TScan Therapeutics has reported encouraging results from its ongoing ALLOHA™ Phase 1 trial evaluating TCR-T cell therapies for blood cancers, marking a significant advancement in cellular therapy development.
The trial data, presented at the 66th ASH Annual Meeting, revealed remarkable efficacy in preventing disease relapse. Only 2 out of 26 patients (8%) in the treatment arm experienced relapse, compared to 4 out of 12 patients (33%) in the control group. The median time to relapse was not reached in TCR-T-treated subjects, while control arm patients showed a median time to relapse of 160 days.
Clinical Safety and Efficacy Profile
The company's lead candidates, TSC-100 and TSC-101, demonstrated favorable safety profiles with no dose-limiting toxicities. Adverse events aligned with typical hematopoietic cell transplantation outcomes. Notably, the TCR-T cells showed sustained presence in patients, detectable more than one year post-infusion, with a clear dose-persistence relationship.
"The progress we achieved across our pipeline in 2024 has paved the way for a transformative year ahead," stated Gavin MacBeath, Ph.D., Chief Executive Officer. "We are encouraged by the ALLOHA™ heme data presented at ASH."
Strategic Development Plans
TScan has decided to focus future development on TSC-101, which can treat approximately 98% of patients with HLA type A*02:01. The company plans to:
- Initiate a registration trial for TSC-101 in the second half of 2025
- Present additional data, including two-year relapse data, by year-end
- File an IND for TSC-102-A0301, targeting CD45 on HLA-A*03:01, in H2 2025
Solid Tumor Program Advancement
The company's PLEXI-T™ solid tumor program continues to expand, with seven TCR-T therapies now cleared for clinical development. The strategy involves treating patients with multiple TCR-T candidates to overcome tumor heterogeneity and resistance. Recent developments include:
- FDA clearance for a new TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201)
- Plans to treat the first patient with multiplex therapy in H1 2025
- Expected safety and response data for multiplex therapy in H2 2025
Financial Position
TScan has strengthened its financial position through strategic transactions:
- Completed a $30 million registered direct offering at a 37% premium
- Secured a non-dilutive term loan facility of up to $52.5 million from Silicon Valley Bank
- Maintained a strong cash position of $290.1 million as of December 31, 2024
- Extended cash runway into the first quarter of 2027
The company's robust financial standing positions it well to advance its clinical programs and achieve upcoming milestones in both hematologic and solid tumor indications.
