Dose escalation for fourth patient follows
successful completion of first cohort
SAN
JOSE, Calif., Feb. 12,
2024 /PRNewswire/ -- Anixa Biosciences,
Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a
clinical-stage biotechnology company focused on the treatment and
prevention of cancer, today announced that treatment has commenced
for the fourth patient in the ongoing Phase 1 clinical trial of its
novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian
cancer. The study is being conducted through a research partnership
with Moffitt Cancer Center.
The first-in-human trial is enrolling patients with
recurrent/resistant ovarian cancer who have progressed on at least
two prior therapies. The CAR T was safe and tolerable in the first
three patients treated. The fourth patient, the first patient
enrolled in the second cohort, received triple the dose of CAR-T
cells compared with the dose of the first cohort. Anixa's Follicle
Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology, also
known as chimeric endocrine receptor T-cell (CER-T), differs from
traditional CAR-T therapy by targeting FSHR, which research
indicates is expressed on ovarian cells, as well as in the
vasculature of tumors.
Dr. Amit Kumar, Chairman and CEO
of Anixa, commented, "With no safety issues observed in the first
cohort of patients, we have successfully advanced to the next
cohort to evaluate a 3x higher dose. As the trial progresses, we
seek to demonstrate efficacy of our cell therapy in solid tumors—a
difficult challenge for traditional CAR-T therapies that have been
shown to be efficacious in hematological tumors and lymphoma."
Dr. Robert Wenham, the Principal
Investigator of the trial and the Chair of Gynecologic Oncology at
Moffitt, stated, "First, we have the advantage of a target that is
much more specific to our tumor tissue, which should minimize any
on-target, off-tumor effect. Additionally, we are administering the
engineered T-cells directly into the peritoneum (IP), which is the
location of most of the ovarian tumor lesions. We hope that this
delivery approach will enable direct trafficking of the CER-T-cells
to the tumor sites and minimize adverse events such as cytokine
release syndrome (CRS)".
About Anixa's CER-T Approach (Follicle Stimulating Hormone
Receptor-Mediated CAR-T technology)
Anixa's chimeric antigen
receptor T-cell (CAR-T) technology approach is an autologous cell
therapy 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 (chimeric endocrine)
receptor, and the target-binding domain is derived from its natural
ligand, this technology is known as CER-T (chimeric endocrine
receptor T-cell) therapy, a new type of CAR-T.
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 a novel
vaccine being developed in collaboration with Cleveland Clinic to
prevent breast cancer – specifically triple
negative breast cancer
(TNBC), the most lethal form of the disease –
as well as a vaccine to prevent ovarian cancer. 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 clinical 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.