On August 7, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company’s breast cancer vaccine with Keytruda (pembrolizumab) (Press release, Anixa Biosciences, AUG 7, 2023, View Source [SID1234633896]). An expansion of the ongoing Phase 1 dose escalation trial of Anixa’s breast cancer vaccine, this treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.
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Anixa’s breast cancer vaccine is designed to generate T cells that target triple negative breast cancer ("TNBC"). Keytruda, a therapy marketed by Merck (NYSE: MRK), is approved for use with chemotherapy before surgery and then alone after surgery to treat both high-risk early-stage and advanced TNBC.
Keytruda is a type of immunotherapy known as a checkpoint inhibitor. T cells, a type of white blood cell involved in the body’s immune system, have receptor proteins on their surface called checkpoints. These checkpoints are utilized by other immune cells to modulate the activity of T cells. Cancer cells, such as TNBC cells, have developed mechanisms to target checkpoints to inhibit the activity of T cells, as well as other immune cells. This inhibition enables the cancer cells to escape destruction by cytotoxic T cells. One of these key checkpoint receptors is known as PD-1 (Programmed Cell Death Protein-1). TNBC, like many other cancers, expresses a protein that binds to the PD-1 protein on T cells and essentially turns them "off." Keytruda is a monoclonal antibody, which blocks the ability of the cancer cells to inactivate T cells by shielding the PD-1 receptor.
Dr. Amit Kumar, Chairman and CEO of Anixa stated, "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. We are grateful to the U.S. Department of Defense for providing the funding for this new arm of the trial and look forward to Cleveland Clinic’s presentation of the updated data from this trial at the San Antonio Breast Cancer Symposium (SABCS) in December."
About Anixa’s Breast Cancer Vaccine Clinical Trial
The Phase 1a study is designed to evaluate the safety of the vaccine, identify the Maximum Tolerated Dose (MTD), and monitor the immune response in vaccinated women. All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care. At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence.
About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.