FACT-MASTER
2 semanas 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
FACT-MASTER
3 semanas hace
TCRX: Article of interest -Nov. 7/24
https://finance.yahoo.com/news/tscan-therapeutics-tcrx-soars-7-094300011.html
TScan Therapeutics, Inc. (TCRX) shares soared 7.6% in the last trading session to close at $5.69. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 5.4% loss over the past four weeks.
The company is developing its lead TCR-T therapy candidates, TSC-100 and TSC-101, in an early-stage study for treating patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation. TScan is also developing TCR-T therapy candidates for treating various solid tumors. The growing optimism about the company’s pipeline candidates might have driven the recent share price rally.
This company is expected to post quarterly loss of $0.28 per share in its upcoming report, which represents a year-over-year change of -16.7%. Revenues are expected to be $2.86 million, down 26.4% from the year-ago quarter.
Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements.
For TScan Therapeutics, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. And a stock's price usually doesn't keep moving higher in the absence of any trend in earnings estimate revisions. So, make sure to keep an eye on TCRX going forward to see if this recent jump can turn into more strength down the road.
The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
TScan Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry. scPharmaceuticals, Inc. (SCPH), another stock in the same industry, closed the last trading session 6.6% higher at $4.34. SCPH has returned 2.4% in the past month.
For scPharmaceuticals , the consensus EPS estimate for the upcoming report has remained unchanged over the past month at -$0.30. This represents a change of +26.8% from what the company reported a year ago. scPharmaceuticals currently has a Zacks Rank of #3 (Hold).
FACT-MASTER
3 semanas hace
TCRX: TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition
n This Article:
TCRX
+5.12%
All TSC-treated patients were relapse-free and MRD negative as of data cutoff
TSC-100 and TSC-101 demonstrate the potential to reduce relapse rates and increase relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT with reduced intensity conditioning
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, at 8:00 a.m. ET
WALTHAM, Mass., Nov. 05, 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 preliminary results from the ALLOHA™ Phase 1 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, will be featured in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 7 – 10 in San Diego, CA. A copy of the abstract is now available online via the ASH website at www.hematology.org.
“Disease relapse is the leading cause of death in patients undergoing transplant with reduced intensity conditioning,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “TSC-100 and TSC-101 were designed with this significant unmet need in mind, and preliminary clinical and translational data from the ALLOHA trial supports the safety and potential of TSC-100 and TSC-101 to reduce relapses and increase relapse-free survival. We look forward to providing additional data from the ongoing trial at the meeting in December.”
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. As of the July 8, 2024 data cut, 27 patients were enrolled in the trial and had undergone HCT, with 16 in the treatment arm and 11 in the control arm. No relapses occurred in the treatment arm versus three relapses in the control arm. Median time to relapse was not evaluable in TSC-treated patients, where no relapses occurred, versus 159 days in the control arm. All five TSC-treated patients that reached one-year follow-up remained relapse-free and MRD negative as of the data cutoff, consistent with effective elimination of residual cancer cells post-HCT. No dose limiting toxicities occurred following TSC-100 or TSC-101 infusions and safety was similar in the treatment and control arms, with expected post-HCT adverse events.
Enrollment in the ALLOHA Phase 1 trial continues and updated data will be presented at the meeting in December.
Oral Presentation Details:
Title: TSC-100 and TSC-101 Demonstrate the Potential to Reduce Relapse Rates and Increase Relapse-Free Survival in Patients with AML, ALL, or MDS Undergoing Allogeneic HCT with Reduced Intensity Conditioning (RIC): Preliminary Results from the Phase 1 ALLOHA Trial
Authors: Monzr M Al Malki, Alla Keyzner, Uday Popat, Yi-Bin Chen, Hyung C Suh, Tania Jain, Melhem M Solh, Anson Snow, Saar Gill, Lohith Gowda, Joseph Uberti, Erica Buonomo, Yun Wang, Nancy Nabilsi, Timothy White, Cuong Nguyen, Jim Murray, Gavin MacBeath, Chrystal Louis, Shrikanta Chattopadhyay, Michelle Matzko, Ran Reshef
Publication Number: 924
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging Targeting Approaches of Cell Therapies for Hematologic Malignancies
Session Date & Time: Monday, December 9, 2024; 2:45 - 4:15 p.m. Pacific Time
Presentation Time: 4:00 p.m. Pacific Time
Location: San Diego Convention Center, Hall B
A copy of the presentation materials will be added to 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. 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, 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.
