FACT-MASTER
5 días hace
TCRX: TScan Therapeutics Announces $30 Million Registered Direct Offering at a 37% Premium
https://finance.yahoo.com/news/tscan-therapeutics-announces-30-million-120000459.html
TScan Therapeutics, Inc.
WALTHAM, Mass., Dec. 26, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that it has entered into a securities purchase agreement with Lynx1 Capital Management LP (Lynx1) and an investment fund advised by Lynx1 for the sale of approximately $30 million of pre-funded warrants to purchase up to an aggregate of 7,500,000 shares of its voting common stock at a price of $4.00 per pre-funded warrant, each exercisable to purchase one share of voting common stock at an exercise price of $0.0001 per share, representing a premium of 37% to the last closing price of TScan Therapeutics’ common stock, and a 34% premium over the 10-day volume weighted average closing price. The financing is expected to close on or about December 27, 2024, subject to customary closing conditions.
“Lynx1 has been a long-standing and supportive TScan shareholder. We are very appreciative of Lynx1’s continued support and commitment to our mission of delivering life-changing TCR-T cell therapies to patients with cancer, as evidenced by this additional and substantial investment in TScan at a 37% premium,” said Gavin MacBeath, Ph.D., Chief Executive Officer.
“We recently reaffirmed that our cash resources were expected to fund our operations into the fourth quarter of 2026. With the incremental $30M gross proceeds from the sale of these pre-funded warrants, we now expect our cash resources to fund the company’s operations into the first quarter of 2027,” said Jason A. Amello, Chief Financial Officer.
A registration statement on Form S-3 (File No. 333-268260) relating to these securities were filed with the Securities and Exchange Commission (the SEC) on November 9, 2022 and was declared effective by the SEC on May 16, 2023. A final prospectus supplement and accompanying prospectuses relating to the offering will be filed with the SEC. These documents will be available for free on the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-TTM Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.
FACT-MASTER
1 semana hace
TCRX: TScan Therapeutics Refinances Existing Convertible Debt Facility with Term Loan for up to $52.5 Million from Silicon Valley Bank
TScan Therapeutics, Inc.
New non-dilutive structure replaces existing convertible facility maturing in 2026, and extends loan maturity to 2029
WALTHAM, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that it has entered into a term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank, for up to $52.5 million. The first tranche of $32.5 million, advanced at loan closing, will be used to retire the existing convertible debt with K2 Health Ventures and the remainder for general corporate purposes.
TScan has the option through June 30, 2026, to draw the second $20.0 million tranche, subject to certain conditions and mutual agreement of TScan and SVB. Borrowings under the term loan facility will bear interest at an annual rate equal to the greater of 7.00%, or the prime rate minus 0.75%, subject to an interest rate cap of 9.75%. The term loans will mature on September 1, 2029, and will be subject to monthly interest-only payments until September 30, 2027, provided the Company achieves certain financial and clinical milestones, otherwise the term loans will mature on September 1, 2028, and the interest-only period will be through September 30, 2026.
“We’re pleased to enter into this non-dilutive agreement with SVB which allows us to significantly extend the interest-only period and maturity of our debt financing, providing TScan with added financial flexibility and liquidity,” said Jason A. Amello, Chief Financial Officer. “With this refinancing, we continue to expect our cash resources to fund our current operating plan into the fourth quarter of 2026. We’re looking forward to working with SVB as we deliver on our critical milestones, advance our mission to bring our potential therapies to patients with cancer, and enhance shareholder value.”
“We’re excited to partner with TScan as they advance their innovative hematology and solid tumor programs,” said Lauren Cole, Managing Director with SVB Life Science and Healthcare Practice. “Silicon Valley Bank is thrilled to provide TScan with this refinancing to support their ongoing development efforts to positively impact patients’ lives.”
Further information with respect to the loan agreement is set forth in a Form 8-K filed by TScan with the Securities and Exchange Commission on December 23, 2024.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-TTM Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.
