THOUSAND OAKS, Calif. and
PRINCETON, N.J., Aug. 2, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and Advaxis, Inc. (NASDAQ:ADXS) today announced a global agreement
for the development and commercialization of Advaxis' ADXS-NEO, a
novel, preclinical investigational cancer immunotherapy treatment
that is 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. This collaboration
brings together Amgen's development expertise in immuno-oncology
with Advaxis' MINE™ (My Immunotherapy Neo-Epitopes) program, which
is uniquely positioned to develop a customized approach to cancer
treatment.
Under the terms of the agreement, Amgen receives exclusive
worldwide rights to develop and commercialize ADXS-NEO. Amgen will
make an upfront payment to Advaxis of $40
million and purchase $25
million of Advaxis common stock. Amgen will be fully
responsible for funding clinical and commercial activities. Advaxis
will lead the clinical development of ADXS-NEO through
proof-of-concept, retain manufacturing responsibilities, and
receive development, regulatory and sales milestone payments of up
to $475 million and potential high
single digit to mid-double digit royalty payments based on
worldwide sales.
"Amgen's collaboration with Advaxis leverages and enhances our
development and commercialization expertise in novel
immuno-oncology treatments," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "We look forward to partnering with Advaxis
to advance this highly targeted and patient-specific treatment
option for patients."
"Amgen is a pioneer in the science of using living cells to
develop biologic medicines, making them an incredibly strong
partner to develop and commercialize Advaxis' MINE," said
Daniel J. O'Connor, president and
chief executive officer at Advaxis. "With Amgen's resources,
worldwide reach and a culture that embraces science and innovation,
we are positioned to accelerate the clinical development program
for ADXS-NEO to improve the lives of those who suffer from
cancer."
The Advaxis Lm Technology™ utilizes live attenuated
Listeria monocytogenes (Lm) bioengineered to produce
and deliver tumor antigen/adjuvant fusion proteins within antigen
presenting cells with the goal of generating strong,
T-cell-mediated immunity. For ADXS-NEO, DNA from each patient's
primary tumor and/or metastases as well as normal cells, is
sequenced and compared to identify mutations in genes coding for
potential neo-antigens in the cancer. Advaxis then engineers and
manufactures patient-specific Lm-LLO (listeriolysin O)
vectors capable of immunizing them against neoepitopes exclusive to
their cancer. After the ADXS-NEO infusion, neoepitope peptides
corresponding to each patient's cancer-associated mutations are
delivered directly into their antigen presenting cells by
Lm-LLO, where they can stimulate cellular immune responses
against multiple neoepitopes simultaneously. Clinical trials for
ADXS-NEO are expected to begin in 2017.
About MINE™ (My Immunotherapy Neo-Epitopes) /
ADXS-NEO
MINE™ (My Immunotherapy Neo-Epitopes) and ADXS-NEO are designed to
activate a patient's immune system to respond against the unique
mutations, or neoepitopes, contained in each individual patient's
tumor. This strategy, using massive parallel sequencing, eliminates
the need for predictive algorithms and enables the development of
truly personalized immunotherapies that can be manufactured in a
manner that is cost-effective and timely for patients.
MINE™ will evaluate the immunologic and anti-tumor activity of
this patient tumor-specific, neoepitope-based immunotherapy.
Advaxis and Amgen will use learnings from MINE to identify and
target neoepitopes using Lm Technology™ and later develop
patient specific immunotherapy constructs that incorporate the
neoepitope sequences identified in the patient's tumor cells.
Clinical studies using ADXS-NEO are in development.
Conference Call and Webcast
Advaxis will host a conference call today, Aug. 2, 2016, beginning at 9:30 a.m. ET. Please see below for details.
Conference call numbers:
Domestic/Canada: 888-466-4442
International: 719-325-2480
Conference ID: 2246109
Webcast: http://public.viavid.com/index.php?id=120644
Accessible via the Investor Relations section of Advaxis'
website: http://ir.advaxis.com/
A replay of the conference call and webcast will be available
beginning approximately one hour after the completion of the call.
Access numbers for this replay are 1 (877) 870-5176
(U.S./Canada) and 1 (858) 384-5517
(international); conference ID: 2246109.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
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 Listeria monocytogenes (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 (AXAL),
targets human papillomavirus (HPV)-associated cancers and is in
clinical trials for three potential indications: Phase 2 in
invasive cervical cancer, Phase 1/2 in head and neck cancer, and
Phase 1/2 in anal cancer. The U.S. Food and Drug Administration
(FDA) has granted AXAL orphan drug designation for each of these
three clinical settings, as well as a Special Protocol Assessment
for the Phase 3 AIM2CERV trial in patients with high risk, locally
advanced cervical cancer. AXAL has also been classified as an
advanced therapy medicinal product for the treatment of cervical
cancer by the European Medicines Agency's Committee for Advanced
Therapies. Advaxis has two additional immunotherapy products in
human clinical development: ADXS-PSA in prostate cancer and
ADXS-HER2 in HER2-expressing solid tumors. Advaxis has received
Fast Track Designation for ADXS-HER2 for the treatment of patients
with newly-diagnosed, non-metastatic, surgically-resectable
osteosarcoma and for AXAL for the treatment of high-risk locally
advanced cervical cancer.
For additional information on Advaxis, visit www.advaxis.com and
connect on Twitter, LinkedIn, Facebook, YouTube and Google+.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including estimates of revenues, operating margins, capital
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results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including its most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and Form
8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for
Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
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Amgen or others could identify safety, side effects or
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market.
Amgen's results may be affected by its ability to successfully
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governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
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testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory
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to prevail in present and future intellectual property litigation.
Amgen performs a substantial amount of its commercial manufacturing
activities at a few key manufacturing facilities and also depends
on third parties for a portion of its manufacturing activities, and
limits on supply may constrain sales of certain of its current
products and product candidate development. In addition, Amgen
competes with other companies with respect to many of its marketed
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The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates.
Advaxis Forward-Looking Statement
This media statement 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
immunotherapies. 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, 2015, which is available at
http://www.sec.gov. Advaxis undertakes no obligation to publicly
release the result of any revision to these forward-looking
statements, which may be made to reflect the events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events, except as required by law. You are cautioned
not to place undue reliance on any forward-looking statements.
CONTACTS:
Amgen, Thousand Oaks
Kristen Neese, 805-313-8267
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
Advaxis, Inc.
Greg Mayes, Executive Vice President
and COO
mayes@advaxis.com
609-250-7515
JPA Health Communications (media)
David Connolly
dconnolly@jpa.com
617-543-3915
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SOURCE Amgen