SAN
JOSE, Calif., Aug. 7, 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 its
partner, Cleveland Clinic, has begun enrolling subjects in a
treatment arm evaluating the combination of the Company's breast
cancer vaccine with Keytruda® (pembrolizumab). An expansion of the
ongoing Phase 1 dose escalation trial of Anixa's breast cancer
vaccine, this treatment arm aims to determine if the
vaccine/Keytruda combination increases immune response.
Anixa's breast cancer vaccine is designed to generate T cells
that target triple negative breast cancer ("TNBC"). Keytruda,
a therapy marketed by Merck (NYSE: MRK), is approved for use with
chemotherapy before surgery and then alone after surgery to treat
both high-risk early-stage and advanced TNBC.
Keytruda is a type of immunotherapy known as a checkpoint
inhibitor. T cells, a type of white blood cell involved in the
body's immune system, have receptor proteins on their surface
called checkpoints. These checkpoints are utilized by other immune
cells to modulate the activity of T cells. Cancer cells, such
as TNBC cells, have developed mechanisms to target checkpoints
to inhibit the activity of T cells, as well as other immune cells.
This inhibition enables the cancer cells to escape destruction
by cytotoxic T cells. One of these key checkpoint receptors is
known as PD-1 (Programmed Cell Death Protein-1). TNBC, like
many other cancers, expresses a protein that binds to the PD-1
protein on T cells and essentially turns them "off." Keytruda is a
monoclonal antibody, which blocks the ability of the cancer cells
to inactivate T cells by shielding the PD-1 receptor.
Dr. Amit Kumar, Chairman and CEO
of Anixa stated, "Cleveland Clinic has demonstrated in both
preclinical and clinical studies that our breast cancer vaccine
induces an immune response–including, we believe, production of T
cells that can target TNBC–so we believe that the addition of
Keytruda could have a synergistic effect. If a vaccine induces the
creation of T cells targeting TNBC, and Keytruda generally
maintains T cell activity, the combination could be very potent. We
are grateful to the U.S. Department of Defense for providing the
funding for this new arm of the trial and look forward to Cleveland
Clinic's presentation of the updated data from this trial at the
San Antonio Breast Cancer Symposium (SABCS) in December."
About Anixa's Breast Cancer Vaccine Clinical Trial
The
Phase 1a study is designed to evaluate the safety of the vaccine,
identify the Maximum Tolerated Dose (MTD), and monitor the immune
response in vaccinated women. All participants in the Phase 1a
study are women who have had triple negative breast cancer (TNBC)
within the last three years and have been curatively treated having
undergone standard of care. At the time of vaccination, these
participants are tumor-free, as determined by standard diagnostic
techniques, but are at high risk of recurrence.
About Triple-Negative Breast Cancer
One in eight women
in the U.S. will be diagnosed with an invasive breast cancer at
some point in their lives. Approximately 10-15% of those diagnoses
are TNBC, however TNBC accounts for a disproportionately higher
percentage of breast cancer deaths and has a higher rate of
recurrence. This form of breast cancer is twice as likely to occur
in African-American women, and approximately 70% to 80% of the
breast tumors that occur in women with mutations in the BRCA1 genes
are triple-negative breast cancer.
About Anixa Bioscience's Breast Cancer Vaccine
Anixa's
breast cancer vaccine takes advantage of endogenously produced
proteins that have a function at certain times in life, but then
become "retired" and disappear from the body. One such protein is a
breast-specific lactation protein, α-lactalbumin, which is no
longer found post-lactation in normal, aging tissues, but is
present in the majority of triple-negative breast cancers.
Activating the immune system against this "retired" protein
provides preemptive immune protection against emerging breast
tumors that express α-lactalbumin. The vaccine also contains an
adjuvant that activates an innate immune response, which allows the
immune system to mount a response against emerging tumors to
prevent them from growing. This vaccine technology was invented by
the late Dr. Vincent Tuohy, who was the Mort and Iris November
Distinguished Chair in Innovative Breast Cancer Research in the
Department of Inflammation and Immunity at Cleveland Clinic's
Lerner Research Institute, and Cleveland Clinic exclusively
licensed the technology to Anixa Biosciences. Dr. Tuohy was
entitled to a portion of the commercialization revenues received by
Cleveland Clinic and also held equity in Anixa. The technology is
currently being tested in a Phase 1 clinical trial, conducted at
Cleveland Clinic and funded by a grant from the U.S. Department of
Defense to Cleveland Clinic.
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 that uses a novel type of
CAR-T known as chimeric endocrine receptor T-cell (CER-T)
technology, and is being developed in collaboration with Moffitt
Cancer Center. 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.