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TCRX-News
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TScan Therapeutics Reorganizes to Focus on Solid Tumor Program, Cuts Workforce by 75%
TScan Therapeutics announced it is strategically reorganizing to prioritize its in vivo solid tumor program, advancing two product candidates to IND-enabling studies. The company also announced updated data from Cohort C of its Phase 1 ALLOHA study of TSC-101 in heme malignancies. All patients currently being tracked show complete donor chimerism, including two patients who had previously relapsed. TScan has paused further enrollment in the Phase 3 ALLOHA-2 study of TSC-101 due to insufficient capital needed to complete the trial. The company will continue to track the seven patients already enrolled on the treatment arm of ALLOHA-2, as well as the 13 patients in Cohort C of the Phase 1 ALLOHA study. The company remains committed to reporting updated data on Cohort C patients in Q4 and on all patients treated with the commercial-ready manufacturing process in Q2 2027 and intends to pursue strategic partnerships for its heme and autoimmune programs. As part of the strategy to prioritize the solid tumor program, the company will undergo a workforce reduction of approximately 75%.
TScan Reports Q2 Revenue of $1.05M, Below Consensus
Reports Q2 revenue $1.05M, consensus $2.5M. "This is a transformative time for TScan with our first pivotal study now enrolling at major transplant centers across the U.S.," said Gavin MacBeath, Chief Executive Officer. "A key priority during the first half of this year was demonstrating the performance of our improved commercial-ready manufacturing process. Data from Cohort C of the ALLOHA trial, generated using this process, reinforces our confidence in both our manufacturing and the clinical potential of TSC-101 as we enter our Phase 3 study. Building on the encouraging efficacy we have observed with TSC-101, we are also expanding our heme program to address additional HLA types, with Phase 1 trials of TSC-102-A01 and TSC-102-A03 expected to begin in the fourth quarter of this year."
TScan Therapeutics Infuses First Patient with TSC-101
TScan Therapeutics announced that the first patient has been infused with TSC-101 in the pivotal Phase 3 ALLOHA-2 trial. The patient, who was enrolled in June, has now received their first infusion of TSC-101 following successful stem cell engraftment. The trial is investigating the efficacy and safety of TSC-101 for the treatment of residual disease to prevent relapse following allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia and myelodysplastic syndromes.
TScan Therapeutics ALLOHA Study Data Update
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 Sign Agreement to Evaluate Automated Production of TSC-101
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.
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