FACT-MASTER
4 semanas hace
TCRX: Renting additional square footage beginning in the 4th quarter/24
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001783328/000119312524249124/d891090d8k.htm
Item?1.01
Entry into a Material Definitive Agreement
Effective October 28, 2024, TScan Therapeutics, Inc. (the “Company”) entered into a second amendment (the “Second Amendment”) to its existing lease with PPF OFF 828-830 Winter Street LLC (the “Landlord”), dated August 13, 2019, as amended by the first amendment thereto dated November 8, 2023 (as amended the “Existing Lease”), with respect to 25,472 rentable square feet of space (the “Existing Premises”) in certain premises located at 830 Winter Street, Waltham, Massachusetts.
Under the terms of the Second Amendment, the Company has agreed to lease approximately an additional 25,628 rentable square feet of space (the “Expansion Premises”) in the premises located at 830 Winter Street, Waltham, Massachusetts to support its operations, for a term commencing in the fourth quarter 2024 to October 31, 2029, subject to any permitted renewal pursuant to the Existing Lease. The Company will be obligated to pay the Landlord an additional base rent for the Expansion Premises at the monthly rate of $163,378.50, commencing two months after the start of the term for the Expansion Premises, for the first 12-month period, $168,279.86 for the second 12-month period, $173,328.25 for the third 12-month period, $178,528.10 for the fourth 12-month period, and $183,883.94 for the final 12-month period, which may be prorated for any partial year, in addition to the base rent for the Existing Premises as set forth in the Existing Lease.
Under the terms of the Second Amendment, the Landlord has agreed to provide to the Company a tenant improvement allowance of up to approximately $2,681,540.
The forgoing summary of the material terms of the Second Amendment is qualified in its entirety by reference to the complete text of the Second Amendment, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
FACT-MASTER
3 meses hace
TCRX: TScan Therapeutics to Participate in Upcoming Investor Conferences
TScan Therapeutics, Inc.
WALTHAM, Mass., Aug. 29, 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 the Company will participate in the following upcoming investor conferences:
Morgan Stanley 22nd Annual Global Healthcare Conference; the fireside chat will be held at the New York Marriott Marquis on Thursday, September 5, 2024 at 8:30 a.m. ET
H.C. Wainwright 26th Annual Global Investment Conference; the presentation will be held at the Lotte New York Palace Hotel on Tuesday, September 10, 2024 at 9:00 a.m. ET
Webcasts of the fireside chat and presentation will be available on the “Events and Presentations” section of the Company’s website at ir.tscan.com. An archived replay of the webcasts will be available on the Company’s website for 90 days following the events.
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 ALLOHA 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.
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
6 meses hace
TCRX: TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies
https://finance.yahoo.com/news/tscan-therapeutics-receives-fda-regenerative-110000336.html
TScan Therapeutics, Inc.
RMAT designation granted for both TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning
WALTHAM, Mass, May 29, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical 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 the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company’s two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910).
“We are delighted to receive FDA RMAT designation for both candidates in our heme program designed to treat patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning, based on encouraging initial data from the ALLOHA trial,” said Chrystal U. Louis, M.D., Chief Medical Officer. “This is an important milestone that recognizes the transformative potential of our engineered TCR-T therapy candidates, TSC-100 and TSC-101, in multiple difficult-to-treat cancers. We look forward to working closely with the FDA in our ongoing commitment to deliver life-changing therapies to patients.”
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including gene and cell therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such a disease or condition. Like Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of an Investigational New Drug (IND) application, and other opportunities to expedite development and review.
TScan has developed two lead TCR-T therapy candidates, TSC-100 and TSC-101, that target minor histocompatibility antigens HA-1 and HA-2, respectively. TScan is prospectively selecting HLA A*02:01-positive transplant patients who are either HA-1- or HA-2-positive, with donors who are negative for these antigens. In this context, TSC-100 and TSC-101 are designed to eliminate all recipient hematopoietic cells, including malignant, pre-malignant or normal cells, that persist post-transplant, while leaving donor-derived cells unaffected. Approximately 40% of patients with AML, ALL, and MDS who undergo allogeneic haploidentical HCT with reduced intensity conditioning relapse within two years of transplant, at which point there are limited treatment options and poor prognosis. The goal of this program is to increase the cure-rate for patients receiving HCT.
