website at 5:00 p.m. ET on May 22, 2025.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that there are multiple clinical and regulatory options for bringing pelareorep to patients; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-showcase-new-pancreatic-cancer-data-at-asco-highlighting-pelareoreps-tumor-fighting-mechanism-of-action-302437172.html
SOURCE Oncolytics Biotech® Inc.
Paulness
2 meses hace
NEWS -- Oncolytics Biotech® and Pelareorep Discussed During Recent H.C. Wainwright Key Opinion Leader Event on Oncolytic Immunotherapies in Breast and Pancreatic Cancers
SAN DIEGO and CALGARY, AB, April 10, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, was discussed by field-leading key opinion leaders (KOLs) during a recent event hosted by H.C. Wainwright.
Martine Piccart, M.D., Ph.D., an Honorary Professor of Oncology at the Université Libre de Bruxelles (ULB) and Scientific Director of Oncology at the Institut Jules Bordet, in Brussels, Belgium, offered a detailed overview of the HR+/HER2- metastatic breast cancer landscape and emphasized the need for new treatment innovations, such as pelareorep, that work to activate the immune system to recognize and kill cancer.
Alexander Eggermont, M.D., Ph.D., Professor of Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany, provided insights on the current standards for treating pancreatic ductal adenocarcinoma (PDAC), a cancer type known for its resistance to treatment, and the potential impacts that an immunotherapy such as pelareorep might have on the field.
A replay of the full conversation can be found by clicking here.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track Designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mailto://mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-and-pelareorep-discussed-during-recent-hc-wainwright-key-opinion-leader-event-on-oncolytic-immunotherapies-in-breast-and-pancreatic-cancers-302425541.html
SOURCE Oncolytics Biotech® Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2025/10/c0748.html
Paulness
4 meses hace
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Friday, March 7, 2025, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Feb. 25, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Friday, March 7, 2025, at 8:30 a.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2024.
Conference Call & Webcast
Date: Friday, March 7, 2025
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 510-2154
Dial In – International: (437) 900-0527
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 48422
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 48422#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-recent-operational-highlights-302384064.html
SOURCE Oncolytics Biotech® Inc.
Paulness
4 meses hace
NEWS -- Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Recent clinical data presentations in these two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, demonstrate the potential of pelareorep across very different tumor types
SAN DIEGO, CA and CALGARY, AB, February 18, 2025 – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep’s potential in hard-to-treat cancers. Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.
“We’re hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “With positive feedback from regulators in place, we’re advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep’s strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025.”
German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned
Approval to Fully Enroll the Cohort Secured: Germany’s Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review.
What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms.
Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year.ASCO GI 2025 Data Confirms Pelareorep’s Potential in Pancreatic and Anal Cancers
At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep’s potential in two challenging cancer types:
Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone.
Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications.
Why This Matters: These findings further de-risk pelareorep’s development and could pave the way for larger registration-enabling clinical trials in these indications.
Looking Ahead: More Catalysts in 2025
Oncolytics is entering a pivotal year with multiple upcoming milestones, including:
Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep’s mechanism of action.
Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers.“We’re seeing clinical validation across multiple studies,” added Pisano. “With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers.”
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts.
About GOBLET Cohort 5
The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it prepares for registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding Oncolytics’ belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance our pancreatic cancer study toward full enrollment; our focus on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025; our plans to continue to collect safety data; the anticipated timing of an initial efficacy readout; our belief that our new clinical results in anal and pancreatic cancer further de-risk pelareorep’s development and could pave the way for larger registration-enabling clinical trials in these indications; our upcoming milestones, including additional data readouts and interactions with regulatory agencies; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics’ business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
Paulness
4 meses hace
NEWS -- Oncolytics Biotech® Announces Matt Coffey, Ph.D. Will Not Return to CEO Role Following Medical Leave of Absence
Search for Chief Executive Officer to commence immediately
SAN DIEGO and CALGARY, AB, Feb. 7, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Matt Coffey, Ph.D., President and Chief Executive Officer, will not return following a medical leave of absence and ongoing health concerns. After much thought and consideration, Dr. Coffey reached a decision that in the best interest of his family and Oncolytics Biotech Inc., he would officially step down as CEO and Director of the company.
