IND follows encouraging findings of necrosis,
inflammation and T cell infiltration in tumor biopsy of
patient in lowest dose cohort
SAN
JOSE, Calif., July 23,
2024 /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
collaborator, Moffitt Cancer Center (Moffitt), has received
approval by the U.S. Food and Drug Administration (FDA) of an
individual patient Investigational New Drug Application (IND) to
allow a second dose of its CAR-T therapy for a patient that may be
demonstrating clinical activity to the initial treatment.
Dr. Robert Wenham, Chair,
Department of Gynecologic Oncology at Moffitt, and the principal
investigator of the trial, stated, "In the first cohort and at the
lowest dose administered, despite an initial increase in tumor size
that met criteria for progression, one patient has remained off new
therapy for many months with no new disease. Even her tumor marker
that was initially elevating later began to fall. A biopsy
demonstrated tumor with necrosis, inflammation and T cell
infiltration by Immunohistochemistry (IHC). Based on these
findings, we sought approval from the FDA to administer a second
treatment to her, aiming to increase the likelihood of a partial or
complete response. Recently, we received that approval from the
FDA."
"I am pleased with the very long duration absent of any further
disease and the possible response that my patient has exhibited
with this innovative therapy, as she had no other realistic
options. I look forward to evaluating her progress with successive
dosing, as well as future patients who have no other alternatives,"
stated Dr. Monica Avila, the
patient's treating oncologist.
Dr. Amit Kumar, CEO of Anixa
Biosciences commented, "We were somewhat surprised and quite
encouraged to see such a notable response this early, given the low
dose in the first cohort. We truly hope we can help this patient,
as well as all other women fighting this terrible disease."
The Phase I clinical trial at Moffitt is treating recurrent
ovarian cancer patients who have failed standard-of-care therapies.
To date, six patients have been treated in the dose escalation
trial, three in the first cohort and three in the second cohort.
Dose escalation will continue after confirming the previous dosages
are safe.
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-announces-fda-approval-of-individual-patient-ind-for-its-ovarian-cancer-car-t-therapy-302203383.html
SOURCE Anixa Biosciences, Inc.