SAN
JOSE, Calif., May 22, 2023
/PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a
biotechnology company focused on the treatment and prevention of
cancer, today announced that, in conjunction with its partner
Moffitt Cancer Center, it has commenced treatment of the second
patient in the ongoing clinical trial of its novel chimeric antigen
receptor T-cell (CAR-T) therapy for ovarian cancer.
This study (NCT05316129) is a dose-escalation Phase 1 trial to
evaluate safety and to determine the maximum tolerated dose of
follicle stimulating hormone receptor T-cells and to preliminarily
assess clinical activity. The study is being conducted at Moffitt
Cancer Center. All patients being enrolled in the trial have
disease that is progressing and have failed at least two, but often
more, therapeutic interventions. This patient received the same
dose of engineered T-cells as the first patient in the trial, and
the next (third) patient is expected to also receive the same dose.
The successive three-patient cohort is expected to receive a higher
dose of cells.
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 a specific antigen to recognize that
is only present on target cancer cells in order to avoid negatively
affecting healthy cells. The cell therapy being evaluated in
Anixa's Phase 1 study differs from traditional CAR-T in that it
targets the follicle stimulating hormone receptor (FSHR), which
research indicates is exclusively expressed on ovarian cells in
healthy adult females.
"We are optimistic about the potential of this therapy to impact
ovarian cancer patients who are out of all other options. Our goal
is to increase enrollment at a responsible rate that enables us to
understand the impact that our therapy is exhibiting," stated Dr.
Robert Wenham, the principal
investigator of this trial at Moffitt Cancer Center.
"We are pleased to have treated the second patient in our
ovarian cancer CAR-T clinical study," stated Dr. Amit Kumar, Chairman and CEO of Anixa
Biosciences. "We anticipate an increase in the rate of patient
recruitment, and expect the third and potentially last patient of
the current dose cohort to be treated soon. Since this is the early
stage of patient enrollment, we are announcing publicly the
treatment of the second patient, but it is not our intent to
announce enrollment of each subsequent patient. We will make
periodic announcements when warranted."
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
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.