SAN JOSE, Calif., Dec. 21, 2020 /PRNewswire/ -- Anixa
Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused
on the treatment and prevention of cancer and infectious diseases,
announced today that the U.S. Food and Drug Administration (FDA)
has cleared the Investigational New Drug (IND) application for its
breast cancer vaccine.
- This breast cancer vaccine technology was invented and
developed by Cleveland Clinic immunologist Dr. Vincent Tuohy, and his research team.
- Oncologist, Dr. Thomas Budd,
also of Cleveland Clinic, will lead the clinical trial.
- Anixa Biosciences has an exclusive worldwide license to the
- The technology immunizes against a protein called
alpha-lactalbumin that is expressed in the mammary glands of women,
only during the latter part of gestation and during lactation.
After lactation ceases, this protein is no longer expressed until a
woman develops breast cancer. In a vaccinated woman, the
researchers anticipate that these cancer cells will be destroyed by
the immune system before they have the opportunity to grow into a
- The initial focus is Triple Negative Beast Cancer, but this
technology is expected to potentially prevent other types of breast
- Animal studies showed notable ability to prevent breast
- The preclinical studies and two trials of this vaccine are
being funded by the U.S. Department of Defense.
Dr. Amit Kumar, President and CEO
of Anixa stated, "We are pleased that the FDA has authorized us to
commence human clinical trials of our potentially paradigm-shifting
vaccine for the prevention of breast cancer. This approval
triggers a cascade of events and activities, that will eventually
lead to recruitment of patients and initiation of the trial."
"This is a significant milestone for our program. Our
vision has always been to prevent cancer before it arises," said
Dr. Tuohy. "We are looking forward to beginning clinical
trials in patients."
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 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, the risk
that clinical trial data in humans will not be comparable to data
obtained in animal studies, including as it relates to our
prophylactic breast cancer vaccine, as well as 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
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SOURCE Anixa Biosciences, Inc.