Acute Myeloid Leukemia (AML), Acute lymphoblastic leukemia (ALL), Myelodysplastic syndrome (MDS)
TCRXTScan TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Phase 1 data readout for TSC-101 in Acute Myeloid Leukemia (AML), Acute lymphoblastic leukemia (ALL), Myelodysplastic syndrome (MDS). The expected timing is based on the latest available company guidance and may change.
ALLOHA heme trial. 5/29/24- Received RMAT Designation. 12/9/24- Presented updated data at the ASH'24. 11/3/25- Positive end of Ph1 meeting & agreement reached with FDA. 11/12/25:- Present updated ALLOHA Ph1 data at ASH Dec 6, 2025; pivotal trial launch planned Q2 2026. 12/06/25:- Updated ALLOHA Ph1 data at ASH 2025 show durable remissions, good safety, improved commercial-ready manufacturing process. 02/26/26:- Completed Cohort C enrollment; ALLOHA Ph1 Cohort C data and TSC-101 pivotal trial start expected Q2 2026. 03/04/26:- Plan updated Cohort C data in H2 2026; early Cohort C data and pivotal trial remain expected Q2 2026. 05/06/26:- Reiterated ALLOHA Ph1 Cohort C early data and ALLOHA-2 Ph3 start in Q2 2026. 06/22/26:- Presented Cohort C Ph1 data. On track to enroll first ALLOHA-2 Ph3 patient in June 2026. 07/29/26:- First ALLOHA-2 Ph3 patient infused with TSC-101 for AML/MDS post allo-HCT. 08/12/26:- First ALLOHA-2 Phase 3 patient was dosed. Updated ALLOHA Phase 1 Cohort C data is expected in Q4 2026; over one-year follow-up data is expected in H1 2027; ALLOHA-2 topline data is expected Mid-2028.
Verification
Confirm timing and program details against the company announcement or filing.