- Data continues positive trend as additional patients are
enrolled in 3 cohorts
- Vaccine was safe and well tolerated by participants in all 3
cohorts
- Protocol defined immune responses were exhibited in over 70%
of patients
- A Phase 2 study evaluating the vaccine in the neoadjuvant
setting is planned to commence in 2025
SAN
JOSE, Calif., Nov. 8, 2024
/PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company")
(NASDAQ: ANIX), a biotechnology company focused on the treatment
and prevention of cancer, today announced a presentation of new,
updated positive data from the Phase 1 clinical trial of its breast
cancer vaccine (NCT04674306) at the Society for Immunotherapy of
Cancer (SITC) 39th Annual Meeting, being held in Houston, Texas. The trial is being conducted
in collaboration with Cleveland Clinic with funding by a grant from
the U.S. Department of Defense. The presentation, titled "Phase I
Trial of alpha-lactalbumin vaccine in high-risk operable triple
negative breast cancer (TNBC) and patients at high genetic risk for
TNBC," was presented by Dr. Emily
Rhoades, FDA/IND Trial Program Manager at Cleveland
Clinic.
"Triple negative breast cancer is the form of the disease for
which we have the least effective treatments," said G. Thomas Budd, M.D. of Cleveland Clinic's Cancer
Institute and principal investigator of the Phase 1 study. "Long
term, we are hoping that this can be a true preventive vaccine that
would be administered to individuals who are cancer-free to prevent
them from developing this highly aggressive disease."
"We are pleased with the data we have observed in this clinical
trial. The data continues to exceed our expectations. As we near
completion of the Phase 1 trial, with the very positive data to
date, we are planning a Phase 2 study which is expected to commence
in 2025," stated Dr. Amit Kumar,
Chairman and CEO of Anixa Biosciences. "We want to thank all of the
participants in this trial and also the extensive group of
scientists and physicians (19 are listed as co-authors of the SITC
presentation) who have worked on this study, along with the
numerous additional personnel including nurses, pharmacists,
phlebotomists and others who have provided support."
The investigational vaccine is based on decades of
groundbreaking pre-clinical research led by the late Vincent Tuohy, Ph.D., who was the Mort and Iris
November Distinguished Chair in Innovative Breast Cancer Research
at Cleveland Clinic's Lerner Research Institute. Dr. Tuohy's
research led to the development of this investigational
vaccine. The study is based on Dr. Tuohy's research that
showed that activating the immune system against α-lactalbumin was
safe and effective in preventing breast tumors in mice. The
research, originally published in Nature Medicine, was
funded in part by philanthropic gifts to Cleveland Clinic from more
than 20,000 people over the last 12 years.
The vaccine was developed at Cleveland Clinic and licensed to
Anixa Biosciences. Cleveland Clinic is entitled to royalties and
other commercialization revenues from the Company.
"It was Dr. Tuohy's hope that this vaccine would demonstrate the
potential of immunization as a new way to control breast cancer,
and that a similar approach could someday be applied to other types
of malignancy," said Dr. Budd.
Description of the Breast Cancer Vaccine
The vaccine targets a lactation protein, α-lactalbumin, which is
only expressed in the breast when a woman is lactating but not at
other times in her life or in other tissues. However, when a woman
develops breast cancer, including TNBC or other types of breast
cancer, many of the malignant cells will express α-lactalbumin.
Activating the immune system, through vaccination, to direct
cytotoxic T cells to the tumor cell expressing this protein may
provide preemptive immune protection against emerging breast tumors
that express α-lactalbumin.
Initial Phase 1 data was presented at the San Antonio Breast
Cancer Symposium in December 2023.
The synopsis below summarizes the additional findings which were
presented today at the SITC 39th Annual Meeting.
Presentation Summary
The trial is recruiting patients into three cohorts. Below is a
description of each cohort as well as a summary of the key results
and conclusions to date.
