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TScan Therapeutics Completes Enrollment in Cohort C of Phase 1 ALLOHA™ Trial and Announces FDA Clearance of Investigational New Drug Applications for Heme Candidates TSC-102-A01 and TSC-102-A03
Completed enrollment of Cohort C in the Phase 1 ALLOHA™ trial; patients to be treated with commercial-ready manufacturing process Received FDA clearance of
About this update from Tscan Therapeutics, Inc.
[{"type":"text","content":"Completed enrollment of Cohort C in the Phase 1 ALLOHA™ trial; patients to be treated with commercial-ready manufacturing process Received FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 targeting CD45, for patients with HLA types A*01:01 and A*03:01 Plans to initiate Phase 1 study of both TSC-102 candidates in the second half of 2026 WALTHAM, Mass., Feb. 26, 2026 (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 completion of enrollment into Cohort C of the ALLOHA™ study. Patients in Cohort C are being treated using the new commercial-ready manufacturing process. The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03 for patients with HLA types A*01:01 and A*03:01, respectively. “We are excited about the potential of TSC-101 to treat residual disease and prevent relapse in patients undergoing hematopoietic cell transplantation,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “We have now enrolled over ten patients in Cohort C of the ALLOHA™ study where we are treating patients with our new commercial-ready manufacturing process. We look forward to sharing data from this cohort in the second quarter of this year, prior to launching our Phase 3 study. We are also pleased to announce that the FDA has cleared our IND applications for TSC-102-A01 and TSC-102-A03, and we look forward to initiating a Phase 1 trial with these candidates in the second half of this year. We believe the addition of these product candidates will nearly double the addressable U.S. patient population in our heme program.” “During the Tandem Meetings of ASTCT and CIBMTR, we highlighted the relationship between donor chimerism and long-term outcomes in patients following HCT,” added Chrystal U. Louis, M.D., Chief Medical Officer. “Specifically, patients that achieved complete donor chimerism by month two after transplant using a high-sensitivity assay have a significantly lower probability of relapse (HR=4.6, p=0.02) compared to those who did not achieve complete donor chimerism. We look forward to sharing early chimerism data from Cohort C and...