Advaxis Announces FDA Allowance of IND Application for ADXS-HOT Drug Candidate for Non-Small Cell Lung Cancer
July 30 2018 - 8:00AM
Business Wire
Selects Bladder Cancer as Third ADXS-HOT
Drug Candidate to Take into the Clinic after Non-Small Cell Lung
and Prostate Cancers
Advances Goal to Have Five Neoantigen-Based
Drug Candidates in Clinical Evaluation by 4Q 2019
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announced that the U.S. Food and
Drug Administration (FDA) has allowed the Company’s IND application
for its ADXS-HOT drug candidate for non-small cell lung cancer
(NSCLC). Advaxis anticipates that because of this timely allowance,
the first patient in the Phase 1/2 trial for this NSCLC drug
candidate will be dosed by the end of 2018.
ADXS-HOT is a cancer-type specific immunotherapy approach that
leverages the Company’s proprietary Lm technology platform to
target hotspot mutations that commonly occur in specific cancer
types as well as other proprietary tumor-associated antigens. To
date, more than 10 drug candidates have been designed for different
tumor types in the ADXS-HOT program.
“This is an exciting time for Advaxis as we prepare to initiate
the first clinical trial with a drug candidate from our ADXS-HOT
program. This drug candidate, ADXS-503, has been designed for the
treatment of patients with NSCLC,” said Kenneth A. Berlin,
President and Chief Executive Officer of Advaxis. “With our
increased strategic focus on neoantigen-based therapeutics,
including the personalized, patient-specific approach of our
ADXS-NEO program, already in a clinical trial, we anticipate having
five neoantigen-based drug candidates in clinical evaluation by the
end of 2019. Our next two ADXS-HOT drug candidates will focus on
prostate and bladder cancers. These two tumor types, along with
NSCLC, were prioritized based on our evaluation of a number of
factors relating to each, including the unmet medical need, time
and investment required to demonstrate meaningful clinical activity
and immunological sensitivity,” concluded Mr. Berlin.
The Company plans to initiate a Phase 1/2 clinical trial that
will seek to establish the safety, tolerability and effectiveness
of ADXS-503 administered alone and in combination with a checkpoint
inhibitor in approximately 50 patients with metastatic NSCLC in
different lines of therapy, at up to 20 centers across the U.S.
“I am pleased we can move forward to advance our first trial
with ADXS-503, the first drug candidate in our ADXS-HOT program.
This is an important clinical milestone as we seek to demonstrate
proof-of-concept for ADXS-HOT immunotherapy in NSCLC, where there
remains significant unmet need despite the introduction of
checkpoint inhibitors and targeted therapies,” said Andres
Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice
President of Advaxis. “Earlier drug candidates from our Lm platform
expressing a single antigen have shown a favorable safety profile
and preliminary clinical activity in more than 500 subjects treated
to date across different tumor types. This clinical experience with
prior Lm drug candidates, combined with our ability to leverage the
large capacity of our Lm vector to express multiple neoantigens and
other tumor-associated antigens, provides the foundation for our
belief that ADXS-HOT drug candidates such as ADXS-503 for NSCLC can
provide a new standard for off-the-shelf neoantigen vaccines.”
Advaxis affirms plans to submit a total of four INDs for drug
candidates from its ADXS-HOT program by the fourth quarter of 2019.
Beyond NSCLC, prostate cancer and bladder cancer, the fourth
ADXS-HOT drug candidate will be selected from breast, colorectal,
ovarian or head and neck cancers.
About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary
Lm technology to target hotspot mutations that commonly occur in
specific cancer types. ADXS-HOT drug candidates are designed to
target acquired shared or “public” mutations in tumor driver genes
along with other cancer-testes and oncofetal tumor-associated
antigens that also commonly occur in specific cancer types.
Although ADXS-HOT drug candidates have not yet been tested in
patients, they are an off-the-shelf treatment approach been
designed to potentially treat all patients with a specific cancer
type, without the need for pretreatment biomarker testing, biopsy,
DNA sequencing or diagnostic testing.
About ADXS-NEO
ADXS-NEO is an investigational personalized 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 four franchises in various stages of clinical and preclinical
development: 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: 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
ability to obtain the appropriate labeling of our products under
any regulatory approval; our plans to develop and commercialize our
products; the successful development and implementation of our
sales and marketing campaigns; the size and growth of the potential
markets for our product candidates and our ability to serve those
markets; our ability to successfully compete in the potential
markets for our product candidates, if commercialized; regulatory
developments in the United States and other countries; the rate and
degree of market acceptance of any of our product candidates; new
products, product candidates or new uses for existing products or
technologies introduced or announced by our competitors and the
timing of these introductions or announcements; market conditions
in the pharmaceutical and biotechnology sectors; our available
cash; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing;
our ability to obtain additional funding; our ability to obtain and
maintain intellectual property protection for our product
candidates; the success and timing of our preclinical studies
including IND-enabling studies; the timing of our IND submissions,
the ability of our product candidates to successfully perform in
clinical trials; our ability to execute clinical trials; our
ability to maintain collaborations; our ability to initiate pilot
studies and clinical trials, enroll our trials, obtain and maintain
approval of our product candidates; our ability to manufacture and
the performance of third-party manufacturers; the performance of
our clinical research organizations, clinical trial sponsors and
clinical trial investigators; our ability to successfully implement
our strategy; and other risk factors identified from time to time
in our reports filed with the SEC. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not intend to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180730005190/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
212-838-3777mmiller@lhai.comorAdvaxis, Inc.Ranya Dajani,
609-250-7559dajani@advaxis.com
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ayala Pharmaceuticals (QX) (USOTC:ADXS)
Historical Stock Chart
From Apr 2023 to Apr 2024