"While we are saddened by his departure, we fully understand, respect, and support his decision. For the past 25 years, Matt has been invaluable to the organization and has led the development of pelareorep from pre-clinical through successful Phase 2 studies for metastatic breast cancer and pancreatic cancer. First as a co-founder and most recently as CEO, he has left an indelible fingerprint on the company and its employees. On behalf of the Board of Directors and all the dedicated employees of Oncolytics, we wish Matt good health and success, both now and in the future," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We will now initiate a search for a Chief Executive Officer to lead the team as we work to bring Matt's vision of developing and making available a novel therapeutic agent (pelareorep) that addresses unmet needs in people undergoing cancer treatment." Wayne Pisano will remain Interim CEO until the new CEO is hired.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-matt-coffey-phd-will-not-return-to-ceo-role-following-medical-leave-of-absence-302371699.html
SOURCE Oncolytics Biotech® Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/February2025/07/c2799.html
Paulness
5 meses hace
NEWS -- Oncolytics Biotech® to Present Compelling New Efficacy and Safety Data in Anal and Pancreatic Cancers at 2025 ASCO GI Symposium
Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients
Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients
SAN DIEGO and CALGARY, AB, Jan. 22, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025.
Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, commented, "The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab. In pancreatic cancer, pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer. We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available."
"I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm."
Abstract Number: 6
Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab.
Presentation Type: Poster
Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT
The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design, and Stage 2 enrollment of 18 additional evaluable patients has begun. Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of 33%. This includes one patient with a prolonged complete response that persisted for over 15 months. This is notable because historical response rates to checkpoint inhibitor monotherapy are low, generally 10-24%1-3. There continue to be no safety concerns with the treatment regimen. At treatment cycle four, tumor-infiltrating lymphocyte (TIL) clonal expansion has been observed in the three responding patients for which data is available. It is anticipated that the additional data from Stage 2 of this cohort will provide a sufficiently strong efficacy signal to move this treatment regimen into a registration-enabling study.
Abstract Number: 730
Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab.
Presentation Type: Poster
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT
A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab. This cohort is being funded by a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN). The three-patient safety run-in for each treatment arm has completed enrollment, and patients have completed the necessary evaluation period. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification.
Abstracts from the ASCO Gastrointestinal Cancers Symposium are currently available on the event website, which can be accessed by clicking here.
References
Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: https://doi.org/10.1016/j.annonc.2020.08.2272.
Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.
Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452.About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to provide updates on the safety and efficacy of pelareorep-based combinations therapy; our expectation that additional data from the fourth cohort of our Stage 2 GOBLET study will provide a sufficiently strong efficacy signal to move the treatment regimen into a registration-enabling study; our plans to advance pelareorep to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mailto://mrubenstein@lifescicomms.com
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SOURCE Oncolytics Biotech® Inc.
Paulness
5 meses hace
NEWS -- Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data
New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1
SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.
Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.
"Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."
About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic PDAC patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab in 2nd line or later advanced and unresectable anal cancer patients; and
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
Paulness
6 meses hace
NEWS -- Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data
Promising BRACELET-1 results in HR+/HER2- metastatic breast cancer lay the foundation for potential registration-enabling study and accelerated approval
Advancing gastrointestinal cancer pipeline underscores potential for additional registration-enabling studies
SAN DIEGO and CALGARY, AB, Dec. 23, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, is providing a recap of the major accomplishments from 2024 and a preview of the milestones that are expected over the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across our clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.
"This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep's potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy - and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO GI Symposium - an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert 'cold' tumors to 'hot,' pelareorep's unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients' immune responses - making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey."
