Advaxis Announces Dosing of First Patient with ADXS-NEO, an Investigational Customized Immunotherapy Approach Targeting Perso...
June 11 2018 - 8:00AM
Business Wire
-ADXS-NEO is being evaluated in a Phase 1
clinical trial in various cancers
-First patient dosed is being treated for
NSCLC
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, announced it has commenced a Phase 1
trial with the dosing of the first patient with ADXS-NEO, an
investigational personalized immunotherapy approach targeting
personal neoantigens found by sequencing a patient’s own cancer
cells. ADXS-NEO is being evaluated in an open-label,
dose-escalation, multicenter Phase 1 clinical trial in the United
States. The study is open to patients with metastatic non-small
cell lung cancer (NSCLC), metastatic microsatellite stable colon
cancer and metastatic squamous head and neck cancer. The first
patient dosed is being treated for non-small cell lung cancer.
ADXS-NEO is being developed in collaboration with Amgen. Advaxis is
leading clinical development through proof-of-concept.
Pre-clinical findings for ADXS-NEO were presented at the 2018
American Association for Cancer Research (AACR) Annual Meeting. The
company presented data in mouse models showing that ADXS-NEO
generates T cell responses against neoantigen peptides that control
tumor growth, even when they were identified as “non-immunogenic”
using a conventional peptide-adjuvant immunization. Additionally,
data were presented highlighting the capacity of the Advaxis Lm
vector and its ability to target frameshift mutations of greater
than 90 amino acids, and to generate T cells to multiple
neoantigens per frameshift in tumor mouse models.
“We are extremely pleased to advance ADXS-NEO into the clinic.
This program brings our clinically-validated Lm Technology to the
cutting-edge area of neoantigen immuno-oncology,” said Kenneth A.
Berlin, President and Chief Executive Officer of Advaxis. “We are
committed to realizing the potential of ADXS-NEO to mobilize
patients’ immune systems against mutations that accumulate within
and contribute to the development of their cancer, and to bring the
potential benefits of our technology to more patients and their
families.”
Enrolled patients will undergo a biopsy, and Advaxis will then
manufacture an investigational personalized treatment for each
patient based on an analysis of their tumor neoantigen mutations,
which will be ready to dose within 8 weeks of the initial biopsy.
More information about the trial is available at
www.clinicaltrials.gov.
About ADXS-NEO
ADXS-NEO is an investigational personalized Listeria
monocytogenes (Lm)-based immunotherapy designed to generate immune
response against mutation-derived tumor-specific neoantigens
identified through DNA sequencing of a patient’s own tumors. The
program focuses on creating a customized treatment for each patient
targeting multiple neoantigens found in a biopsy of the patient’s
tumor. ADXS-NEO is being developed in partnership with Amgen.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of proprietary
Lm-based antigen delivery products. These immunotherapies are based
on a platform technology that utilizes live attenuated Listeria
monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion
proteins. These Lm-based strains are believed to be a significant
advancement in immunotherapy as they integrate multiple functions
into a single immunotherapy and are designed to access and direct
antigen presenting cells to stimulate anti-tumor T cell immunity,
activate the immune system with the equivalent of multiple
adjuvants, and simultaneously reduce tumor protection in the tumor
microenvironment to enable the T cells to eliminate tumors. Advaxis
has product candidates in various stages of clinical and
preclinical development in the following areas: HPV-associated
cancers, neoantigen therapy, hotspot/cancer antigens and prostate
cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook, and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could
cause our actual results to differ materially include: our ability
to develop and commercialize the next generation of cancer
immunotherapies; the safety and efficacy of our proprietary
immunotherapies; the success and timing of our clinical trials,
including patient accrual; our ability to release the clinical hold
and reduce the impact to our trials; our ability to obtain and
maintain regulatory approval and/or reimbursement of our product
candidates for marketing; our plans to develop and commercialize
our products; our ability to successfully compete in the potential
markets for our product candidates, if commercialized; our ability
to obtain additional funding; the success and timing of our
preclinical studies including IND enabling studies; and our ability
to successfully implement our strategy. These forward-looking
statements are subject to a number of risks including the
forward-looking statements and risk factors set forth from time to
time in Advaxis’ SEC filings including, but not limited to, our
report on Form 10-K for the fiscal year ended October 31, 2017, and
on Form 10-Q for the quarter ended January 31, 2018, which are
available at www.sec.gov.
Any forward-looking statements set forth in this press release
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180611005241/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
212-838-3777mmiller@lhai.comorCompany:Advaxis, Inc.Ranya
Dajani, 609-250-7559Dajani@advaxis.com
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