Advaxis Announces FDA Acceptance of IND for Groundbreaking Personalized Neoepitope Immunotherapy, ADXS-NEO
March 06 2017 - 6:00AM
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company
developing cancer immunotherapies, today announced that the U.S.
Food and Drug Administration (FDA) has indicated the
Investigational New Drug (IND) application for ADXS-NEO, a
personalized neoantigen-targeted approach to cancer immunotherapy
that is being developed in collaboration with Amgen, can proceed.
This ground-breaking IND paves the way for
bringing a new precision immunotherapy for the treatment of cancers
into the clinic this year. ADXS-NEO employs Advaxis’ proprietary
Listeria monocytogenes (Lm)-based antigen delivery technology, its
Lm Technology™, to target multiple patient-specific neoantigens in
each individual patient’s tumor that are not present in normal
cells. ADXS-NEO is designed to stimulate both the innate and
adaptive arms of the immune system.
Advaxis bioengineers ADXS-NEO constructs by
programming its Lm-based antigen delivery technology to present the
unique protein fragments or neoantigens associated with mutations
found in a patient’s own cancer cells. These cancer-specific
mutations are identified by comparing the DNA sequences of cancer
cells with normal cells. ADXS-NEO works by presenting a large
payload of neoantigens directly into dendritic cells within the
patient’s immune system to generate new cancer-fighting white blood
cells. These T cells hunt down cancer cells bearing these
neoantigens while at the same time broadly stimulating the immune
system and reducing the ability of the cancer to resist.
ADXS-NEO constructs can present multiple
neoantigens that can be targeted by a patient’s immune system
simultaneously. Tumors may accumulate up to 100 or more mutations
that can generate neoantigens, and each patient has a set of
mutations that are unique to his or her own tumors. ADXS-NEO is
designed to hit multiple targets at once to improve the likelihood
of a benefit.
ADXS-NEO will be manufactured in Advaxis’ newly
constructed facility in Princeton, N.J., utilizing a process that
minimizes the time required to develop the patient-specific
immunotherapy. A single manufacturing run can provide sufficient
product to treat each patient repeatedly for more than one
year.
“The IND acceptance is a landmark step towards
escaping the one-size-fits-all approach to cancer treatments by
building innovative, patient-specific immunotherapies. This highly
personalized approach has the potential to transform the treatment
of care across multiple types of cancers,” said Robert Petit,
Ph.D., Chief Scientific Officer of Advaxis. “This enables us to
employ Lm Technology to focus the attention of a patient’s immune
system against the very mutations within their cancer that turned
their cells malignant in the first place.”
ADXS-NEO is under development through a
collaboration between Amgen and Advaxis, bringing together Amgen’s
expertise in immuno-oncology development and commercialization and
Advaxis’ proprietary Lm-based antigen delivery technology and it’s
My Immunotherapy Neo-Epitopes or MINE™ platform. Advaxis plans to
initiate a phase 1 trial evaluating ADXS-NEO in multiple tumor
types later this year.
“Over the past several years, the field of
cancer immunotherapy has brought promising new treatments with
meaningful benefits to cancer patients. Amgen remains
committed to a multi-modality approach in immunotherapy, and our
collaboration with Advaxis adds to the toolkit of cancer-fighting
options available for patients,” said David M. Reese, Senior Vice
President, Translational Sciences at Amgen. “We look forward to our
continued work with Advaxis to explore the potential of ADXS-NEO in
the clinic and across multiple tumor types.”
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
clinical-stage biotechnology company developing multiple cancer
immunotherapies based on its proprietary Lm Technology.
The Lm Technology, using bioengineered live
attenuated Lm bacteria, is the only known cancer immunotherapy
agent shown in preclinical studies to both generate cancer fighting
T cells directed against cancer antigens and neutralize Tregs and
myeloid-derived suppressor cells (MDSCs) that protect the tumor
microenvironment from immunologic attack and contribute to tumor
growth. Advaxis' lead Lm Technology immunotherapy,
axalimogene filolisbac, targets HPV-associated cancers and is in
clinical trials for three potential indications: Phase 3 in
invasive cervical cancer, Phase 2 in head and neck cancer, and
Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac
orphan drug designation for each of these three clinical settings,
as well as Fast Track designation for adjuvant therapy for high
risk locally advanced cervical cancer (HRLACC) patients and a SPA
for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene
filolisbac has also been classified as an advanced therapy
medicinal product for the treatment of cervical cancer by the EMA’s
CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in
prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in
human clinical development. In addition, Advaxis and Amgen are
developing ADXS-NEO, a preclinical investigational cancer
immunotherapy treatment designed to activate a patient's immune
system to respond against the unique mutations, or neoepitopes,
contained in and identified from each individual patient's tumor,
with plans to enter the clinic in 2017.
To learn more about Advaxis, visit
www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and
YouTube.
Advaxis Forward-Looking Statement
This press release contains forward-looking
statements, including, but not limited to, statements regarding
Advaxis’ ability to develop the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapy, axalimogene filolisbac. These
forward-looking statements are subject to a number of risks
including the risk factors set forth from time to time in Advaxis’
SEC filings including, but not limited to, its report on Form 10-K
for the fiscal year ended October 31, 2016, which is available at
http://www.sec.gov.
Any forward-looking statements set forth in this
presentation speak only as of the date of this presentation. We do
not intend to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof
other than as required by law.
You are cautioned not to place undue reliance on
any forward-looking statements.
CONTACTS:
Company:
Advaxis, Inc. Ranya Dajani, Vice President, Business Development
dajani@advaxis.com 609.250.7559
Media Contact:
JPA Health Communications David Connolly dconnolly@jpa.com
617.945.9316
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