BRACELET-1's highly promising results lay a foundation for what we anticipate could be a pivotal, registration-enabling study, further aligning with our long-term goal of improving patient treatment options in metastatic breast cancer
In September, we reported final efficacy results from BRACELET-1, a randomized controlled study that showed marked clinical benefit in patients who received pelareorep-based combination therapy, reinforcing our confidence in pelareorep's ability to improve patient outcomes. These results included an estimated median overall survival benefit that exceeded one year and a two-year overall survival rate that was nearly double paclitaxel monotherapy (link to press release). Of note, the cohorts were well-balanced across key characteristics, including age, stage of disease, and prior lines of therapy, and pelareorep + paclitaxel demonstrated a favorable overall safety profile. BRACELET-1 also substantiates the results of our earlier IND-213 study, in which median overall survival in HR+/HER2- metastatic breast cancer patients was nearly doubled in patients treated with pelareorep + paclitaxel. Importantly, we also had a productive meeting with the FDA to present our breast cancer data and to align on key elements of our breast cancer program (link to the press release). This includes the use of progression-free survival as the primary endpoint in the planned registration-enabling study, which we believe will allow us to reach the final analysis within two years of the start of enrollment. If results from this registration-enabling study are similar to those observed in BRACELET-1, we believe they will provide a compelling basis for an accelerated approval application that could ultimately lead to making pelareorep available to approximately 55,000 patients in the US1-4 in need of better treatment options. We look forward to beginning enrollment into this study as soon as possible and providing more details as they become available.
Collaboration with GCAR on pancreatic cancer study
Our compelling data set in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) has provided us with opportunities to potentially help thousands of patients in this difficult-to-treat disease. We are excited to be working with the Global Coalition for Adaptive Research (GCAR) on a registration-enabling study for pelareorep in metastatic PDAC (link to press release). After more than doubling the objective response rate compared to historical control trials in cohort 1 of the GOBLET study, multiple key opinion leaders suggested we move the combination of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab directly into a study that could support regulatory approval. GCAR has a proven history of designing studies that could accelerate the registrational study timeline and provide substantial cost savings compared to traditional phase 3 trials. We continue to work together to finalize the master protocol and expect to engage with the FDA on our plans in the first half of 2025. Having already collaborated with Roche on GOBLET, we are excited Roche will participate in this registration-enabling study as well.
Progress on the PanCAN-supported pancreatic cancer cohort of GOBLET
Another exciting collaboration stemming from our pancreatic cancer data is with The Pancreatic Cancer Action Network (PanCAN). PanCAN provided the funding for a new GOBLET study cohort evaluating pelareorep + modified FOLFIRINOX (mFOLFIRINOX), with and without atezolizumab, in metastatic pancreatic cancer patients. We dosed the first patient in this cohort in June, completed safety run-in enrollment in Q4 of this year, and received favorable safety feedback from the Data Safety Monitoring Board (DSMB) earlier this month. This cohort represents an important opportunity to evaluate novel treatment options for this very difficult-to-manage disease and may form the basis for an additional pelareorep registrational path. As previously announced, we will be presenting data from this cohort at the ASCO GI Symposium in January 2025 (link to the press release).
Enrollment expansion in anal cancer provides another possible registrational study opportunity
Earlier this year, we expanded enrollment into cohort 4 of the GOBLET study, which is evaluating pelareorep and atezolizumab in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) (link to press release). We previously reported objective response rate data that roughly tripled historical control data and believe 18 patients of additional data could be sufficient to move to a registration-enabling study. While this is an uncommon cancer, the opportunity to improve treatment options would be profoundly impactful for patients and would serve as validation of pelareorep's potential, including its ability to synergize checkpoint inhibitors like atezolizumab. Additional efficacy data from this cohort will be reported at ASCO GI in January 2025.
Presentation at Biotech Showcase and hosting investor meetings during the 2025 J.P. Morgan Healthcare Conference
Finally, Oncolytics Biotech will be presenting at the Biotech Showcase at the Hilton San Francisco Union Square on January 13, 2025, at 2:30 p.m. PST, and the Executive Team will be meeting investors in addition to current and potential partners during the week of the J.P. Morgan Healthcare Conference (January 13-15, 2025).
