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Anixa Biosciences (Nasdaq:ANIX) Looking Forward to Initiating Human Trials with Breast Cancer Vaccine by End of 2020


Rochester, NY -- (ReleaseWire) -- 05/28/2020 --While Anixa Biosciences (NASDAQ:ANIX) has gained some visibility for their recent work on Covid-19, it's important to understand that that company has some additional compelling assets. Today, I want to discuss their breast cancer vaccine program. I wont discuss all the market size details about breast cancer as most of us know that breast cancer is the most common cancer diagnosed in women in the US and throughout the world. The most dangerous type of breast cancer is something called, triple negative breast cancer (TNBC). It is called TNBC because the cancer is negative for hormone receptors as well as Her2neu, a marker for a type of breast cancer. Because it does not have those receptors, TNBC grows rapidly without growth signals provided by the proteins that bind to those receptors. Roughly on quarter of all breast cancers are TNBC, but because of its aggressiveness and lack of good therapies for TNBC, it is the cause of roughly half of breast cancer mortality.

Women who have mutations in their in genes known as BRCA genes, are at high risk of getting breast cancer in their lifetimes and typically the type of cancer they get is TNBC. Because of these facts, many women are choosing to have their breasts and ovaries removed even though they are healthy. They have chosen to not take the chance of the cancer ever developing as they might die. This is a bid decision for a woman, as it is a painful, risk-laden, expensive and disfiguring surgery. The most famous case of a woman opting for this surgery is that of mega-actress Angelina Jolie having her breasts ovaries removed. Since she was positive for the BRCA mutations and members of her family had suffered and died of breast cancer, she chose the surgery before she had cancer.

With that context, what is Anixa doing about this? Anixa is developing a breast cancer vaccine that could eventually eliminate TNBC, as well as other cancers. This vaccine was invented at the Cleveland Clinic, which is one of the top research hospitals in the country (as a fun exercise, if you Google the "best hospitals in the US", the Cleveland Clinic always comes out as number 1 or 2, regardless of who is making that list). A brilliant immunologist identified a protein that shows up in the mammary glands when a woman is lactating, after giving birth to a child. When the woman stops lactating, the protein disappears until the next child is born. If the woman is not giving birth anymore, the protein is gone UNTIL the woman develops breast cancer, including TNBC. This immunologist discovered that the protein shows up again when breast cancer occurs. He and is research team postulated that if they could immunize women against this protein (by making a vaccine) they might eliminate the onset of breast cancer. This research has been ongoing at the Cleveland Clinic for over a decade.

The animal studies showed that this vaccination approach eliminated the onset of breast cancer in 100% of the mice that were immunized. Anixa licensed this technology and is working with the Cleveland Clinic to take this vaccine through human testing and eventual FDA approval. We have to understand that no matter how good the animal data is, there is always risk that it will not work in humans, so we have to see what the human data says. Anixa and the Cleveland Clinic hope to take this vaccine into human testing by the end of 2020. There is a team at the Cleveland Clinic working with Anixa to conduct the human trials. Imagine if this works in humans as well as it did in animals. Women would just have to get a shot and may never have to worry about breast cancer. The market opportunity is massive in the US and worldwide. The impact on women would be tremendous and the economic value to the healthcare system would be equally impactful. In addition, all of these facts, including the compelling scientific data, enabled the Cleveland Clinic to get a Department of Defense grant to fund this program all they way up to completion of two Phase 1 trials. If the data in the funded trials look positive, maybe the government will fund the Phase 2 and 3 trials. What does this mean for Anixa. First, Anixa owns a very promising asset and is working with the Cleveland Clinic to develop it. Most importantly, Anixa is not spending money on the development because the DOD is funding this program. It's the best of all possible worlds for Anixa.

About Anixa Biosciences, Inc.
Anixa is a publicly-traded biotechnology company developing a number of programs addressing cancer and infectious disease. Anixa's therapeutic portfolio includes a cancer vaccine technology focused on the immunization against ?-Lactalbumin to prevent triple negative breast cancer (TNBC), 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 diagnostic portfolio consists of Cchekâ„¢, a liquid biopsy technology for early detection of solid tumors based on the body's immune response to the presence of a malignancy. Anixa continually examines emerging technologies in complementary fields for further development and commercialization. Additional information is available at

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 those concerning 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.

Anixa contact:
Mike Catelani

Tiberend Strategic Advisors, Inc.

Miriam Miller (Investors)

Johanna Bennett (Media)

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