TCRX TScan Therapeutics Inc

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 TrialAuthors: 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 ReshefPublication Number: 924Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging Targeting Approaches of Cell Therapies for Hematologic MalignanciesSession Date & Time: Monday, December 9, 2024; 2:45 - 4:15 p.m. Pacific TimePresentation Time: 4:00 p.m. Pacific TimeLocation: 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.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including clinical updates of the ALLOHA Phase 1 trial, presentation of data, and initiation of registrational trials; the progress of the hematologic malignancies program being indicative or predictive of the success of such program; the Company’s current and future research and development plans or expectations; the structure, timing and success of the Company’s planned preclinical development and clinical trials; the potential benefits of any of the Company’s proprietary platforms, or current or future product candidates in treating patients; and the Company’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s recently approved INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.

Contacts

Heather SavelleTScan Therapeutics, Inc.VP, Investor Relations857-399-9840hsavelle@tscan.com   

Maghan MeyersArgot Partners212-600-1902TScan@argotpartners.com