Anticipated upcoming milestones
H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line PDAC with the GCAR and submit it to the FDA
H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer
H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer
H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed PDAC
H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancerReferences:
Gampenrieder, Simon Peter et al. "Landscape of HER2-low metastatic breast cancer (MBC): results from the Austrian AGMT_MBC-Registry." Breast cancer research : BCR vol. 23,1 112. 14 Dec. 2021, doi:10.1186/s13058-021-01492-x;
Schettini, Francesco et al. "Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer." NPJ breast cancer vol. 7,1 1. 4 Jan. 2021, doi:10.1038/s41523-020-00208-2
Mehta, Sandhya et al. "Prevalent of 'HER2 ultra-low' among patients with advanced breast cancer with historical IHC0 status." Journal of Clinical Oncology vol. 42, 16. 29 May 2024, doi.org/10.1200/JCO.2024.42.16_suppl.e1315;
Tarantino, Paolo et al. "HER2-Low Breast Cancer: Pathological and Clinical Landscape." Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 38,17 (2020): 1951-1962. doi:10.1200/JCO.19.02488About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic;our expectation that additional data readouts across our clinical development program in 2025 will help form what we believe is a clear pathway to future commercialization opportunities; our belief that pelareorep has the potential to become a transformational immunotherapy and that pelareorep-based combination therapies could accelerate our path toward regulatory approval; our plans to present our latest clinical progress early in the new year at the ASCO GI Symposium which we believe could provide key catalysts for our ongoing gastrointestinal cancer programs; our belief that the use of progression-free survival as the primary endpoint in the planned registration-enabling study will allow us to reach the final analysis within two years of the start of enrollment; our belief that if the results from our registration-enabling study in metastatic breast cancer are similar to those observed in BRACELET-1 they will provide a compelling basis for an accelerated approval application that could ultimately lead to making pelareorep available to approximately 55,000 patients in the U.S.; our expectation that we will engage with the FDA on our plans for our proposed study with GCAR in metastatic PDAC in the first half of 2025; our belief that our new GOBLET-study cohort represents an important opportunity to evaluate novel treatment options for this very difficult-to-manage disease and may form the basis for an additional pelareorep registrational path and our belief that 18 patients of additional data could be sufficient to move to a registration-enabling study; our anticipated upcoming milestones; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
Paulness
6 meses hace
NEWS -- Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium
SAN DIEGO and CALGARY, AB, Dec. 18, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025.
Tom Heineman, M.D., Ph.D., Oncolytics' Chief Medical Officer, said, "We are enthusiastic about pelareorep's applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer. Pelareorep engages patients' immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devastating diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients."
Abstract Number: 6
Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab.
Presentation Type: Poster
Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT
Abstract Number: 730
Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab.
Presentation Type: Poster
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT
Abstracts will be published on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that there are multiple clinical and regulatory options for bringing pelareorep to patients; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
Paulness
6 meses hace
NEWS -- Oncolytics Biotech® Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial's New Pancreatic Cancer Cohort
Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab
The study will begin with 30 patients, with an option to expand to an additional 34 participants
SAN DIEGO and CALGARY, AB, Dec. 3, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany's medical regulatory body. Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half.
The GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq®), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments.
"We see a promising opportunity for pelareorep to improve treatment options for PDAC patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The current standard of care is primarily chemotherapy, such as gemcitabine + nab-paclitaxel or mFOLFIRINOX. Pelareorep has already shown synergy with gemcitabine, nab-paclitaxel, and atezolizumab in GOBLET Cohort 1, and demonstrating efficacy with mFOLFIRINOX would further establish its potential to benefit PDAC patients. This study also builds on Cohort 1 by evaluating pelareorep's ability to work with checkpoint inhibitors, which would be a major advance, especially as immune therapies provide little benefit in most patients with this 'cold' tumor."
About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; continued enrollment in the GOBLET study and the expansion thereof to additional participants; approval from the Paul Ehrlich Institute; additional updates being provided in 2025, including safety data and initial efficacy results; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-completion-of-initial-safety-phase-enrollment-for-goblet-trials-new-pancreatic-cancer-cohort-302320744.html
SOURCE Oncolytics Biotech® Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2024/03/c8763.html
Paulness
7 meses hace
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Tuesday, November 12, 2024, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Nov. 11, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter 2024.
