- With no dose-limiting toxicities observed,
treatment of second dose cohort to begin
SAN
JOSE, Calif., Oct. 13,
2023 /PRNewswire/ -- Anixa Biosciences,
Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a
biotechnology company focused on the treatment and prevention of
cancer, today announced that, in partnership with Moffitt Cancer
Center, it has completed treatment of the first patient cohort in
the ongoing clinical trial of Anixa's novel chimeric antigen
receptor T-cell (CAR-T) therapy for ovarian cancer.
All three patients in the first cohort received the same dose of
engineered T-cells, with no dose-limiting toxicities observed.
Following the requisite wait time after the last patient was dosed,
a comprehensive review of the safety data from this cohort, and
confirmation that it is safe to escalate, the trial will begin
enrolling patients in the second dose cohort immediately. Patients
enrolled in this second cohort will receive three times the cell
dose compared to the first cohort.
Dr. Amit Kumar, Chairman and CEO
of Anixa Biosciences, stated, "We are pleased with the positive
safety data from the first cohort and look forward to advancing to
the next higher dose cohort. We hope to continue observing good
safety results as we continue to increase dosage, and eventually
objective efficacy data."
The study (NCT05316129), which is being conducted at Moffitt
Cancer Center, is a dose-escalation Phase 1 trial to evaluate the
therapy's safety; determine the maximum tolerated dose of T-cells
targeting the follicle stimulating hormone receptor (FSHR); and
preliminarily assess clinical activity. All patients being enrolled
in the trial have disease that is progressing and have failed at
least two, but often more, therapeutic interventions.
Dr. Robert Wenham, the Principal
Investigator of the trial, and the Head of Gynecological Oncology
at Moffitt stated, "We are very pleased with the results to date.
The first three patients were dosed through a peritoneal
catheter and no patient has had a dose-limiting
toxicity. Since most lesions in ovarian cancer are within
the peritoneum, we hope the delivered CAR-T cells remain localized
and active in the vicinity of the tumors. It's possible that we may
see very limited side effects due to this local, as opposed to
systemic, delivery. The very selective target also gives
us reason to hope that on-target, off-tumor effects will not be
prevalent as in other solid tumor studies. Perhaps this
delivery approach may enhance efficacy as well. However, we will
also test this therapy by intravenous administration, in patients
for whom peritoneal administration is not possible."
The CAR-T approach used for Anixa's therapy is known as chimeric
endocrine receptor T-cell (CER-T) since the target of the
engineered T-cells is an endocrine receptor. While CAR-T therapy
has shown efficacy in some hematological tumors, reproducing the
same results with solid tumors, such as ovarian cancer, has proven
challenging. One of the reasons for this difficulty is that
effective CAR-T therapy needs to attack a specific antigen present
only on targeted cells to avoid negatively affecting healthy cells.
The cell therapy being evaluated in Anixa's Phase 1 study differs
from traditional CAR-T therapy in that it targets the FSHR, which
research indicates is exclusively expressed on ovarian cells in
healthy adult females.
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.
Contacts:
Stephen
Kilmer
Investor Relations
skilmer@anixa.com
646-274-3580
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.