TCRX News & Events

TScan Therapeutics presented data from Cohort C of the ongoing ALLOHA Phase 1 study, evaluating TSC-101 generated with the commercial-ready manufacturing process, in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation. Overall, 19 patients were enrolled in Cohort C: approximately 90% manufacturing success rate with commercial-ready process; 14/19 patients went to transplant and received their first infusion of TSC-10; 10/14 patients have received their planned second infusion, and 1/14 patients received a third infusion; 3/19 patients did not proceed to transplant due to clinical reasons. Chimerism data as observed by high sensitivity NGS assay with assay cut-off of 0.2%: 11 of 14 patients achieved complete donor chimerism within approximately 3 weeks of receiving their first infusion of TSC-101 and 2 of the remaining 3 patients are approaching complete donor chimerism. One patient with TP53 mutated AML remained in complete donor chimerism 6 months post-HCT. TSC-101 infusions were generally well-tolerated, safety was consistent with Cohort A, and observed adverse events were consistent with post-HCT adverse events.

Cellares and TScan Therapeutics announced an agreement to evaluate automated clinical manufacturing of TSC-101, TScan's lead TCR-T therapy candidate for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes, through a comprehensive technical and operational assessment of Cellares' automated manufacturing and testing platforms. TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation. The therapy candidate uses a gene modification approach to engineer T cells from a healthy donor into a patient-specific cell therapy product. As TScan advances TSC-101 towards a pivotal trial, which is expected to begin in the second quarter of 2026, the Company is evaluating Cellares' automated manufacturing platform as a scalable and economical path to future commercial demand. Under the agreement, Cellares will automate the TSC-101 manufacturing and testing processes on the Cell Shuttle, its end-to-end manufacturing platform, and the Cell Q, its automated quality control and release testing system. These closed-system, fully automated workflows are designed to reduce process variability, minimize labor intensity, and enable consistent execution across runs and geographies, delivering the manufacturing economics and reliability that large-scale commercial production requires.

Reports Q1 revenue $982,000, consensus $2.5M. "2026 will be a critical year for TScan as we advance our mission to deliver transformative T cell therapies to patients. We have multiple key milestones on the horizon, anchored around the planned initiation of our Phase 3 study of TSC-101 in patients with AML and MDS undergoing allogenic hematopoietic cell transplantation," said Gavin MacBeath, Chief Executive Officer. "We look forward to sharing initial data from Cohort C of our Phase 1 ALLOHA trial, where we have enrolled and treated over 10 patients with our commercial-ready manufacturing process. The robust enrollment in this cohort underscores strong physician support, providing us greater conviction as we prepare to launch the pivotal study."