TScan Agreement with FDA on Pivotal Study Design for TSC-101; Strategic Prioritization

TScan (Nasdaq: TCRX) reached alignment with the FDA on a pivotal registrational trial design for TSC-101 in AML and MDS following an End-of-Phase 1 meeting. The pivotal trial will mirror the Phase 1 ALLOHA study and use a biologically assigned internal control arm; the company expects to start the pivotal trial in Q2 2026. TScan shortened its manufacturing process from 17 to 12 days to reduce ex vivo T cell expansion and transferred the process to a CDMO.

The company dosed the first two solid tumor patients with multiplex TCR-T, paused further solid-tumor enrollment to prioritize heme development, enacted a workforce reduction of ~30% (66 employees), expects ~$45.0 million annual cost savings in 2026–2027, will take a one-time charge up to $2.3 million in Q4 2025, and extended cash runway into H2 2027. Key near-term milestones: ASH presentation on Dec 6, 2025, INDs for expanded HLA coverage in Q4 2025, and initial PLEXI-T data in Q1 2026.

https://www.stocktitan.net/news/TCRX/t-scan-therapeutics-reaches-agreement-with-fda-on-pivotal-study-54dqsi0fn85l.html