TScan Therapeutics (TCRX) 25th Annual Needham Virtual Healthcare Conference summary

Technology platform and clinical strategy

• Focus on TCR-engineered T cell therapies for cancer, distinct from CAR T by targeting myeloid malignancies where CAR T is ineffective.

• Approach leverages donor-derived T cells engineered to target antigens present only on patient cells, sparing healthy donor cells post-transplant.

• Designed to enhance curative potential of bone marrow transplants for AML and MDS by reducing relapse rates.

• Phase I data show robust reduction in relapse and long-lived T cell persistence post-infusion.

Clinical results and pivotal trial plans

• Phase I ALLOHA study showed relapse-free survival hazard ratio of 0.5 and >50% reduction in relapses compared to control.

• Engineered T cells detectable in blood for over 2 years, with disease-free survival in all patients at 2 years (vs. 1/4 in control).

• Phase III pivotal trial to launch mid-2024, targeting 140 patients per arm, with top-line data expected mid-2028 and commercial launch in 2029.

• Protocol allows a third infusion for patients with impending relapse.

Manufacturing and process improvements

• Identified manufacturing process issues at higher dose levels leading to T cell exhaustion; resolved with a new, shorter 12-day process.

• Cohort C enrolled over 10 patients with the new process; early data to be shared before pivotal trial launch.

• Commercial manufacturing to be outsourced to a CDMO with capacity for several thousand patients annually.

• Anticipated cost of goods is $250,000–$260,000 per product, supporting strong profit margins at $650,000–$700,000 pricing.