Cellectis' Lasme-cel Achieves 100% ORR in Phase 2, Targets 2028 BLA; Strong Pipeline Updates
Summary
Cellectis reported full-year 2025 financial results and provided a highly positive business update, primarily driven by strong clinical data for its lead CAR-T therapies and a significant scientific breakthrough. The company's lasme-cel therapy for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) achieved a 100% overall response rate (ORR) in the target Phase 2 population, with all patients becoming transplant-eligible, and a Biologics License Application (BLA) submission is anticipated in 2028. Additionally, eti-cel for r/r non-Hodgkin lymphoma (r/r NHL) showed encouraging Phase 1 preliminary data with an 88% ORR. Cellectis also announced a pivotal advance in gene therapy with its circular single-stranded DNA (cssDNA) technology, demonstrating superior efficiency and persistence as a non-viral DNA donor template. These updates represent a significant de-risking and potential value inflection for the company's pipeline and technology platform, positioning it for future growth and regulatory milestones. Traders will be closely watching the interim Phase 2 data for lasme-cel in Q4 2026.
At the time of this announcement, CLLS was trading at $3.54 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $255.3M. The 52-week trading range was $1.10 to $5.48. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.