Anixa Biosciences Announces Commencement of Phase 1b Trial of its Breast Cancer Vaccine at Cleveland Clinic

On October 26, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported the initiation of a Phase 1b trial for its preventative breast cancer vaccine (Press release, Anixa Biosciences, OCT 26, 2022, View Source [SID1234622420]). The study is being conducted at Cleveland Clinic and will evaluate safety and monitor immune response.

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This novel study, funded by a grant from the U.S. Department of Defense, has begun recruitment of healthy, cancer-free participants at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. Typically, those women carry mutations in the BRCA1 or related genes and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer. During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed by the end of 2023.

A Phase 1a trial of this vaccine is currently ongoing. The Phase 1a study includes patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

"We are excited to commence the second stage of the Phase 1 trials for our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa. "While the Phase 1a trial is ongoing, the results to date have given us the confidence to move into this next study earlier than planned." Dr. Kumar added, "This vaccine has the potential to prevent the development of triple negative breast cancer, the most lethal form of breast cancer, and we look forward to advancing this promising technology through further clinical development."

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by Dr. Vincent Tuohy, Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. Dr. Tuohy will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in Anixa.