About Silicon Valley Bank
Silicon Valley Bank (SVB), a division of First Citizens Bank, is the bank of some of the world’s most innovative companies and investors. SVB provides commercial banking to companies in the technology, life science and healthcare, private equity and venture capital industries. SVB operates in centers of innovation throughout the United States, serving the unique needs of its dynamic clients with deep sector expertise, insights and connections. SVB’s parent company, First Citizens BancShares, Inc. (NASDAQ: FCNCA ), is a top 20 U.S. financial institution with more than $200 billion in assets. First Citizens Bank, Member FDIC. Learn more at svb.com
FACT-MASTER
2 semanas hace
Pivotal Study Design.
Through a meeting with the FDA, the Company obtained feedback on the potential registrational pathway following the Phase 1 ALLOHA trial. Based on this feedback, the Company believes that for a registrational trial: (1) the following proposed patient population is acceptable: AML, MDS, and ALL undergoing allo-HCT with RIC, (2) relapse-free survival (RFS) will be an appropriate primary endpoint to support full approval and (3) use of an external control arm using data from Center for International Blood and Marrow Transplant Research (CIBMTR) will be acceptable to support full approval. The Company has decided to pursue an initial registrational path for TSC-101 as it captures almost all HLA-A*02:01-positive patients, and accordingly the Company believes that it is not necessary to include TSC-100 or a companion diagnostic in its upcoming trial. Subject to any further feedback from regulatory authorities or updates to streamline trial execution, the Company expects that the design of a potential registrational trial, which it anticipates launching in the second half of 2025, will include the following elements:
• Subjects: Patients with AML, MDS, ALL undergoing transplant with RIC.
• Donors: Haploidentical and mismatched unrelated donors.
• Enrollment: TSC-101 vs matched controls (1:3)
• Primary endpoint: Relapse-free survival
• Key secondary endpoint: Overall survival, time to relapse and event-free survival
• Exploratory endpoint: Minimal residual disease, complete chimerism rates
• Full approval: the study is designed with a HR of 0.60, 85% power and approximately 140 subjects in the treatment arm. The primary endpoint requires 184 total relapse and death events to assess efficacy
• Study readout: anticipated in approximately 24 months.
Next Steps.
The Company currently intends to focus on the following next steps for its heme malignancies program: (1) continue to enroll ALLOHA Phase 1 study using commercial manufacturing process at the Company, (2) transfer commercial process to a third-party contract development and manufacturing organization (CDMO), (3) work to reach final agreement with FDA on its pivotal trial design and (4) initiate registrational trial with clinical supply manufactured at CDMO.
FACT-MASTER
2 semanas hace
TCRX: From the recent 8k filing December 9/24
Solid Tumor Program.
TScan is building and expanding the ImmunoBank of T cell receptors (TCRs) to enable enhanced, multiplex TCR-engineered T cell (TCR-T) therapy, which is designed to address the heterogeneity of solid tumors:
• The solid tumor program will focus on immune-rich cancers with high unmet need, with T-Plex enrollment focusing on the following key indications: non-small cell lung cancer (NSCLC), sarcoma, head and neck cancer, and cervical cancer, and anal cancer.
• To date, eight patients have been infused with singleplex TCR-T.
• Early evidence of anti-tumor activity was observed.
• One TCR-T (TSC-203-A0201, which targets PRAME) has advanced through dose level 2 and is now eligible for T-Plex. A second TCR-T (TSC-200-A0201, which targets HPV16) is anticipated to clear dose level 2 before mid-December and will soon be eligible for T-Plex.
• TScan has successfully manufactured its first T-Plex product.
• TScan is progressing multiple TCRs through early does levels, which is expected to enable TScan to investigate multiplexed therapy in 2025.
• Investigational new drug filing for a TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) was submitted, which if cleared is expected to increase T-Plex eligibility.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1783328/000119312524273985/d917413d8k.htm
FACT-MASTER
3 semanas hace
Next Steps.