Conference Call & Webcast
Date: Tuesday, November 12, 2024
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 510-2154
Dial In – International: (437) 900-0527
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 68336
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 68336#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-recent-operational-highlights-302301016.html
SOURCE Oncolytics Biotech® Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2024/11/c3901.html
Paulness
8 meses hace
NEWS -- Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path
Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated approval
Key milestones in gastrointestinal cancer clinical trials expected in 2025, with potential for new registration-enabling studies
SAN DIEGO and CALGARY, AB, Oct. 4, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, is issuing a corporate update to provide investors with a deeper understanding of recent data and what is expected for 2025.
"We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic."
Mr. Pisano continued, "The gastrointestinal cancer data also supports making pancreatic cancer a major priority for the company. To advance this development, we've established a collaboration with the Global Coalition for Adaptive Research (GCAR), and The Pancreatic Cancer Action Network (PanCAN) has provided us with the funding to further investigate pelareorep in pancreatic cancer through our GOBLET study. Having demonstrated pelareorep's efficacy across multiple cancer indications and with important data readouts and future studies on the horizon, I'm looking forward to these next few years of Oncolytics' growth and development."
Planned HR+/HER2- metastatic breast cancer study could open the door to an accelerated approval
The strong efficacy results from BRACELET-1 provide the foundation for a large Phase 2 study designed to support an accelerated approval. Early in 2025, we plan to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on antibody-drug conjugates (ADCs) like Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs, which represents a patient population of approximately 55,000 patients in the US.1-4 The study design has sufficient statistical power to deliver a p-value of < 0.05 with a progression-free survival (PFS) benefit of =4.3 months. Notably, the BRACELET-1 study demonstrated a 5.7-month PFS benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone, as detailed below. Enrollment in the registration-enabling study is expected to commence in the first half of 2025.
Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, "With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field. Our first randomized study in breast cancer, IND-213, demonstrated the ability of pelareorep combination therapy to improve survival in heavily pre-treated patients with advanced or metastatic HR+/HER2- disease. The subsequent randomized BRACELET-1 study showed that pelareorep combination therapy could improve outcomes in HR+/HER2- breast cancer patients who had received prior CDK4/6 inhibitors. Based on the success of these studies, we are now ready to pursue a large phase 2 study powered to support an accelerated approval in the setting of ADC therapies such as Enhertu. Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways. Our thorough understanding of pelareorep's mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER2- breast cancer patients within the current treatment approach."
BRACELET-1 efficacy data in HR+/HER2- metastatic breast cancer
The recently reported final BRACELET-1 study results provide clear evidence of pelareorep's ability to improve outcomes in patients with advanced breast cancer (link to press release). Patients in the paclitaxel control arm had a median overall survival of 18.2 months. However, more than half of the patients in the pelareorep combination therapy arm were still alive at the time of the final survival analysis, resulting in a median overall survival of "Not Reached." A conservative estimate of median overall survival for the pelareorep arm is 32.1 months, demonstrating that pelareorep + paclitaxel delivered a greater than 12-month survival advantage compared to paclitaxel alone. This survival benefit is further illustrated by the 24-month overall survival rate, which showed that 64% of patients treated with pelareorep combination therapy survived at least 2 years compared to only 33% of patients treated with paclitaxel alone. In addition, final progression-free survival was 12.1 months for pelareorep + paclitaxel compared to 6.4 months for paclitaxel alone, yielding a benefit of 5.7 months.
Gastrointestinal cancer opportunities
We also anticipate continuing our development of pelareorep in gastrointestinal cancers. Once the master protocol has been finalized with GCAR for the pelareorep combination therapy, we intend to approach the FDA before the end of the year. This study is designed to produce registrational data. Additionally, we continue to evaluate pelareorep combination therapy in patients with anal cancer, building on the promising initial efficacy data in this patient population. If the expanded results continue to show a favorable efficacy signal, we anticipate moving directly to a registration-enabling study. Finally, we expect to provide updates on cohort 5 of the GOBLET study, which is investigating pelareorep in pancreatic cancer in combination with the chemotherapy modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab. Positive results from this combination will bolster our opportunity in pancreatic cancer and potentially provide an additional registrational opportunity. The initial efficacy results from this cohort are expected in the second half of 2025.
