This patient is expected to be the final
patient in the second dosage cohort of the trial
SAN
JOSE, Calif., June 24,
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 treated the sixth patient in the ongoing Phase 1 clinical trial
of its novel chimeric antigen receptor T-cell (CAR-T) therapy for
ovarian cancer. This patient is expected to be the last patient in
the second dosage cohort. If there continue to be no adverse
effects experienced by the second cohort participants, enrollment
of the third dosage cohort may commence within the next month. The
study is being conducted through a research partnership with
Moffitt Cancer Center.
Anixa's FSHR-mediated CAR-T technology, also known as chimeric
endocrine receptor T-cell (CER-T), differs from traditional CAR-T
therapy by targeting the follicle-stimulating hormone receptor
(FSHR), which research indicates is exclusively expressed on
ovarian cells, including the vasculature of tumors. The
first-in-human trial (NCT05316129) is enrolling female adult
patients with recurrent/progressing 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.
Safety was previously confirmed in the first three-patient
cohort. The fourth through sixth patients, enrolled in the
second cohort of the Phase 1 clinical trial, received triple the
dose of CAR-T cells compared with the dose of the first cohort,
with no dose-limiting toxicities observed.
Following the requisite wait time, of one month after dosing,
enabling confirmation that it is safe to escalate, the trial will
immediately begin enrolling patients in the third dose cohort,
which will be at a ten times higher dose than the initial
dosage.
Dr. Amit Kumar, Chairman and CEO
of Anixa Biosciences, stated, "We are highly encouraged by the
favorable safety profile observed thus far in both the first and
second patient cohorts, and are eager to evaluate a higher dose in
the next cohort. We are particularly encouraged by a notable
response in one of the patients in the first cohort, even though
the dosage was considered a subtherapeutic level. Our aim is to
maintain a positive safety profile as we escalate dosing, with the
goal of demonstrating additional objective evidence of efficacy.
Unlike conventional CAR-T cell therapies, which have achieved
amazing results in various hematological cancers, they have not
been effective in solid tumors. In contrast, we believe Anixa's
novel technology has the potential to make CAR-T effective in
ovarian cancer and perhaps across multiple solid tumor types. Our
unique and highly targeted CER-T approach targets the FSHR, which
is exclusively expressed on ovarian cells. A potential dual
mechanism of action is operating with our therapy targeting tumor
vasculature by starving or shrinking the tumor from the inside out,
as well as direct targeting of ovarian cells."
Dr. Kumar continued, "We believe that intraperitoneal (IP)
delivery may also be a significant advantage of our therapy, as it
allows direct trafficking of the CAR-T cells to the tumor sites,
which helps to minimize side effects such as cytokine release
syndrome (CRS). We believe this method of delivery not only
enhances the targeting of the tumor but also improves the overall
safety profile of the treatment. We expect that IP delivery may
enable us to use dosages that are much higher than possible with
intravenous delivery."
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 prevent breast
cancer – specifically triple negative breast cancer (TNBC), the
most lethal form of the disease – 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.