Announces focus on therapeutic approach;
resulting in a faster and more cost-effective path to
approval
SAN
JOSE, Calif., Sept. 24,
2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"
or the "Company") (NASDAQ: ANIX), a biotechnology company focused
on the treatment and prevention of cancer, today announced its
strategic plan for a Phase 2 study for its breast cancer vaccine.
The Phase 1 trial is being conducted at Cleveland Clinic, funded by
a grant from the U.S. Department of Defense.
The proposed Phase 2 trial will evaluate the efficacy of the
vaccine administered in the neoadjuvant (before surgery) setting,
in combination with chemotherapy and Keytruda (pembrolizumab). The
goal of neoadjuvant therapy is to reduce tumor burden and to
prevent tumor recurrence with the intent to improve survival. This
clinical trial approach allows Anixa to enroll a broader range of
patients, encompassing multiple types of breast cancer. The
therapeutic market for breast cancer is large due to the increase
in prevalence of breast cancer and an increase in screening
resulting in a demand for treatment. Compared with primary
prevention, the development path for breast cancer treatment is
expected to have a shorter path to approval. The therapeutic market
covers all stages of breast cancer, from early to advanced and
metastatic cases. In 2023, the market was valued at approximately
$38.35 billion and is projected to
reach $89.67 billion by 2030, growing
at a compound annual growth rate (CAGR) of 12.9% (Maximize Market
Research).
The key objectives of the trial include evaluating the
immunological response to the vaccine and comparing clinical
efficacy of standard of care therapy alone with the vaccine plus
standard of care therapy. A key component of this trial will be the
evaluation of breast cancer tissue and the validation of the
immunological mechanism of action of the vaccine.
The trial is expected to commence in 2025 and is projected to
last approximately two to three years. Immunological responses to
the vaccine will be made available as the trial advances, providing
a faster and more cost-effective path toward potential approval
and/or partnerships with pharmaceutical companies.
"We are excited to unveil our Phase 2 study plan, bringing us
one step closer to a potentially transformative therapy for breast
cancer patients," said Dr. Amit
Kumar, Chairman and CEO of Anixa Biosciences. "By targeting
treatment rather than prevention, we can reach a broader patient
population and potentially expedite the process of regulatory
approval and partnerships. This trial marks a key milestone in
advancing our mission to fight cancer through innovative therapies.
While our Phase 2 trial focuses on the therapeutic market, with the
data obtained in this trial, we expect to conduct additional, more
informed studies for both recurrence prevention and primary
prevention with partners in the future."
Initial Phase 1 data was presented at the San Antonio Breast
Cancer Symposium in December 2023.
The data showed no safety concerns, with protocol defined immune
responses observed in a majority of patients. Additional data from
the Phase 1 trial will be presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting in early November 2024.
The Phase 1 trial is conducted in collaboration with Cleveland
Clinic and is funded by a grant from the U.S. Department of
Defense. Anixa is the exclusive worldwide licensee of the novel
breast cancer vaccine technology developed at Cleveland Clinic. The
grant funding from the U.S. Department of Defense was provided to
Cleveland Clinic.
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 certain 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. Cleveland Clinic
exclusively licensed this 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.
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 vaccines being
developed in collaboration with Cleveland Clinic to prevent breast
cancer – specifically triple negative breast cancer (TNBC), the
most lethal form of the disease – and ovarian cancer, as well as
additional cancer vaccines to address many intractable cancers,
including high incidence malignancies in lung, colon, and prostate.
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 all stages of 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.