Prnewswire·2026-02-09 13:00Core Insights - Anixa Biosciences is reporting promising outcomes from its ongoing Phase 1 clinical trial of CAR-T therapy for recurrent ovarian cancer, with several patients exceeding expected survival rates at low dose levels [1][2][3] Group 1: Trial Overview - The Phase 1 trial is focused on adult women with recurrent ovarian cancer who have not responded to standard chemotherapy and have progressed after two or more therapies [2] - Twelve patients have been treated at four dosage levels, with seven patients living beyond the expected median survival of three to four months [2] - Notably, one patient survived 28 months post-treatment, and three others have survived over one year [2] Group 2: Safety and Efficacy - The trial primarily aims to demonstrate safety, and the absence of dose-limiting toxicities (DLTs) has allowed for significant dose escalation [3][5] - The dosing may increase from 1×10 to as high as 1×10 CAR-positive cells per kilogram, representing a two-order-of-magnitude increase [3] - The favorable safety profile is attributed to the intra-peritoneal delivery method, which may enhance localized tumor targeting while reducing systemic toxicity [3] Group 3: Future Directions - The next patient cohort will receive higher doses following a lymphodepletion regimen, which is expected to create a more favorable environment for CAR-T cell activity [4] - The regulatory approval for the protocol amendment allows for further evaluation of both safety and potential therapeutic benefits as the study progresses [5] - Anixa plans to discuss trial observations and future plans in an upcoming fireside chat on February 10, 2026 [1][6] Group 4: Technology and Collaboration - Anixa's CAR-T therapy, lira-cel, targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells and certain cancer cells [7] - The company collaborates with Moffitt Cancer Center, a leader in cancer immunotherapy, to develop its CAR-T therapy and other cancer vaccines [8]