The Company currently intends to focus on the following next steps for its heme malignancies program: (1) continue to enroll ALLOHA Phase 1 study
using commercial manufacturing process at the Company, (2) transfer commercial process to a third-party contract development and manufacturing
organization (CDMO), (3) work to reach final agreement with FDA on its pivotal trial design and (4) initiate registrational trial with clinical supply manufactured at CDMO.
Market Opportunity.
The Company believes that if there is an increased use of reduced intensity conditioning with haploidentical donors and mismatched unrelated donors it
would have the potential to expand the addrssable market of its TCR-T therapy candidates, both in the United States and in Europe. The positive data
from the Company’s ALLOHA trial could potentially accelerate such changes in clinical practice and increase the total addressable market. The
Company believes that the addressable market can also be expanded with the introduction of additional TCR-Ts that target other HLA types. TCRs for
additional HLA types will target epitopes on CD45, a universal source of antigens for heme malignancies.
Solid Tumor Program.
TScan is building and expanding the ImmunoBank of T cell receptors (TCRs) to enable enhanced, multiplex TCR-engineered T cell (TCR-T) therapy,
which is designed to address the heterogeneity of solid tumors:
• The solid tumor program will focus on immune-rich cancers with high unmet need, with T-Plex enrollment focusing on the following key
indications: non-small cell lung cancer (NSCLC), sarcoma, head and neck cancer, and cervical cancer, and anal cancer.
• To date, eight patients have been infused with singleplex TCR-T.
• Early evidence of anti-tumor activity was observed.
• One TCR-T (TSC-203-A0201, which targets PRAME) has advanced through dose level 2 and is now eligible for T-Plex. A second TCR-T
(TSC-200-A0201, which targets HPV16) is anticipated to clear dose level 2 before mid-December and will soon be eligible for T-Plex.
• TScan has successfully manufactured its first T-Plex product.
• TScan is progressing multiple TCRs through early does levels, which is expected to enable TScan to investigate multiplexed therapy in
2025.
• Investigational new drug filing for a TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) was submitted, which if cleared is
expected to increase T-Plex eligibility.
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=318776541&type=PDF&symbol=TCRX&cdn=806d13b0878d47ad8d872c82514c5019&companyName=TScan+Therapeutics+Inc.&formType=8-K&formDescription=Current+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2024-12-10
FACT-MASTER
3 semanas hace
Pivotal Study Design.
Through a meeting with the FDA, the Company obtained feedback on the potential registrational pathway following the Phase 1 ALLOHA trial. Based
on this feedback, the Company believes that for a registrational trial: (1) the following proposed patient population is acceptable: AML, MDS, and ALL
undergoing allo-HCT with RIC, (2) relapse-free survival (RFS) will be an appropriate primary endpoint to support full approval and (3) use of an
external control arm using data from Center for International Blood and Marrow Transplant Research (CIBMTR) will be acceptable to support full
approval. The Company has decided to pursue an initial registrational path for TSC-101 as it captures almost all HLA-A*02:01-positive patients, and
accordingly the Company believes that it is not necessary to include TSC-100 or a companion diagnostic in its upcoming trial. Subject to any further
feedback from regulatory authorities or updates to streamline trial execution, the Company expects that the design of a potential registrational trial,
which it anticipates launching in the second half of 2025, will include the following elements:
• Subjects: Patients with AML, MDS, ALL undergoing transplant with RIC.
• Donors: Haploidentical and mismatched unrelated donors.
• Enrollment: TSC-101 vs matched controls (1:3)
• Primary endpoint: Relapse-free survival
• Key secondary endpoint: Overall survival, time to relapse and event-free survival
• Exploratory endpoint: Minimal residual disease, complete chimerism rates
• Full approval: the study is designed with a HR of 0.60, 85% power and approximately 140 subjects in the treatment arm. The primary
endpoint requires 184 total relapse and death events to assess efficacy
• Study readout: anticipated in approximately 24 months.