On May 13, 2024, the Company provided an update on its Phase 1 heme malignancies program. The update included additional follow-up on all eight treatment-arm patients as well as data on two additional control-arm patients. With a median follow-up of >10 months, all eight patients treated with TSC-100 or TSC-101 remain relapse-free with no detectable disease. No dose-limiting toxicities were observed. In contrast, two of eight control-arm patients relapsed approximately six months post-transplant and one of these patients died approximately three months later. A third control-arm patient required clinical intervention because of concerns of impending relapse, and a fourth control-arm patient died post-transplant.
FACT-MASTER
6 meses hace
Interesting FDA approval for Amgen today - Bispecific T-cell Engager
https://finance.yahoo.com/news/fda-approves-imdelltra-tarlatamab-dlle-224500427.html
Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor
IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study
Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT
THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9246451-fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer/
"The FDA's approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE®) molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."
"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years," said David P. Carbone, M.D., Ph.D., professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center.1 "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."
IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's own T cells to attack DLL3-expressing tumor cells.2
"After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available," said Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer. "Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease."
The FDA accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Results from the study found that IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.3
The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The most common (> 20%) adverse reactions reported among patients were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%), and nausea (22%). Permanent discontinuations due to treatment-emergent adverse events (TEAEs) were infrequent (7%). CRS was largely confined to the first and second dose, predominantly grade 1 or 2, and was generally managed with supportive care. Details of the Important Safety Information are included below.
Amgen's Commitment to Patient Support
Amgen is committed to supporting patients with ES-SCLC and to helping ensure appropriate patients with access to IMDELLTRA. Patients, caregivers, and physicians who need support, tools, or resources can contact Amgen® SupportPlus. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including for uninsured or under-insured patients through the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.
Amgen to Webcast Investor Call on IMDELLTRA FDA Approval
Amgen will host a webcast call for the investment community on Monday, May 20, 2024 at 1:00 p.m. PT (4:00 p.m. ET). Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen, Murdo Gordon, executive vice president of Global Commercial Operations, and other members of the Amgen team will participate.
Live audio of the investor call will be simultaneously broadcast over the internet and will be available to members of the news media, investors, and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability, and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About IMDELLTRA™ (tarlatamab-dlle)
IIMDELLTRA is a first-in-class immunotherapy engineered by Amgen researchers that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.2,4 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.3,5
IMDELLTRA™ (tarlatamab-dlle) U.S. Indication
IMDELLTRA™ (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
FACT-MASTER
7 meses hace
TCRX: TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors
https://finance.yahoo.com/news/tscan-therapeutics-announces-first-patient-110000594.html
TScan Therapeutics, Inc.
Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME
On-track to report initial data from the solid tumor clinical trial in 2024
WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical 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 the first patient has been dosed in the Company’s Phase 1 trial evaluating TCR-T therapy for the treatment of solid tumors. The patient, diagnosed with metastatic melanoma, was dosed with TSC-203-A0201 targeting the cancer-associated antigen PReferentially expressed Antigen in MElanoma (PRAME).
“Dosing the first patient in our solid tumor program is a significant milestone for us, as we are now well underway with both of our core clinical programs,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “There is a lot of enthusiasm for this trial, and we are already manufacturing TCR-T products for three more patients. We have six TCR-Ts cleared under existing IND applications for patient dosing in this program, and we plan to file additional IND applications to further expand the ImmunoBank across diverse targets and HLA types to broaden the reach of multiplex TCR-T therapy for solid tumors.”
“Solid tumors are notoriously heterogeneous, and we believe that an effective way to treat solid tumors is through a multi-pronged approach,” added Chrystal U. Louis, M.D., Chief Medical Officer. “Customized multiplex TCR-T therapy is designed to achieve durable responses by overcoming tumor heterogeneity and resistance that develops from either target or HLA loss. We look forward to sharing initial data from our solid tumor trial later this year.”
About TScan’s Solid Tumor Program
TScan’s Phase 1 clinical trial is designed to assess the safety and feasibility of T-Plex, autologous customized TCR-T therapy targeting multiple peptide/human leukocyte antigens (HLA) targets in participants with antigen-positive, locally advanced, unresectable or metastatic solid tumors. Multiplex TCR-T therapy has the potential to overcome tumor heterogeneity and HLA loss of heterozygosity, commonly observed resistance mechanisms in solid tumors. First generation TCR-T therapies, targeting single antigens, have shown encouraging response rates in patients, but have often shown limited duration of response.
