TScan Therapeutics completed enrollment of Cohort C in its Phase 1 ALLOHA trial, the first allogeneic hematopoietic cell transplantation study of its lead TCR‑T therapy, TSC‑101. The cohort, which includes patients with acute myeloid leukemia, myelodysplastic syndrome and acute lymphoblastic leukemia, is being treated using a commercial‑ready manufacturing process that shortens production time from 17 days to 12 days and reduces cost of goods, thereby improving T‑cell activity.
The company also received FDA clearance for two new INDs, TSC‑102‑A01 and TSC‑102‑A03, which target the CD45 antigen in patients with HLA‑A01:01 and HLA‑A03:01, respectively. These approvals broaden the heme pipeline and nearly double the U.S. addressable patient population for TScan’s TCR‑T therapies.
CEO Gavin MacBeath said, "We are excited about the potential of TSC‑101 to treat residual disease and prevent relapse in patients undergoing hematopoietic cell transplantation." He added, "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."
The company plans to share safety and early chimerism data from Cohort C in Q2 2026 and launch a pivotal trial for TSC‑101 in Q2 2026. Phase 1 trials for the new INDs are slated for the second half of 2026, positioning TScan to accelerate development and move closer to regulatory approval.
TScan’s strategic shift toward its heme program, including a 30% workforce reduction and an extended cash runway into the second half of 2027, underscores the company’s focus on scaling the commercial‑ready platform and delivering on the clinical promise demonstrated by 100% relapse‑free survival at two years versus 25% in the control arm.
The FDA clearances and enrollment milestone reinforce TScan’s trajectory to prevent relapse after allogeneic transplantation and expand its pipeline, providing a stronger foundation for future commercialization and potential market impact.
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