Anticipated upcoming milestones
H1 2025: Initiate registrational study of pelareorep + paclitaxel in HR+/HER2- metastatic breast cancerH1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancerH1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancerH2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancerReferences:
Gampenrieder, Simon Peter et al. "Landscape of HER2-low metastatic breast cancer (MBC): results from the Austrian AGMT_MBC-Registry." Breast cancer research : BCR vol. 23,1 112. 14 Dec. 2021, doi:10.1186/s13058-021-01492-x;Schettini, Francesco et al. "Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer." NPJ breast cancer vol. 7,1 1. 4 Jan. 2021, doi:10.1038/s41523-020-00208-2Mehta, Sandhya et al. "Prevalent of 'HER2 ultra-low' among patients with advanced breast cancer with historical IHC0 status." Journal of Clinical Oncology vol. 42, 16. 29 May 2024, doi.org/10.1200/JCO.2024.42.16_suppl.e1315;Tarantino, Paolo et al. "HER2-Low Breast Cancer: Pathological and Clinical Landscape." Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 38,17 (2020): 1951-1962. doi:10.1200/JCO.19.02488; DESTINY-BREAST04; DESTINY-BREAST06About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that our recent BRACELET-1 results provide the basis for a development path leading to an accelerated approval; our planned development approach for pelareorep; our belief that our gastrointestinal data supports making pancreatic cancer a major priority for Oncolytics; the design and objectives of our planned Phase 2 HR+/HER2- metastatic breast cancer study and the next steps related thereto and timing thereof; the design and objectives of our planned gastrointestinal study with GCAR and the next steps related thereto and timing thereof; our upcoming milestones and the anticipated timing thereof; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/2408622/Oncolytics_Biotech_Inc_Logo.jpg
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-key-progress-and-upcoming-studies-for-breast-and-pancreatic-cancer-treatments-prepares-for-fda-accelerated-approval-path-302267617.html
SOURCE Oncolytics Biotech® Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2024/04/c7780.html
Paulness
9 meses hace
NEWS -- Oncolytics Biotech® to Participate in Fireside Chats at Two Investment Conferences in September
SAN DIEGO and CALGARY, AB, Sept. 6, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Financial Officer Kirk Look will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference, which is taking place September 9-11, 2024 at the Lotte New York Palace Hotel in New York, NY. Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference, which is taking place September 17-19, 2024 at the InterContinental New York Barclay Hotel in New York, NY. Additional details on the fireside chats can be found below.
Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: Wednesday, September 11, 2024
Time: 9:00 a.m. ET
Location: Lotte New York Palace Hotel, Holmes I Room - 4th Floor
Webcast Link: Available by clicking here
Event: Cantor 2024 Global Healthcare Conference
Date: Thursday, September 19, 2024
Time: 10:55 a.m. ET
Location: InterContinental New York Barclay Hotel, Track 6 Morgan Suite
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conferences. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright or Cantor Fitzgerald representative, or email jpatton@oncolytics.ca.
Webcasts of the Company's presentations will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-fireside-chats-at-two-investment-conferences-in-september-302240554.html
SOURCE Oncolytics Biotech® Inc.
Paulness
11 meses hace
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 44th Annual Growth Conference
SAN DIEGO and CALGARY, AB, Aug. 2, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity's 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA. Additional details on the fireside chat can be found below.
Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Location: InterContinental Boston, Hutchinson Room
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-canaccord-genuitys-44th-annual-growth-conference-302213197.html
SOURCE Oncolytics Biotech® Inc.
Paulness
11 meses hace
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Thursday, August 1, 2024, at 4:30 p.m. ET
SAN DIEGO, Calif. and CALGARY, Alberta, July 24, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Thursday, August 1, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the second quarter 2024.
Conference Call & Webcast
Date: Thursday, August 1, 2024
Time: 4:30 p.m. ET
Dial In – North American Toll-Free: (800) 836-8184
Dial In – International: (646) 357-8785
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 34386
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 34386#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-recent-operational-highlights-302204603.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/July2024/24/c1327.html
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