TScan believes that its approach of dosing patients with more than one TCR-T targeting different cancer-associated antigens will result in increased response rates and increased duration of response. To make this possible, TScan is screening patients (screening protocol: NCT05812027) with melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, cervical cancer, ovarian cancer, anogenital cancers, and other solid tumors for target expression and the presence of intact HLA genes in their tumor cells. Eligible patients are then enrolled in the study treatment protocol (NCT05973487) and administered one or more investigational TCR-T products that are matched to cancer-associated antigens expressed in their tumors. This is made possible by the Company’s ImmunoBank, its repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types. Currently, the ImmunoBank includes six TCR-T clinical candidates in Phase 1 development: TSC-203-A0201 (PRAME, HLA-A*02:01); TSC-200-A0201 (HPV16, HLA-A*02:01); TSC-201-B0702 (MAGE-C2, HLA-B*07:02); TSC-204-A0201 (MAGE-A1, HLA-A*02:01); TSC-204-C0702 (MAGE-A1, HLA-C*07:02); and TSC-204-A0101 (MAGE-A1, HLA-A*01:01). TScan intends to continue to expand the ImmunoBank with TCR-Ts for additional targets and HLA types, thereby increasing the number of patients that are eligible to receive multiplex therapy.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The Company’s lead TCR-T 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 Company is also developing multiplexed TCR-T 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 therapeutic TCR-Ts for patients with a variety of cancers.
FACT-MASTER
7 meses hace
TCRX: TScan Therapeutics Announces Upcoming Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting
https://finance.yahoo.com/news/tscan-therapeutics-announces-upcoming-presentations-210100850.html
TScan Therapeutics, Inc.
WALTHAM, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the acceptance of one abstract for oral presentation and four abstracts for poster presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11 in Baltimore, MD as well as virtually.
Oral Presentation Details:
Title: Discovery of Tumor Reactive TCRs and Their Cognate Antigenic Targets via High-Throughput Functional Screening
Presenter: Candace Perullo
Abstract Number: 419
Session Title: Targeted Gene and Cell Therapy II
Session Date/Time: Saturday, May 11; 10:15 a.m. - 12:00 p.m. Eastern Time
Presentation Time: 11:15 - 11:30 a.m. Eastern Time
Location: Room 318-323
Poster Presentation Details:
Title: Nonclinical Development of T-Plex Component TSC-204-A0101: A Natural TCR-T Cell Therapy for the Treatment of MAGE-A1- and HLA-A*01:01-Positive Cancers
Presenter: Shazad Khokhar, Ph.D.
Abstract Number: 834
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall
Title: Non-Clinical Development of T-Plex Component TSC-201-B0702: A TCR-T Cell Therapy Directed to a Novel HLA-B*07:02 Restricted MAGE-C2 Epitope for the Treatment of Solid Tumors
Presenter: Hannah Bader, Ph.D.
Abstract Number: 835
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall
Title: Trial in Progress: A Phase 1, First in Human Clinical Trial for T-Plex, a Multiplexed, Enhanced T Cell Receptor-Engineered T Cell Therapy (TCR-T) for Solid Tumors
Presenter: Dawn Pinchasik, M.D.
Abstract Number: 1900
Session Title: Friday Posters: Cell Therapy and Cell-Based Gene Therapy Trials
Session Date/Time: Friday, May 10; 12:00 p.m. Eastern Time
Location: Exhibit Hall
Title: Trial in Progress: A Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Eliminate Residual Disease After Hematopoietic Cell Transplantation
Presenter: Michelle Matzko, M.D., Ph.D.
Abstract Number: 1901
Session Title: Friday Posters: Cell Therapy and Cell-Based Gene Therapy Trials
Session Date/Time: Friday, May 10; 12:00 p.m. Eastern Time
Location: Exhibit Hall
A copy of the presentation materials will be added to the “Publications” section of the Company’s website at tscan.com once presentations have concluded.
FACT-MASTER
7 meses hace
TCRX: TScan Therapeutics Announces Closing of Upsized Public Offering
https://www.biospace.com/article/releases/tscan-therapeutics-announces-closing-of-upsized-public-offering/
Published: Apr 19, 2024
WALTHAM, Mass., April 19, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the closing of an underwritten public offering of 2,472,581 shares of its voting common stock at a public offering price of $7.1300 per share, which was equal to the closing price of its voting common stock on the Nasdaq Global Market on April 16, 2024, and pre-funded warrants to purchase up to an aggregate of 18,577,419 shares of its voting common stock at a price to the public of $7.1299 per pre-funded warrant to purchase one share of the voting common stock, which represents the per share public offering price for the voting common stock less the $0.0001 per share exercise price for each such pre-funded warrant. In addition, TScan has granted the underwriters a 30-day option to purchase up to an additional 3,157,500 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan.
