SAN JOSE, Calif., Aug. 30, 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 (FDA) has cleared the Investigational New Drug (IND)
application for its CAR-T (Chimeric Antigen Receptor-T cell)
therapy, which is being developed in partnership with Moffitt
Cancer Center (Moffitt).
- Dr. Robert Wenham, Chair of
Gynecological Oncology at Moffitt will lead the clinical
trial.
- This CAR-T therapy was developed by Dr. Jose Conejo-Garcia and his research team, when
he was at the Wistar Institute. Dr. Conejo-Garcia is currently
the Chairman of Immunology at Moffitt.
- Anixa Biosciences has an exclusive worldwide license to the
technology.
- This technology is an autologous cell therapy. The therapeutic
product is comprised of engineered T-cells that target the follicle
stimulating hormone receptor (FSHR). FSHR is found at
immunologically relevant levels exclusively on the granulosa cells
of the ovaries. Since the target is a hormone receptor, and the
target-binding domain is derived from its natural ligand, 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 stated, "We are pleased that the FDA has authorized us to
commence human clinical trials of our potentially paradigm-shifting
therapy. Outcomes for women with late-stage ovarian cancer are
poor, so if this approach demonstrates efficacy, it would have a
dramatic impact on patients for whom there are no other
options."
"This is a major milestone for our program. CAR-T therapy has
had major successes in B-cell malignancies, but no clinical success
in other types of tumors. We feel that our technology could be the
first CAR-T approach that will demonstrate efficacy in a solid
tumor indication, and we are looking forward to testing and
verifying that assertion in human trials," said Dr. Wenham.
In addition to Drs. Wenham and Conejo-Garcia, other key members
of the team at Moffitt include:
- Dr. Marco Davila, Clinician and
Director of the Cell Therapy Facility at Moffitt
- Dr. Daniel Abate Daga, Assistant
Director of the Cell Therapy Facility at Moffitt
- Dr. Ana Marie Landin,
Experimental Cell Therapy Manager at Moffitt
- Dr. Theresa Boyle, Department of
Pathology at Moffitt
- Carrie Thomas, FDA Regulatory
Liaison at Moffitt
- Tam Jackson, Project Management
Consultant
- Scientists and Members of the Moffitt Cell Therapy
Facility
- Members of the Moffitt Alliance Relations Team
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.