TScan Therapeutics, Inc. (TCRX)

The company is a fully integrated clinical-stage biotechnology company developing T cell receptor (TCR)-engineered T cell (TCR-T) therapies for cancer. Its mission is to create T cell therapies for patients with cancer and autoimmune disorders. It uses a target discovery platform to identify the antigens recognized by T cells, and it has built a collection of therapeutic TCRs that recognize cancer-specific targets and are associated with multiple HLA types.

The lead product candidate, TSC-101, targets the HA-2 antigen in patients with HLA type A*02:01 who have acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and are undergoing allogeneic hematopoietic cell transplantation. It is designed to eliminate residual disease, promote complete donor chimerism and prevent relapse. It is in the Phase 1 ALLOHA trial, and in the fourth quarter of 2025 the company reached agreement with the FDA on a registrational path. The pivotal study will mirror the Phase 1 trial, with a biologically assigned control arm and relapse-free survival as the primary endpoint. The heme program also includes TSC-102-A01 and TSC-102-A03, allogeneic donor-derived TCR-T candidates targeting CD45-derived epitopes for patients with HLA types A*01:01 and A*03:01. In solid tumors, the company is developing multiplex TCR-T therapy, in which up to three TCR-Ts are customized to each patient's tumor targets, initially against HPV16, MAGE-A4 and PRAME. On November 3, 2025 it paused enrollment in its solid tumor Phase 1 trial (PLEXI-T) to prioritize the heme program, and it is focusing preclinical work on an in vivo engineering approach to off-the-shelf multiplexed TCR-T therapy. An early-stage autoimmune program targets ankylosing spondylitis, ulcerative colitis and scleroderma.

The customers and markets are patients with heme malignancies and solid tumors, with autoimmune disorders as an additional area. The company has no approved products. It has a research collaboration and license agreement with Amgen to identify antigens recognized by T cells in Crohn's disease. Under it, the company received a $30.0 million upfront payment and is eligible for over $500 million in success-based milestones plus tiered single-digit royalties, while Amgen retains global development and commercial rights. The company has also extended its discovery platform to CD4+ T cells through class II antigen presentation, to address autoimmune disorders with strong MHC class II linkage. Over 20 clinical sites have been activated for the TSC-101 trial.

On operations, the company has an internal, fully operational GMP facility that it believes can supply its clinical programs. Its heme manufacturing uses a non-viral transposon/transposase gene delivery system that can be applied rapidly to new TCR-T candidates and allows added enhancements, such as introducing the CD8α/β gene with the TCR so that both cytotoxic and helper T cells are engineered. To add capacity and prepare for potential commercialization, it has engaged a global contract development and manufacturing organization with worldwide commercial capabilities. The company says it will opportunistically pursue partnerships with partners that have clinical development and commercialization capabilities. The text names CAR-T and TIL therapies as alternative T cell approaches but does not identify specific competitors or the headquarters location.