Morgan Stanley and TD Cowen acted as joint book-running managers for the offering. LifeSci Capital acted as lead manager, and BTIG, H.C. Wainwright & Co. and Needham & Company acted as co-managers for the offering.
The Company intends to use the net proceeds from the offering for general corporate purposes. Following this offering, and excluding any additional proceeds from the underwriters’ exercise of their over-allotment option, the Company expects its cash, cash equivalents and marketable securities will fund its current operating plan into the fourth quarter of 2026.
A registration statement on Form S-3 (File No. 333-277699) relating to these securities was filed with the Securities and Exchange Commission (the SEC) on March 6, 2024, and was declared effective by the SEC on April 12, 2024. The offering was made only by means of a preliminary prospectus supplement and accompanying filed with the SEC. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC. These documents are available for free on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, telephone: (866) 718-1649 or by emailing prospectus@morganstanley.com, or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities.com.
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.
FACT-MASTER
7 meses hace
TCRX: TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities - April 16/24
https://finance.yahoo.com/news/tscan-therapeutics-provides-clinical-pipeline-200100396.html
TScan Therapeutics, Inc.
Over 40 solid tumor patients have completed all biomarker testing in the screening protocol; ~60% of these patients qualify for at least one TCR-T in the ImmunoBank and ~30% are eligible for multiplex therapy
Patients identified across all six TCR-T cohorts in solid tumor program with dosing of first three expected in early May
All eight patients in the heme program treated with TSC-100 or TSC-101 remain relapse-free with no detectable cancer to date; median follow-up of >10 months
WALTHAM, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today provided an update on its solid tumor and heme malignancies clinical programs.
“We continue to make meaningful progress across both our solid tumor and heme malignancies Phase 1 clinical programs. As we rapidly approach dosing the first patients in the solid tumor program, I am pleased to share that over 40 patients have completed all biomarker testing in the screening protocol, with the majority qualifying for at least one TCR-T in our ImmunoBank and many qualifying for multiplex therapy. This should allow for rapid enrollment into the treatment protocol over the course of the year,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “With respect to the heme program, we are encouraged to see continued positive data with all treatment-arm patients remaining relapse-free with no detectable cancer to date, now with a median follow-up of over 10 months.”
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).
Phase 1 solid tumor clinical study has been initiated; first three patients expected to be dosed in early May 2024.
More than 40 patients have completed all biomarker testing in the screening protocol across a broad array of tumor types. 60% of patients qualify for at least one TCR-T in the ImmunoBank and approximately 30% are eligible for multiplex therapy (T-Plex), potentially enabling rapid enrollment into the treatment protocol upon disease progression.
Patients have been identified across all six TCR-T cohorts with dosing expected to commence early May.
Initial data on patients from both singleplex and multiplex cohorts expected in the second half of 2024.
Additional IND filings planned to continue to expand the ImmunoBank.
Long-term duration of response data for multiplex therapy anticipated in 2025.
Heme Malignancies Program: TScan’s two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) (NCT05473910).
All eight patients treated with TSC-100 or TSC-101 remain MRD negative, relapse-free with no detectable cancer to date in either bone marrow biopsies or peripheral blood (median follow-up of >10 months) and no dose limiting toxicities observed to date.
To date, all but one patient has exhibited complete donor chimerism in all subsets of blood cells at all time-points, indicating that only donor-derived cells are present in these patients following treatment with either TSC-100 or TSC-101. One patient with T-ALL who was treated with TSC-100 at the lowest dose level exhibited minimally detectable (<0.3%) mixed donor chimerism at 10.5 months and 12 months post-transplant.
No detectable mixed chimerism was observed in the malignant cell lineage (CD3+ T-cells) for this patient; mixed chimerism was only observed in healthy nonmalignant blood cells (CD33+ myeloid cells)
In contrast, for the control arm (transplant alone), eight patients have now been enrolled and only one has achieved and maintained complete donor chimerism to date. Two patients relapsed approximate six months post-transplant and one of these patients died approximately three months later. A third patient required clinical intervention on day 133 because of concerns of impending relapse, and a fourth died 21 days post-transplant.
Opening of expansion cohorts at the recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints is planned for the third quarter of 2024.
Completion of Phase 1 enrollment and reporting of one-year clinical and translational data on initial patients is anticipated in the second half of 2024.
Expects to initiate registration trial pending feedback from regulatory authorities and report two-year relapse data in 2025.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The Company’s lead TCR-T 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 Company is also developing multiplex TCR-T 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 candidates for patients with a variety of cancers.
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