Breast Cancer Vaccine Candidate Opens Clinical Trial Enrollment

Anixa Biosciences, Inc. today announced that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company's breast cancer vaccine candidate with Keytruda®.

This treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.

Anixa's breast cancer vaccine is designed to generate T cells that target triple-negative breast cancer ("TNBC"). This vaccine takes advantage of endogenously produced proteins that function at certain times in life but then become "retired" and disappear from the body.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated in a press release on August 7, 2023, "Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect."

"If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent."

Keytruda, a type of immunotherapy known as a checkpoint inhibitor marketed by Merck, is approved for use with chemotherapy before surgery and then alone after surgery to treat high-risk early-stage and advanced TNBC. 

The Phase 1a study evaluates the vaccine's safety, identifies the Maximum Tolerated Dose, and monitors the immune response in vaccinated women.

According to the Company, one in eight women in the U.S. will be diagnosed with invasive breast cancer at some point in their lives.