SAN JOSE, Calif., May 20, 2021 /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 (US FDA)
has provided details of the additional information it is requesting
regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T)
being developed in partnership with Moffitt Cancer Center.
The Investigational New Drug (IND) application for this study
was submitted in March, and the US FDA subsequently requested
additional information before approving the trial. The
details of that information request have now been provided by the
FDA. Anixa and Moffitt feel that the requested information
can be assembled and provided to the FDA within approximately 30
days, after which the FDA will again respond within 30 days after
the submission.
This technology is an autologous cell therapy that requires the
manufacture of a unique drug product for each individual patient.
The therapeutic product is comprised of engineered T-cells
that target the follicle stimulating hormone receptor (FSHR).
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. Amit Kumar, President and CEO
of Anixa Biosciences, stated, "We are pleased to receive this
letter with the detailed information request. While we hope
to comply with the request within 30 days, certain assays may
require additional time for validation before submission. We
will strive to file our submission as soon as possible and we will
seek to initiate this clinical trial before the end of the
year."
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, 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.
Contact:
Mike Catelani
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.