Anixa Biosciences and Cleveland Clinic Present Positive Data for Phase 1 Breast Cancer Vaccine Study

Immune responses were observed at all doses

SAN JOSE, CA., April 17, 2023 /PRNewswire/ — Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company specializing in the treatment and prevention of cancer, today announced that the Cleveland Clinic presented the most recent data from the Phase 1 trial of its breast cancer vaccine. The data presented showed that in vaccinated women who have been tested to date, varying levels of antigen-specific T cell responses have been observed at all doses. The presentation was made by G. Thomas Boudd, MD, of the Cleveland Clinic’s Taussig Cancer Institute and the study’s principal investigator. This breast cancer vaccine technology was invented at the Cleveland Clinic, where the trial is underway, and Anixa is the exclusive worldwide licensee. The trial is funded by a US Department of Defense grant to the Cleveland Clinic.

The phase 1a study is designed to assess 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 had triple negative breast cancer (TNBC) within the last three years and were curatively treated after following 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.

“We are testing this vaccine to determine if a vaccinated patient’s immune system is trained to destroy cancer cells expressing α-lactalbumin, a protein present on TNBC cancer cells and not on normal cells. To assess the effect of vaccination, immune-mediated biomarkers of T cell activation and production of specific antibodies against α-lactalbumin are being measured. We are encouraged by the data and look forward to further studies,” said the dr. Amit KumarChairman and CEO of Anixa Biosciences.

“We are pleased that varying degrees of antigen-specific T cell responses have been observed at all dose levels tested to date, however, the Phase 1 trial is not designed to determine whether responses are sufficient to prevent recurrence or primary tumorigenesis,” said Dr. Budd. “We expect successive studies to determine the effectiveness of immune responses in preventing cancer.”

About Triple Negative Breast Cancer
One in eight women in the United States will be diagnosed with invasive breast cancer at some point in her life. About 10-15% of these diagnoses are TNBC, but TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher recurrence rate. This form of breast cancer is twice as likely to occur in African American women, and approximately 70-80% of breast tumors that occur in women with mutations in the BRCA1 genes are triple negative breast cancers.

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then “retreat” and disappear from the body. One of these proteins is a breast-specific lactation protein, α-lactalbumin, which is no longer found after lactation in aging normal tissues, but which is present in the majority of triple-negative breast cancers. Activation of the immune system against this “reprocessed” protein provides preventive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, allowing the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuhy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at the Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy was the inventor of the technology, which the Cleveland Clinic has granted an exclusive license to Anixa Biosciences. He was entitled to a portion of the marketing revenue received by Cleveland Clinic and also owned shares in Anixa.

About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa’s therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with the Moffitt Cancer Center, which uses a new type of CAR-T, known as endocrine receptor technology. chimeric T (CER-T). The company’s vaccine portfolio includes a new vaccine developed in collaboration with the Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the deadliest form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against “removed” proteins that have been shown to be expressed in certain forms of cancer. Anixa’s unique business model of partnering with world-renowned clinical development research institutes enables the company to continuously review emerging technologies in complementary areas for further development. and subsequent marketing. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook And Youtube..

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SOURCEAnixa Biosciences, Inc.