Accueil / Communiqués / Advaxis Presents an Overview of its Lm Platform and Neoantigen-Directed Programs at the Immuno-Oncology 360° Conference

Advaxis Presents an Overview of its Lm Platform and Neoantigen-Directed Programs at the Immuno-Oncology 360° Conference

Wednesday, February 6th 2019 at 1:30pm UTC

PRINCETON, N.J.–(BUSINESS WIRE)– Advaxis,
Inc.
 (NASDAQ:ADXS), (the Company) a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, announces the presentation of the progression of
its Lm platform from discovery to clinical application, and the
unique opportunity the platform affords Advaxis in its pursuit of
innovative new cancer therapeutics.

The presentation is being made today by Robert G. Petit, Ph.D., the
Company’s Chief Scientific Officer and Executive Vice President and
Andres A. Gutierrez, M.D., Ph.D., the Company’s Chief Medical Officer
and Executive Vice President, during a plenary session at the
Immuno-Oncology 360° Conference at the Crowne Plaza Times Square in New
York City. The session begins at 4:00 p.m. ET and the Company’s
presentation begins at 4:55 p.m. ET.

Drs. Petit and Gutierrez will provide an overview of the Company’s
proprietary Lm platform, including the following features that
have been observed:

  • Ability to generate CD8+ T cells rapidly and against large percentage
    of peptides/neoantigens targets;
  • Excellent priming without adding adjuvant, systemic pro-inflammatory
    immune “macroenvironment”;
  • Antigen spreading demonstrated in clinical trials including our
    neoantigen-directed drug constructs;
  • No neutralizing antibodies allowing for repeat boosting;
  • Efficacy signals include single agent complete responses in late stage
    cancer and improved survival; and
  • Manageable safety profile – nearly 500 patients treated to date,
    mostly grade 1 or grade 2 treatment related adverse events.

Drs. Petit and Gutierrez will also present an overview of the Company’s
neoantigen-directed therapy programs, ADXS-NEO (customized, personalized
neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens
and other antigens). The presentation will be available on the Company’s
website, www.advaxis.com.

“We are looking forward to presenting an overview of our proprietary Lm
platform which, over the last several years, has accumulated a large
amount of data supporting immune response, clinical activity and safety
in the treatment of multiple cancers. Leveraging the knowledge gained
from our single-antigen targeting constructs, we have further optimized
our Lm vector in the development of our multiple-antigen
targeting constructs. Our discussion today will provide insight into
immunological activity that we’ve observed in our ADXS-NEO clinical
trial,” said Dr. Petit. He concluded, “These preliminary data suggest
our approach may be among the best-in-class for CD8+ T cell response
which we believe is important for successful clinical outcomes.”

“We have a broad pipeline of drug candidates being evaluated for
multiple cancer types at various stages of development. We anticipate
our first drug construct from our ADXS-HOT program, ADXS-503 for
non-small cell lung cancer, to enter the clinic later this quarter.”
said Dr. Gutierrez. He added, “We believe that our neoantigen-directed
drug candidates will likely be used in combination with checkpoint
inhibitors and have the potential to significantly impact the cancer
treatment paradigm.” He concluded, “The preliminary clinical data from
our ADXS-NEO Phase 1 study demonstrate broad and rapid anti-tumor
immunity. We are looking forward to providing clinical data read-outs
from several studies throughout 2019.”

ADXS-NEO, the Company’s personalized neoantigen program, is in an
ongoing Phase 1 dose-escalation study to treat a variety of cancers.
ADXS-HOT is the Company’s off-the-shelf program and consists of several
different drug constructs that target hotspot or shared neoantigens, and
other antigens. We expect the first drug construct from this program,
ADXS-503, or HOT-Lung, will enter the clinic this quarter.

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,
personalized neoantigen-directed immunotherapy, off-the-shelf,
hotspot/cancer antigens neoantigen-directed immunotherapy 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 subject accrual; our ability to avoid
any clinical holds; 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 to resolve FDA’s partial
clinical hold, the ability to get FDA approval for study amendments, the
timing of data read-outs, the ability of our product candidates to
successfully perform in clinical trials; our ability to initiate,
enroll, and execute pilots and clinical trials; our ability to maintain
collaborations; ; 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.

Contacts

Investors:
LHA Investor Relations
Miriam Weber Miller,
(212) 838-3777
mmiller@lhai.com

Source: Advaxis, Inc.


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