Anixa Biosciences’ CAR-T Patients Survive up to 28 Months in Phase 1 Trial
Anixa Biosciences reported that in its Phase 1 lira-cel ovarian cancer CAR-T trial, one patient survived 28 months and three others 17–18 months versus a median expectancy of 3–4 months, while four additional participants reached 11, 11, 8 and 7 months. No dose-limiting toxicities, ICANS or significant CRS occurred.
1. Phase 1 Trial Overview
Anixa Biosciences is conducting a Phase 1 trial of liraltagene autoleucel (lira-cel), a follicle-stimulating hormone receptor-targeted CAR-T therapy for recurrent ovarian cancer. The trial enrolls adult women who have progressed after at least two prior therapies to evaluate safety, tolerability and preliminary clinical activity.
2. Updated Survival Data
Updated observations show one patient surviving 28 months and three others at 17 and 18 months, all substantially beyond the 3–4 month median expected survival for advanced recurrent ovarian cancer. Four additional participants reached 11, 11, 8 and 7 months of survival, with three still alive.
3. Safety Profile
No dose-limiting toxicities were encountered across the first three dose cohorts, and all administrations via the intraperitoneal route were successful. There have been no reports of Immune Effector Cell-Associated Neurotoxicity Syndrome or significant Cytokine Release Syndrome, and all observed adverse events were deemed unrelated to lira-cel.
4. Next Steps
Anixa plans to initiate the next dose cohort at approximately three times the prior dose and introduce lymphodepletion with cyclophosphamide and fludarabine to potentially enhance CAR-T cell expansion and persistence. Enrollment for the higher-dose cohort is expected to commence following protocol approval.