Anixa Biosciences and Moffitt Cancer Center File IND Application for Ovarian Cancer CAR-T Therapy

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Mar 22, 2021, 08:30 ET

SAN JOSE, Calif., March 22, 2021 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that an IND (Investigational New Drug) application for its ovarian cancer CAR-T (Chimeric Antigen Receptor T-cell) therapy has been filed with the U.S. Food and Drug Administration.

This CAR-T therapy was invented by a team led by Dr. Jose Conejo-Garcia, while he was at the Wistar Institute. Dr. Conejo-Garcia is currently Chair of the Department of Immunology at Moffitt Cancer Center (MCC), where the IND enabling studies were performed, and where the clinical trial will be conducted, under the leadership of Dr. Robert Wenham, Chair of Gynecological Oncology at MCC. Anixa has a worldwide, exclusive commercial license to the technology.

The technology targets the follicle stimulating hormone receptor (FSHR) with engineered T-cells that use the follicle stimulating hormone as a homing mechanism. FSHR is found at immunological levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.

Dr. Wenham stated, "We are pleased to file this IND application, since women who have recurrent ovarian cancer have very few options. We hope the work of our scientific and clinical team at Anixa and MCC yields results that will address a critical unmet medical need."

"We are looking forward to the response from the FDA, and to eventually testing this therapy in humans," stated Dr. Conejo-Garcia. "This is a very high-profile program at MCC, as we believe this could be the first CAR-T therapy that has the potential to achieve clinical success in a solid tumor indication."

"This IND application is a major milestone for Anixa and our partners at MCC," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "This is our second IND application filed within the last few months. Upon clearance from the FDA and commencement of the trial, we expect to have two programs in the clinic."

About Anixa Biosciences, Inc.
Anixa is a publicly-traded biotechnology company developing a number of programs addressing cancer and infectious disease. Anixa's therapeutics portfolio includes a cancer immunotherapy program which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology, and a Covid-19 therapeutics program focused on inhibiting certain viral protein function. The company's vaccine portfolio includes a vaccine to prevent breast cancer, and specifically triple negative breast cancer (TNBC), the most deadly form of the disease, and a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against specific proteins that have been found to be expressed in certain forms of cancer. Anixa continually examines emerging technologies in complementary fields for further development and commercialization. Additional information is available at www.anixa.com.

Forward-Looking Statements: Statements that are not historical fact 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 facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including, but not limited to, those concerning the progression of the IND application for the ovarian cancer CAR-T therapy and whether the ovarian cancer CAR-T therapy program will yield positive results or achieve clinical success, and any other of our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as 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 statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

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SOURCE Anixa Biosciences, Inc.