Third cohort dose is one million CAR positive
cells; ten times higher than the first cohort dose
SAN
JOSE, Calif., Nov. 18,
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 dosed its first patient in the third cohort in the ongoing
Phase 1 clinical trial of 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").
No dose limiting toxicity was observed in the initial
three-patient cohort or in the second three-patient cohort, in
which patients received a CAR-T cell dose triple that of the first
cohort. After the required one-month waiting period to assess the
occurrence of dose limiting toxicity and review of all safety data,
the trial has now dosed its first patient in the third cohort at a
tenfold increase over the initial dose.
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 on at least two prior therapies. The
study is designed to evaluate safety and identify the maximum
tolerated dose, while monitoring efficacy.
Dr. Robert Wenham, principal
investigator of the study and Chair of the Department of
Gynecologic Oncology at Moffitt, stated, "With no dose-limiting
safety issues observed in the first and second patient cohorts, we
have advanced to the next cohort to evaluate a 10x higher dose
compared with the starting dose. As the trial continues, our aim is
to demonstrate the tolerability of our CAR-T but we are optimistic
and hopeful about seeing efficacy in this solid tumor—a challenging
area for traditional CAR-T therapies, which have shown efficacy
mainly in hematologic tumors and lymphomas. We are very encouraged
how the trial has progressed and our observation in one patient
from the first cohort who had relative stability and even some mild
improvement for well over a year after her infusion. This is highly
unusual for a platinum resistant multiply treated ovarian cancer. A
tumor biopsy showed necrosis and T cell infiltration. Based on
these findings, we recently submitted an amendment to the trial
protocol to allow patients who may benefit from an additional dose.
Generally, we expect higher cell doses to increase efficacy,
although we also anticipate a second dose may further improve
response rates and durability. We are proud of the progress to date
and look forward to treating additional patients in the third
cohort."
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.
