SAN JOSE, Calif., Nov. 23, 2020 /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 prophylactic breast cancer vaccine has been filed with the
U.S. Food and Drug Administration.
This vaccine technology was invented by a research team from
Cleveland Clinic, led by Dr. Vincent
Tuohy, the Mort and Iris November Distinguished Chair in
Innovative Breast Cancer Research in the Department of Inflammation
and Immunity at Cleveland Clinic's Lerner Research Institute. Anixa
has a worldwide, exclusive license to this technology.
The technology takes advantage of self-proteins that have a
function at certain times in life, but then become "retired" and
disappear from the body. One such protein, alpha-lactalbumin,
is expressed only in the mammary glands during lactation and then
disappears once lactation ceases. Dr. Tuohy discovered that
this protein is abnormally expressed again when a woman contracts
breast cancer, especially Triple Negative Breast Cancer (TNBC), the
most deadly form of this disease. Dr. Tuohy postulated that
if women could be immunized against this protein after their
childbearing years, the immune system could be trained to destroy
cancer cells as they arise while ignoring normal cells that no
longer express this protein, thus making it difficult for the
cancer to gain critical mass. Early studies to test this
theory demonstrated highly significant prevention of breast cancer
in animal models.
The technology is being developed at Cleveland Clinic with
funding from the U.S. Department of Defense. The funding is
expected to enable completion of two Phase 1 clinical
trials.
"This has the potential to be a paradigm-shifting clinical
study," said Dr. Tuohy. "If our data demonstrate results
similar to the pre-clinical studies, this vaccine could have a
significant impact on breast cancer, the most common malignancy in
women. Furthermore, the way we think about controlling breast
cancer may completely change."
"We look forward to moving this novel technology into the
clinical stage of development," stated Dr. Amit Kumar, President and CEO of Anixa
Biosciences. "If the data in humans is comparable to the data
in animals, Dr. Tuohy's 'retired' protein hypothesis will usher in
a new way to prevent breast cancer, as well as other types of
tumors."
"This initial clinical trial will be with women who have been
diagnosed with high-risk early stage TNBC and are receiving
standard of care at Cleveland Clinic," said Dr. G. Thomas Budd, Department of Medical Oncology at
the Taussig Cancer Center at Cleveland Clinic, and the Clinical
Investigator who will be conducting the trial. "We look
forward to commencing the Phase 1 clinical trial and evaluating
these 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 consists of a technology focused on
the immunization against α-Lactalbumin to prevent triple negative
breast cancer (TNBC). 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
release.
Investor contact:
Mike Catelani
mcatelani@anixa.com
408-708-9808
Media contact:
Sherry Ash
anixapress@gmail.com
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SOURCE Anixa Biosciences, Inc.