TScan Therapeutics disclosed that all three patients who received its TSC‑101 therapy remained relapse‑free and maintained complete donor chimerism after two years of follow‑up, compared with only one of four control‑arm patients who relapsed. The data, presented in a poster at the 67th American Society of Hematology (ASH) meeting in Orlando, Florida, on December 6‑9, 2025, also showed no dose‑limiting toxicities and a trend toward improved relapse‑free and overall survival, with hazard ratios of 0.50 (p = 0.23) and 0.61 (p = 0.52) respectively.
The trial’s safety profile is notable: no dose‑limiting toxicities were observed, and all treated patients achieved complete donor chimerism, a key marker of graft success. Survival trends, while not yet statistically significant, favor TSC‑101, suggesting the therapy may reduce the high relapse rate that plagues allogeneic hematopoietic cell transplantation. The data also highlighted a favorable outcome in the subset of patients with TP53 mutations, a group traditionally associated with poor prognosis.
TScan’s leadership highlighted that the FDA has agreed on a pivotal study design that mirrors the Phase 1 trial, providing a clear regulatory pathway. The company also announced a commercial‑ready manufacturing process that cuts production time from 17 to 12 days, a development that could lower costs and accelerate future trial enrollment. With these operational gains, TScan plans to initiate the pivotal study in the second quarter of 2026, positioning the company to advance toward regulatory approval and market entry.
Financially, the company’s Q3 2025 earnings, released on November 12, 2025, beat analyst expectations with an EPS of –$0.28 versus –$0.35 forecast, and revenue of $2.51 million versus $1.98 million expected. The earnings beat reflects disciplined cost management amid a $35.71 million net loss, driven largely by ongoing R&D investment. The positive financial performance underscores the company’s ability to fund its clinical pipeline while maintaining fiscal discipline.
Chief Medical Officer Chrystal U. Louis said, “These updated data from our Phase 1 study continue to highlight a positive safety and efficacy profile of TSC‑101 in patients with heme malignancies undergoing allogeneic HCT. All three patients who reached two years of follow‑up have no detectable disease and remain relapse‑free with complete donor chimerism.” Chief Executive Officer Gavin MacBeath added, “Following a productive meeting with the FDA, we now have a clearly defined pivotal trial design for TSC‑101 and an improved commercial‑ready manufacturing process. We are focused on advancing this promising program for patients with AML and MDS and look forward to sharing updated results from the ALLOHA Phase 1 trial at ASH next month.”
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.