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=318776541&type=PDF&symbol=TCRX&cdn=806d13b0878d47ad8d872c82514c5019&companyName=TScan+Therapeutics+Inc.&formType=8-K&formDescription=Current+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2024-12-10
FACT-MASTER
3 semanas hace
TCRX: TScan Therapeutics to Present Updated Data from the Ongoing ALLOHA™ Phase 1 Heme Trial During Oral Session at the 66th American Society of Hematology Annual Meeting and Exposition
TScan Therapeutics, Inc.
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04), and treatment-arm patients trend towards lower probability of relapse (HR=0.28; p=0.14)
No dose-limiting toxicities observed and infusions of TSC-100 and TSC-101 were well-tolerated across all three dose levels
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, 2024, at 8:00 a.m. ET
WALTHAM, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that updated results from the ongoing ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. TSC-100 and TSC-101 are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning.
“Disease relapse is the leading cause of death in patients undergoing transplant following reduced intensity conditioning and represents a significant unmet medical need,” said Chrystal U. Louis, M.D., Chief Medical Officer. “As the majority of patients enrolled in both the treatment and control arms were considered at very high risk for relapse, we are highly encouraged by the preliminary ALLOHA study results, which suggest that TSC-100 and TSC-101 have the potential to eliminate residual disease and prevent relapse in patients with AML, ALL, or MDS post-HCT.”
“We are very excited by these data and, based on these results, we intend to launch a pivotal trial in the second half of 2025,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “Following recent feedback from the FDA, we believe we have a clear development path and will share our plans at our KOL event tomorrow morning.”
In the ongoing ALLOHA Phase 1 trial (NCT05473910), patients receive either TSC-100 or TSC-101 post-HCT, whereas control-arm patients receive HCT alone as per standard of care. To date, 38 patients have been enrolled in the trial and undergone HCT, with 26 in the treatment arm and 12 in the control arm. The key endpoints in the trial are safety and efficacy, with exploratory endpoints including donor chimerism and minimal residual disease (MRD) status.
Key Presentation Highlights:
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04) and early trends suggest a lower probability of relapse (HR=0.28; p=0.14).
2 of 26 (8%) treatment-arm patients relapsed compared to 4 of 12 (33%) control-arm patients. One treatment-arm relapse and subsequent mortality occurred in a very high-risk patient who was taken to transplant without first achieving complete remission, and the other was an extramedullary relapse in the patient’s central nervous system with no evidence of systemic relapse.
Median time to relapse was not evaluable in the treatment arm versus 160 days in the control arm.
8 of 38 (21%) patients in the study had TP53 mutations, with 6 cases in the treatment arm and 2 cases in the control arm. Of the 4 patients in the treatment arm with these mutations who received TCR-T cell infusions, none has relapsed, and one patient has now been relapse-free for 22 months. Of the 2 patients in the control arm with mutated TP53, both relapsed within 6 months of transplant and died shortly thereafter.
TSC-100 and TSC-101 infusions were well-tolerated at all three dose levels with no dose-limiting toxicities. Observed adverse events were similar across the treatment and control arms and were generally consistent with post-HCT adverse events.
TSC-100 and TSC-101 TCR-T cells were detected at all timepoints in all treated patients, including those who have been on study for over a year, with clear evidence of a dose-persistence relationship.
A copy of the presentation materials will be made available on the “Publications” section of the Company’s website at tscan.com once the presentation has concluded.
Virtual Key Opinion Leader (KOL) Event
The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, 2024, at 8:00 a.m. ET to discuss the data presented at ASH, updates with regards to a potential registrational path for the program following its initial meeting with the U.S. Food and Drug Administration, as well as future plans to expand the program, in addition to an update on the Company’s PLEXI-T™ Phase 1 solid tumor trial.
Dr. Reshef is the Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center. Details for attending the event can be found here.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-TTM Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.
https://finance.yahoo.com/news/tscan-therapeutics-present-updated-data-224500793.html
FACT-MASTER
4 semanas hace
How the RMAT Pathway is Accelerating Approval of Regenerative Therapies
https://ssistrategy.com/service-area/regulatory/how-the-rmat-pathway-is-accelerating-approval-of-regenerative-therapies/
To get new therapies for serious conditions faster to market, the U.S. Food and Drug Administration (FDA) offers a series of expedited programs. The Regenerative Medicine Advanced Therapy (RMAT) designation is for advanced therapies where preliminary clinical evidence indicates that the drug has a potential to address unmet medical needs for serious conditions.
