Patient showed clinical activity after initial
treatment, with necrosis, inflammation, and T cell infiltration
observed in tumor biopsy from the lowest dose
SAN
JOSE, Calif., Oct. 15,
2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"
or the "Company") (NASDAQ: ANIX), a biotechnology company focused
on the treatment and prevention of cancer, today announced that it
has administered the second dose of its CAR-T therapy to an
individual patient. This follows a positive response after the
initial treatment in the ongoing Phase 1 clinical trial of its
chimeric antigen receptor T-cell (CAR-T) therapy for ovarian
cancer. The study is being conducted in collaboration
with Moffitt Cancer Center.
Previously, Anixa and Moffitt received approval for a
single-patient IND application, allowing the administration of a
second dose to a patient whose tumor biopsy revealed cellular
infiltration and necrosis, indicating biological activity of the
CAR-T therapy.
After the first infusion, the patient remained stable, did not
require alternative treatment and her quality of life was good,
leading to the decision to administer a second dose to further
enhance these positive results. These findings offer promising
indications that the CAR-T therapy may serve as a successful
long-term treatment option, highlighting its potential
effectiveness in the fight against ovarian cancer.
"While this is a single patient, the positive clinical activity
observed, including necrosis and T cell infiltration, is an
encouraging sign of the therapy's potential effectiveness," stated
Dr. Robert Wenham, Chair of the
Department of Gynecologic Oncology at Moffitt and the principal
investigator of the trial. "Based on these results, we recently
submitted an amendment to the current trial protocol to allow
patients who may benefit to receive a second dose. We are excited
to continue evaluating this treatment in our ongoing trial, and we
are optimistic about the potential long-term benefits it may offer
to patients with ovarian cancer."
Dr. Monica Avila, the patient's
treating oncologist, stated, "My patient received her first
infusion in May 2023. We are now
nearly 18 months from that date, and she is doing well and is now
receiving this second dose. I am thrilled with her status and look
forward to observing further progress."
Dr. Amit Kumar, CEO of Anixa
Biosciences, stated, "We are proud to have an outstanding team,
including Dr. Wenham and Dr. Avila, and we are encouraged by the
positive response seen in this patient following the initial dose
of our CAR-T therapy. The continued clinical improvements reinforce
our confidence in the potential of this groundbreaking treatment to
provide hope for patients battling ovarian cancer. We remain
committed to advancing this innovative therapy and bringing new,
effective treatment options to the forefront."
The Phase 1 clinical trial at Moffitt is treating recurrent
ovarian cancer patients who have failed standard-of-care therapies.
To date, six patients have been treated in the dose escalation
trial, three in the first cohort and three in the second cohort.
Dose escalation will continue after confirming the previous dosages
are safe.
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.