Amendment will allow a second dose of CAR-T
therapy to suitable patients
SAN
JOSE, Calif., Sept. 30,
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 it
and partner Moffitt Cancer Center ("Moffitt") have submitted an
amendment to the current protocol that governs its ongoing clinical
trial utilizing a CAR-T therapy to treat ovarian cancer
(NCT05316129).
A key change in the protocol provides a second dose of the
therapy to patients who might benefit from an additional dose.
Previously, Anixa and Moffitt sought and received approval of a
single patient IND application to enable a second dose for a single
patient who, upon examination of tumor obtained from a biopsy,
exhibited cellular infiltration and necrosis, indicating biologic
activity of the CAR-T. This amendment will permit all potential
patients to receive another leukapheresis and a second dose of
CAR-T, without submitting individual INDs for each patient.
Dr. Robert Wenham, Chair of the
Gynecologic Oncology Department at Moffitt, and the principal
investigator of the trial, stated, "In initial Phase 1 clinical
trials, it is customary to begin with low, often subtherapeutic
cell doses to verify safety, before increasing the dose levels. In
our study, the patient approved for a second dose by the individual
IND received the starting, lowest dose. While initially meeting the
criteria for progression due to size of her predominate tumor, her
cancer has since remained relatively stable and she has not
received additional therapy since her first infusion. We are hoping
a second, higher dose may improve her overall response and outcome.
In general, we anticipate that higher cell doses will lead to
efficacy, but for solid tumors, a second dose may be needed in a
subset of patients to improve the rate and durability of
responses."
"We hope to get approval from regulatory agencies shortly, to
enable second doses for the appropriate patients. We are clearly
enthusiastic about the progress of this trial and are looking
forward to treating additional patients," stated Dr. Amit Kumar, Chairman and CEO of Anixa
Biosciences.
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
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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.