– Antigen-specific T cell responses were
observed at all dose levels –
– IFNγ and IL-17, immune-mediated biomarkers
of T cell activation, increased over time from baseline –
– Vaccine was safe and well tolerated
–
– Conference call to commence today at
6:30 p.m. ET –
SAN
JOSE, Calif., Dec. 6, 2023
/PRNewswire/ -- Anixa Biosciences,
Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a
biotechnology company focused on the treatment and prevention of
cancer, today announced new and updated positive results from the
Phase 1 clinical trial of its breast cancer vaccine. The trial is
being conducted in collaboration with Cleveland Clinic with funding
by a grant from the U.S. Department of Defense.
The data were presented at the 2023 San Antonio Breast Cancer
Symposium by G. Thomas Budd, M.D.,
staff physician at Cleveland Clinic Cancer Institute and principal
investigator of the study, in a poster entitled "Phase I Trial of
alpha-lactalbumin vaccine in high-risk operable triple negative
breast cancer (TNBC) and patients at high genetic risk for
TNBC."
Patients who had been curatively treated for TNBC received three
vaccinations given once every two weeks. IFNγ and IL-17, which are
T cell immune response indicators (cellular immunity), and antibody
production (B cell humoral immunity) were measured to evaluate the
vaccination effect. Data from the 16 patients treated to date
showed that:
- The majority of patients developed ELISpot (T-cell) responses
that met the rigorous protocol-specified definition of an immune
response, with a measurable but lesser magnitude of response noted
in the remaining patients.
- 12 (75%) of the women had antigen-specific IFNγ and/or IL-17
ELISpot responses that were observed at all dose levels, while
ELISA antibody responses were observed at Dose Level 2 and
higher.
- A statistically significant (P = 0.03) increase in IFNγ over
baseline (Day 0) was observed by Day 56; while a significant (P =
0.0001) increase in IL-17 over baseline was observed by Day
14.
- Among the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10
mcg zymosan) was determined to be a usable immunologic dose as well
as the maximum tolerated dose (MTD).
- No significant side effects were observed, at the MTD, besides
irritation at the sites of injection. No myalgias, flu-like
symptoms, or aberrant laboratory values were noted.
Anixa and Cleveland Clinic plan to investigate additional
intermediate dose levels and continue studying the vaccine's safety
and immunologic effects in two additional patient cohorts.
- The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the
Company's breast cancer vaccine with Keytruda®
(pembrolizumab) in post-operative patients found to have residual
disease following neoadjuvant chemo-immunotherapy.
- The second cohort will investigate the safety and immunologic
effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2
mutation positive and are planning prophylactic risk-reducing
mastectomies.
"The data from our Phase 1 trial to date has exceeded our
expectations, and we are pleased with our progress. This vaccine is
designed to direct the immune system to destroy TNBC cancer cells
through a mechanism that has never previously been utilized for
cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa
Biosciences. "We look forward to reviewing additional data as the
trial continues to completion, and we are in the planning stages of
the Phase 2/3 studies of this vaccine. Our goal is to initially
evaluate the vaccine's ability to prevent recurrence of cancer in
survivors, and continue with extension studies to eventually
determine its effectiveness in preventing the initial onset of
TNBC."
"There is a large unmet need for preventing TNBC, an aggressive
form of breast cancer with few targeted treatment options
available," said Dr. Budd, Cleveland Clinic. "We are encouraged by
the data gathered to date and look forward to determining the
optimal vaccine dose in additional patient cohorts. Our hope is
that future studies will demonstrate that the antigen-specific T
cell responses we observed translate to the prevention of breast
cancer recurrence."
Anixa is the exclusive worldwide licensee to the novel breast
cancer vaccine technology invented at Cleveland Clinic, the site of
the Phase 1 trial. The grant from the U.S. Department of Defense
was made directly to Cleveland Clinic.
Conference Call Information
Anixa is pleased to invite all interested parties to participate
in a conference call, during which this new data will be
discussed.
Conference Call
Details:
|
Presentation
host:
|
Anixa management, with
special guest speakers
|
Date and
time:
|
Today, December 6,
2023, at 6:30 p.m. ET
|
Phone
access:
|
Registration
Link to receive your dial-in number and unique PIN
|
Webcast:
|
Available at
www.anixa.com under "Events & Presentations"
|
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. Dr. Tuohy was
inventor of the technology, which Cleveland Clinic exclusively
licensed to Anixa Biosciences. He 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 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.