Anixa Biosciences Announces Initiation of Phase 1b Trial of Its Breast Cancer Vaccine at Cleveland Clinic

SAN JOSE, California., October 26, 2022 /PRNewswire/ — Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on treating and preventing cancer and infectious diseases, today announced the start of a phase 1b Trial for its preventive breast cancer vaccine. The study is being conducted at the Cleveland Clinic and will assess safety and monitor immune response.

This novel study, funded by a US Department of Defense grant, began recruiting healthy, cancer-free participants at high risk of breast cancer who chose to undergo a voluntary bilateral mastectomy to lower their risk. Typically, these women carry mutations in BRCA1 or related genes and are therefore at risk of developing triple-negative breast cancer or have a high family risk of any form of breast cancer. Over the course of the study, participants will receive three vaccinations spaced two weeks apart and will be closely monitored for side effects and immune response. The study is expected to be completed by the end of 2023.

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

“We are excited to begin the second phase of Phase 1 trials for our breast cancer vaccine,” said Dr. Amit Kumar, Chairman and CEO of Anixa. “Although the Phase 1a trial is ongoing, the results to date give us confidence to begin this next trial ahead of schedule.” dr Kumar added, “This vaccine has the potential to prevent the development of triple-negative breast cancer, the deadliest 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, uses endogenously produced proteins that have a function at certain times in life, but then “retire” and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found in normal, senescent tissue after lactation but is present in the majority of triple-negative breast cancers. Activation of the immune system against this “retired” protein provides preventive immune protection against emerging breast tumors expressing α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, allowing the immune system to launch a response against newly developing tumors to prevent them from growing. This vaccine technology was developed by Dr. Vincent Tuohy, Mort and Iris November Distinguished Chair for Innovative Breast Cancer Research in the Division of Inflammation and Immunity at the Cleveland Clinic’s Lerner Research Institute. dr Tuohy is credited with inventing the technology, which the Cleveland Clinic has exclusively licensed to Anixa Biosciences. dr Tuohy will receive a portion of the commercialization proceeds that the Cleveland Clinic receives for this technology, and also has a personal interest in Anixa.

About Anixa Biosciences, Inc.

Anixa is a clinical-stage biotechnology company with a number of programs targeting cancer and infectious diseases. Anixa’s portfolio of therapeutics includes a cancer immunotherapy program being developed in collaboration with the Moffitt Cancer Center that utilizes a novel type of CAR-T known as chimeric endocrine receptor-T cell (CER-T) technology, and with partner MolGenie GmbH, a COVID-19 program focused on compounds targeting M^professional SARS-CoV-2 enzyme largely conserved in all recently identified variants. The company’s vaccine portfolio includes a novel vaccine being developed in collaboration with the Cleveland Clinic to prevent breast cancer — specifically triple negative breast cancer (TNBC), the deadliest form of the disease — and a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunization against ‘retired’ proteins that have been found to be expressed in certain forms of cancer. Anixa’s unique business model of partnering with world-renowned research institutions for clinical development enables the company to continuously explore emerging technologies in complementary areas for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa TwitterLinkedIn and Facebook.

Forward-looking statements: Statements that are not historical facts may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, but instead reflect Anixa’s current expectations of future events and results. We generally use the words “believe,” “expect,” “intend,” “plan,” “anticipate,” “likely,” “will,” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those that express our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which could cause our actual results, performance or achievements or industry results to differ materially from future results, achievements or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, the factors set forth in “Item 1A – Risk Factors” and other sections of our most recent annual report on Form 10-K and in our quarterly reports on Form 10-Q and current reports on Form 8- K We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to place undue reliance on such forward-looking statements in evaluating the information contained in this press release.

Contact:
Mike Catelani
[email protected]
408-708-9808

SOURCE Anixa Biosciences, Inc.