There are several expedited development and review alternatives for novel therapies for serious conditions. The Regenerative Medicine Advanced Therapy (RMAT) designation is for advanced therapies where preliminary clinical evidence indicates the therapy has the potential to address the unmet medical need. RMAT designation makes innovative products eligible for quicker development and review of a marketing application.
What is RMAT?
In recognition of the growing importance of regenerative therapies, RMAT designation was enacted in the 21st Century Cures Act in December 2016, and the initiative aims to facilitate and expedite the development and review of regenerative medicines. During 2022 a total of 30 requests for RMAT were received by the FDA and 14 of them were granted.
The Regenerative Medicine Advanced Therapy (RMAT) designation is for advanced therapies intended to treat life-threatening conditions and preliminary clinical evidence indicates the therapy has the potential to address unmet medical need.
An investigational drug is eligible for RMAT designation if:
it meets the definition of regenerative medicine therapy i.e., cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. (See guidance for more detailed definition).
it is intended to treat, modify, reverse, or cure a serious condition; AND
preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition.
If RMAT designation is granted, the FDA will notify no later than 60 calendar days after submission. Failure to meet the qualifying criteria can also lead to the withdrawal of the RMAT designation.
Know what it takes
The RMAT designation offers important benefits to drug sponsors. Requests for RMAT designation can be made at the same time as the submission of the IND or later. Requests should be submitted to the FDA's Center for Biologics Evaluation and Research (CBER) in the IND or an amendment to the IND. As RMAT designation requires preliminary clinical evidence, many requests will be submitted as amendments. According to FDA guidance, the requests should be submitted no later than the end of phase 2. The request should contain:
A description of the product and the rationale for how it meets the definition of regenerative medicine therapy.
A discussion backing the severity of the disease or condition that the therapy intends to treat. The risks and benefits of any currently available therapies.
How the unmet medical needs are being addressed.
The preliminary clinical evidence supporting the designation.
When determining whether the preliminary clinical evidence is sufficient to support RMAT designation, CBER consider factors, including but not limited to: the rigor of data collection; the consistency and persuasiveness of the outcomes; the number of patients or subjects, and the number of sites, contributing to the data; and the severity, rarity, or prevalence of the condition.
The regulators expect the preliminary clinical evidence showing the potential of the therapy to address unmet medical needs to be obtained from clinical investigations. In early development, this evidence may not come from prospective clinical trials with a concurrent control. Data can be provided from clinical investigations with appropriate historical controls or well-designed retrospective studies. CBER will review the preliminary clinical evidence in each designation request and will make decisions on a case-by-case basis.
The benefits of RMAT
As regenerative therapies are right at the front line of medical innovation, the regulatory considerations may be addressed for the very first time, therefore there may be no best practice for what evidence is necessary to demonstrate safety while proving efficacy for each of these new therapies. Qualifying for RMAT designation conveys significant regulatory benefits and allows for potential regulatory challenges to be identified and addressed early in the development process.
Advantages of the RMAT designation include:
Activities to expedite development and review.
Rolling review
Intensive guidance on efficient drug development, beginning as early as Phase 1
Organizational commitment involving senior managers.
Early interactions with FDA
RMAT offers further accessibility to FDA guidance including early interactions to discuss surrogate or intermediate endpoints. By maintaining regular and timely interactions with the agency to receive their advice and feedback, drug development programs can be optimized for efficiency, resulting in faster access to safe medicines for patients. To effectively obtain valuable input from regulators, it is essential to communicate the narrative behind your data and ask well-defined and clear questions. Adhering to the advice provided by the agency will yield the best results.
