TSC-101 - (ALLOHA-2)
- Indication
- Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
- Stage
- phase3
- Event
- Phase 3
- Details
September 2, 2026: TScan Therapeutics (NASDAQ: TCRX) announced a strategic reorganization to prioritize its in vivo-engineered TCR-T solid tumor program, advancing two candidates targeting PRAME and MAGE-A4 into IND-enabling studies. The company expects preclinical data in Q1 2027, its first IND filing in Q3 2027, and Phase 1 initiation in Q4 2027.
For heme malignancies, TScan reported updated Phase 1 ALLOHA data for TSC-101 in patients undergoing allogeneic HCT: all 13 patients currently being tracked in Cohort C showed complete donor chimerism, including two who had relapsed and then converted after a third TSC-101 infusion and/or targeted agents. One previously disclosed non-relapse death was unrelated to TSC-101; infusions were generally well tolerated with adverse events consistent with post-HCT events. Despite these data, TScan paused further enrollment in the Phase 3 ALLOHA-2 study of TSC-101 due to insufficient capital, while continuing follow-up of 7 treated ALLOHA-2 patients and the 13 Cohort C patients. Updated Cohort C data are planned for Q4 2026, and data from all patients treated with the commercial-ready manufacturing process are planned for Q2 2027.
The company is also seeking partnerships for its heme and HLA-B*27-associated autoimmune programs, including ankylosing spondylitis. The restructuring includes a ~75% workforce reduction and is expected to extend cash runway into Q4 2027.
- Source
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