Cohort 1a participants: The patients enrolled are
women who, within the previous three years, have completed standard
of care (SOC) treatment, including surgery, for TNBC, the most
lethal type of breast cancer. The study is evaluating the safety
and tolerability of the vaccine, characterizing immune responses,
and identifying a maximum tolerated dose (MTD).
Key Results: All three goals noted above have been
achieved, in a group of 21 patients in this cohort. While the MTD
has been successfully identified, additional dosages are being
evaluated to confirm the MTD. In all patients at the current MTD,
the vaccine was safe, producing no flu-like symptoms such as fever
and myalgias, no abnormal clinical laboratory tests, or other
observed adverse side effects. The only notable side effect was
injection site irritation. The majority of patients exhibited
protocol defined immune responses of α-lactalbumin specific T cell
induced interferon gamma and interleukin-17.
Cohort 1b
participants: The patients enrolled are women who carry
mutations in their BRCA1, BRCA2, or PALB2 genes that place them at
high risk of developing breast cancer, which is frequently TNBC.
These women have chosen to have prophylactic mastectomies to reduce
their risk of breast cancer. These participants were vaccinated
prior to their surgeries, after which they were monitored for
safety and immune responses. Immunohistochemistry (IHC) analysis
will be performed on their resected breast tissue to evaluate their
healthy breast tissue to determine if there are micro-foci of
lactational cells, inflammation in the area of those foci and the
presence of micro-tumors.
Key Results: Three women have been enrolled in this
cohort to date. The safety and tolerability of the vaccine were
similar to that in Cohort 1a. Enrollment of additional patients in
this cohort is ongoing. The IHC analysis is ongoing and will be
presented in a future scientific presentation.
Cohort 1c participants: The patients enrolled in this
group are women diagnosed with TNBC who have completed SOC,
including surgery, and are receiving pembrolizumab (Keytruda) in
the adjuvant, post-surgery setting. Since Keytruda, a checkpoint
inhibitor, is already a powerful immunotherapy with its own side
effect profile, one of the primary goals of this cohort is to
evaluate whether the administration of the vaccine in combination
with Keytruda causes intolerable side effects. Immune responses are
also being monitored in these participants.
Key Results: Three women have been enrolled in this
cohort to date. Most notably, there were no major adverse side
effects when the combination of vaccine and Keytruda were
administered. As with the patients in cohorts 1a and 1b, the primary adverse side effect was injection
site irritation. One patient exhibited a Grade 3 adverse event,
which was a greater amount of irritation at one injection site.
This patient had been diagnosed with breast cancer while she was
pregnant, and she had recently lactated when the vaccine was
administered. The trial protocol is being amended to provide for a
six-month delay after lactation before a patient can be vaccinated.
Similar to the patients enrolled in cohort 1a, the participants in
this trial also exhibited antigen-specific T cell immune responses
as hoped. Now that antigen-specific T cell responses have been
confirmed in women receiving Keytruda and the vaccine, with no
major side effects, the data provide the confidence to plan a Phase
2 study in the neoadjuvant setting with newly diagnosed breast
cancer patients.
"Since the trial results to date have been very positive, the
planned Phase 2 trial will enroll newly diagnosed breast cancer
patients undergoing neoadjuvant treatment. Patients will be
randomized in a one-to-one ratio, to receive either the standard of
care, as defined by NCCN guidelines, alone or the vaccine plus
standard of care. The important endpoints in this study will
include characterization of T and B cell immune responses and
repertoires, pathologic complete response and safety. Utilizing the
vaccine in this type of setting will enable us to determine the
effect within months for individual patients. The presence of a
control group will allow us to determine efficacy in this setting.
Assuming the trial data continues to be positive, such a trial may
enable a quicker route to a strategic relationship with a large
pharmaceutical partner for commercialization," stated Dr.
Kumar.
The poster presented at SITC can be viewed at
https://ir.anixa.com/events.
For more information and eligibility requirements visit
clinicaltrials.gov.
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 treat and
prevent breast cancer 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.