Conclusion
RMAT's primary objective is to expedite the drug development and approval timeline, thereby enabling quicker access to new regenerative therapies. For drugs that show promise in treating a serious condition, the program offers closer collaboration with the Agency to provide more detailed feedback and a smoother track to the marketing application submission. By optimizing every regulatory interaction through clear and well-prepared communication, a more direct path to approval can be established.
FACT-MASTER
4 semanas hace
TCRX: TScan Therapeutics to Host Virtual KOL Event to Discuss Clinical Updates from the ALLOHA™ Phase 1 Trial and Heme Development Strategy
TScan Therapeutics, Inc.
Mon, December 2, 2024 at 6:00 AM CST 2 min read
In This Article:
TCRX
0.00%
TScan Therapeutics, Inc.
TScan Therapeutics, Inc.
Company to also provide an update on PLEXI-T™ Phase 1 solid tumor trial
WALTHAM, Mass., Dec. 02, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced the Company will host a virtual key opinion leader (KOL) event to discuss data from the ALLOHA™ Phase 1 heme trial presented at the ASH Annual Meeting and the clinical development strategy for the heme program. Additionally, the Company will provide an update on its PLEXI-T Phase 1 solid tumor trial. The virtual event will take place on Tuesday, December 10, at 8:00 a.m. ET.
The event will provide an in-depth review of the oral presentation describing the preliminary results from TScan’s ongoing ALLOHA Phase 1 heme trial of TSC-100 and TSC-101 in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning. The Company will also provide updates with regards to a potential registrational path for the program following its initial meeting with the U.S. Food and Drug Administration (FDA), as well as future plans to expand the program.
Featured speakers include:
Ran Reshef, M.D., M.Sc., Director of Translational Research, Blood and Marrow Transplantation Program, Columbia University Irving Medical Center
Gavin MacBeath, Ph.D., Chief Executive Officer, TScan Therapeutics
Chrystal U. Louis, M.D., Chief Medical Officer, TScan Therapeutics
Shrikanta Chattopadhyay, M.D., Senior Vice President, Head of Translational Medicine, TScan Therapeutics
Registration for the live event can be found here. A replay will be made available on the “Events and Presentations” section of the Company’s investor relations website at ir.tscan.com.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers and is enrolling patients into its ongoing PLEXI-T Phase 1 solid tumor trial.
Contacts
Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
hsavelle@tscan.com
Maghan Meyers
Argot Partners
212-600-1902
TScan@argotpartners.com
FACT-MASTER
2 meses hace
TCRX: TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
TScan Therapeutics, Inc.
Tue, November 12, 2024 at 6:00 AM CST 11 min read
In This Article:
TCRX
-1.38%
Upcoming oral presentation for the ALLOHATM Phase 1 heme trial at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10th at 8:00 a.m. ET to discuss clinical updates from the ALLOHA Phase 1 trial and heme development strategy
On track to dose first patient with multiplex TCR-T therapy and will provide an update on our Phase 1 study by the end of the year
Cash, cash equivalents, and marketable securities continue to fund operations into the fourth quarter of 2026
WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
“As we approach the end of the year, we remain committed to advancing our clinical-stage pipeline across both heme and solid tumor malignancies and providing an update on the ALLOHA Phase 1 trial following ASH. We are encouraged to see that none of the 16 patients on the treatment arm relapsed, including five patients at least one-year post-transplant as of the July 8th abstract cutoff date. We look forward to sharing updated data, including several additional patients, at ASH,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “During the third quarter we continued to prioritize screening, enrolling, and dosing patients in the solid tumor program and remain on track to dose our first patient with multiplex therapy and provide an update on our Phase 1 study by the end of the year.”
