Anixa Biosciences’ breast cancer vaccine shows positive Phase 1 results

Anixa Biosciences announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense. The majority of patients developed ELISpot – T-cell – responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients. Among the doses studied, Dose Level 1 was determined to be a usable immunologic dose as well as the maximum tolerated dose. No significant side effects were observed, at the MTD, besides irritation at the sites of injection. Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine’s safety and immunologic effects in two additional patient cohorts. The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the company’s breast cancer vaccine with Keytruda in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy. The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies. Anixa is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic.