Market Overview

Advaxis Licenses ADXS-HER2 to OS Therapies for Evaluation in the Treatment of Osteosarcoma


Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company
focused on the discovery, development and commercialization of
immunotherapy products, and OS Therapies LLC, a clinical-stage
therapeutic company focused on the identification, development and
commercialization of treatments for osteosarcoma, today announced that
Advaxis has granted a license to OS Therapies for the use of ADXS31-164,
also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma
in humans.

Osteosarcoma is an aggressive cancerous tumor that forms in bone.
Although it is rare, osteosarcoma is the most common type of bone
cancer, and is most frequently found in children and young adults.
Current treatment options are limited and there have been no new
treatment options in more than thirty years.

Under the terms of the license agreement, OS Therapies, in collaboration
with the Children's Oncology Group (COG)1, will be
responsible for the conduct and funding of a clinical study evaluating
ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will
receive an upfront payment, reimbursement for product supply and other
support, clinical, regulatory, and sales-based milestone payments, and
royalties on future product sales. Additional details of the financial
terms have not been disclosed.

"Advaxis is pleased to license ADXS-HER2 to OS Therapies for human
clinical trials in osteosarcoma. ADXS-HER2, which is already approved in
the U.S. for the adjuvant treatment of osteosarcoma in canines, has the
potential to provide a new treatment option for human osteosarcoma
patients," said Kenneth A. Berlin, President and Chief Executive Officer
of Advaxis. "As Advaxis is primarily focused on developing
neoantigen-directed therapeutics, this license agreement will allow for
the clinical potential of ADXS-HER2 to be explored in osteosarcoma
without financial support from Advaxis, building on earlier work
performed by us with ADXS-HER2 in a Phase 1 clinical trial."

"The OS Therapies mission is to develop and commercialize new
therapeutics for the treatment of osteosarcoma, a deadly and extremely
underserved pediatric cancer. We are excited about the opportunity to
evaluate ADXS-HER2 in this indication, as its clinical profile has shown
promise to date," said Paul Romness, Chief Executive Officer of OS
Therapies. "Our initial focus is on the most common genetic mutation
found in osteosarcoma, and we believe that HER2, and more specifically
ADXS-HER2, holds potential to impact the treatment paradigm."

1 The Children's Oncology Group (,
a member of the NCI National Clinical Trials Network (NCTN), is the
world's largest organization devoted exclusively to childhood and
adolescent cancer research with over 10,000 experts worldwide working in
over 200 COG member institutions. COG's mission is to improve the cure
rate and outcome for all children with cancer.

About OS Therapies

OS Therapies was founded by concerned parents and friends of children
with osteosarcoma, and is innovatively funded by public, non-profit, and
private funding. OS Therapies CEO Paul Romness, formerly of Johnson &
Johnson, Amgen and Boehringer Ingelheim, has brought together a group of
industry veterans including Cerecor CEO Peter Greenleaf, as well as an
internationally recognized Osteosarcoma Scientific Advisory Board.

To learn more about OS Therapies, visit

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
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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.

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