Recent Corporate Highlights
The Company recently announced an upcoming oral presentation at the 66th ASH Annual Meeting. The data in the abstract included 16 treatment-arm patients and 11 control-arm patients with a data cutoff of July 8, 2024. No dose limiting toxicities were observed across all treatment-arm patients and the safety profile was generally consistent with hematopoietic cell transplantation (HCT). All treatment-arm patients (16 of 16) were relapse-free and minimal residual disease (MRD)-negative as of the data cutoff, whereas three control-arm patients (3 of 11) relapsed, two of whom died from their disease. These data support both the safety and potential of TSC-100 and TSC-101 to reduce relapses and increase relapse-free survival in patients receiving reduced intensity conditioning HCT. Updated data will be presented at the annual meeting.
The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10th, at 8:00 a.m. ET to discuss the data presented at the ASH Annual Meeting. The Company will also discuss its clinical development strategy for the heme program. Dr. Reshef is the Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center. Additional details around the call will be provided closer to the event. Registration for the event can be found here.
The Company recently increased its internal manufacturing capacity as well as identified a global contract development and manufacturing organization (CDMO) with commercial capabilities to support both the heme and solid tumor programs. The Company is on track to transfer the commercial heme manufacturing process to the CDMO in 2025.
The Company recently presented three posters at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting held in Houston, TX and virtually:
Discovery of a MAGE-A4-specific TCR-T Therapy Candidate for Multiplex Treatment of Solid Tumors
Preclinical Models for T-Plex, a Customized Multiplexed TCR-T Cell Therapy Addressing Intra-Tumor Antigen and HLA Heterogeneity
Development of a Target Agnostic Platform to Assess the Reactivity of T Cell Receptor (TCR)-Engineered T Cell (TCR-T) Therapies to Primary Human Tissues
Copies of the presentation materials can be found under the “Publications” section of the Company’s website at tscan.com.
Upcoming Anticipated Milestones
Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) undergoing allogeneic HCT (the ALLOHATM trial, NCT05473910).
Plans to open expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints by the end of 2024.
One-year clinical and translational data on initial patients to be reported by the end of 2024.
Initiate a registration trial, pending feedback from regulatory authorities, and plans to report two-year clinical and translational data in 2025.
Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of therapeutic TCR-Ts that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-Ts to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027; treatment protocol: NCT05973487).
Actively screening, enrolling, and dosing patients across the TCR-T therapy candidates.
Update on solid tumor program expected by the end of 2024.
Investigational new drug (IND) filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) planned by the end of the year.
Response data for multiplex therapy anticipated in 2025.
Third Quarter 2024 Financial Results
Revenue: Revenue for the third quarter of 2024 was $1.0 million, compared to $3.9 million for the third quarter of 2023. The decrease was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen which commenced in May 2023.
R&D Expenses: Research and development expenses for the third quarter of 2024 were $26.3 million, compared to $22.7 million for the third quarter of 2023. The increase of $3.5 million was primarily driven by an increase in clinical studies expense associated with the ongoing enrollment of our ALLOHA Phase 1 heme trial and start-up activities and initial enrollment in our Phase 1 solid tumor clinical trial, as well as an increase in personnel expenses due to additional headcount in support of our expanded research and development activities. Research and development expenses included non-cash stock compensation expense of $1.2 million and $0.9 million for the third quarter of 2024 and 2023, respectively.
G&A Expenses: General and administrative expenses for the third quarter of 2024 were $7.4 million, compared to $5.9 million for the third quarter of 2023. The increase of $1.5 million was primarily driven by an increase in personnel expenses due to increased headcount to support business activities. General and administrative expenses included non-cash stock compensation expense of $1.3 million and $0.4 million for the third quarter of 2024 and 2023, respectively.
Net Loss: Net loss was $29.9 million for the third quarter of 2024, compared to $23.0 million for the third quarter of 2023, and included net interest income of $2.7 million and $1.8 million, respectively.
Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2024, were $271.1 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will continue to fund its current operating plan into the fourth quarter of 2026.
Share Count: As of September 30, 2024, the Company had issued and outstanding shares of 53,354,124, which consists of 49,077,536 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 65,587,945 shares of voting common stock at an exercise price of $0.0001 per share.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company is also developing TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers.
https://finance.yahoo.com/news/tscan-therapeutics-reports-third-quarter-120000511.html
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