SAN
JOSE, Calif., Feb. 26,
2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"
or the "Company") (NASDAQ: ANIX), a biotechnology company focused
on the treatment and prevention of cancer, today announced has it
has dosed its final patient in the third cohort of its ongoing
Phase 1 clinical trial evaluating its novel chimeric antigen
receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The
study is being conducted through a research partnership with
Moffitt Cancer Center ("Moffitt"). The fourth cohort is expected to
commence after a 30-day verification that there continue to be no
adverse effects experienced by the third cohort.
The third cohort in the trial received a dose of one million
CAR-positive cells per kilogram of patient weight, which represents
a tenfold increase compared to the first cohort. This escalation is
an important step in evaluating the safety and efficacy of CAR-T
therapy for ovarian cancer patients. The fourth cohort will
increase the dosage by another factor of three.
Anixa's FSHR-mediated CAR-T technology targets the
follicle-stimulating hormone receptor (FSHR), which research
indicates is exclusively expressed on ovarian cells, tumor
vasculature, and certain cancer cells. The first-in-human
trial (NCT05316129) is enrolling adult women with recurrent
ovarian cancer who have progressed after at least two prior
therapies. The study is designed to evaluate safety, identify
the maximum tolerated dose, and monitor efficacy.
Dr. Amit Kumar, Chairman and CEO
of Anixa, stated, "With the completion of the third cohort, we are
gaining important insights into the potential of CAR-T therapy for
ovarian cancer. Increasing the dose is a key step in evaluating the
therapy's effectiveness while ensuring patient safety.
Additionally, the recent approval of our protocol amendment allows
eligible patients to receive a second dose if they may benefit from
it. This amendment also expands enrollment criteria to include rare
ovarian cancer subtypes, making the therapy accessible to more
patients. Now, all eligible participants can receive a second dose
without requiring separate IND approvals, helping us better assess
the full potential of this treatment. As we move forward with the
fourth cohort, we remain committed to advancing our CAR-T program
with the goal of improving treatment options for ovarian cancer
patients."
About Anixa Biosciences, Inc.
Anixa is a
clinical-stage biotechnology company focused on the treatment and
prevention of cancer. Anixa's therapeutic portfolio consists of an
ovarian cancer immunotherapy program being developed in
collaboration with Moffitt Cancer Center, which uses a novel type
of CAR-T, known as chimeric endocrine receptor-T cell (CER-T)
technology. The Company's vaccine portfolio includes vaccines being
developed in collaboration with Cleveland Clinic to treat and
prevent breast cancer and ovarian cancer, as well as additional
cancer vaccines to address many intractable cancers, including high
incidence malignancies in lung, colon, and prostate. These vaccine
technologies focus on immunizing against "retired" proteins that
have been found to be expressed in certain forms of cancer. Anixa's
unique business model of partnering with world-renowned research
institutions on all stages of development allows the Company to
continually examine emerging technologies in complementary fields
for further development and commercialization. To learn more, visit
www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook
and YouTube.
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
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.
