SAN
JOSE, Calif., Aug. 28,
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 commenced
treatment of the third patient in the ongoing clinical trial of
Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for
ovarian cancer.
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.
The third patient received the same dose of engineered T-cells
as the first and second patients in the trial. Assuming safety is
validated in the third patient, as was the case for the first two
patients, Anixa expects to begin treatment of the second cohort in
the fourth quarter of 2023. Patients enrolled in this second cohort
will receive approximately three times the cell dose compared to
the first cohort.
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.
Dr. Robert Wenham, Principal
Investigator of the trial and Chair of the Gynecologic Oncology
Program at Moffitt Cancer Center, stated, "We are pleased that the
Phase 1 clinical trial evaluating this CAR-T therapy for ovarian
cancer continues to progress. We are looking forward to analyzing
the safety data from the first cohort, and look forward to
escalating the dose in the following cohort."
"Though enrollment of patients in this trial has been slow,
which is common for clinical studies of this type, we are pleased
to have completed the first cohort," stated, Dr. Amit Kumar, Chairman and CEO of Anixa
Biosciences. "Assuming there are no safety issues with this third
patient, we look forward to advancing to the next higher dose
cohort."
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.
About Moffitt Cancer Center
Moffitt is dedicated
to one lifesaving mission: to contribute to the prevention and cure
of cancer. The Tampa-based
facility is one of only 54 National Cancer Institute-designated
Comprehensive Cancer Centers, a distinction that recognizes
Moffitt's scientific excellence, multidisciplinary research, and
robust training and education. Moffitt's expert nursing staff is
recognized by the American Nurses Credentialing Center with Magnet®
status, its highest distinction. With more than 8,500 team members,
Moffitt has an economic impact in the state of $2.4 billion. For more information, call
1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the
momentum on Facebook, Twitter, Instagram 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.