Asterias Announces Major AST-VAC2 Development Milestone: First cGMP-Compliant Lot Successfully Manufactured to Support First ...
August 14 2017 - 7:00AM
Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology
company pioneering the field of regenerative medicine, today
announced that Cancer Research UK, supported by Asterias technical
personnel, has successfully completed manufacture of the first cGMP
(current Good Manufacturing Practice) clinical grade lot of
AST-VAC2, which meets all specifications for release. This lot will
provide clinical trial material for patients enrolling in the first
clinical study evaluating AST-VAC2 in non-small cell lung cancer.
“The successful production of this first cGMP
lot of AST-VAC2 is a major step towards initiating the upcoming
study in non-small cell lung cancer,” said Mike Mulroy, President
and Chief Executive Officer. “With its potential as a ready-to-use,
off-the-shelf cancer immunotherapy, AST-VAC2 represents an exciting
opportunity for Asterias in the rapidly evolving cancer
immunotherapy sector.”
Investigational therapies intended for human
clinical applications must be manufactured in accordance with cGMP
standards designed to help assure the safety and potency of drug
products. To achieve cGMP standards, a product must be manufactured
and released according to rigorous systems designed to ensure
appropriate control of manufacturing facilities, equipment, raw
materials, processes and testing procedures. Under the company’s
agreement with Cancer Research UK, Asterias has transferred its
innovative laboratory scale AST-VAC2 manufacturing process to
Cancer Research UK’s Biotherapeutics Development Unit, which has
developed and optimized the process for cGMP manufacture and is
responsible for producing cGMP AST-VAC2 for use in the upcoming
clinical study in non-small cell lung cancer.
About AST-VAC2
AST-VAC2 is an innovative immunotherapy product
that contains mature dendritic cells derived from pluripotent stem
cells. These non-patient specific (allogeneic) AST-VAC2 cells are
engineered to express a modified form of telomerase, a protein
widely expressed in tumor cells, but rarely found in normal cells.
The modified form of telomerase permits enhanced stimulation of
immune responses to the protein. The AST-VAC2 dendritic cells
instruct the immune system to generate responses against telomerase
which will target tumor cells. AST-VAC2 is based on a specific mode
of action that is complementary and potentially synergistic to
other immune therapies.
About Non-Small Cell Lung
Cancer
Lung cancer (both small cell and non-small cell)
is the leading cause of cancer-related death, accounting for about
one-quarter of all cancer deaths and more than colorectal, breast,
and prostate cancers combined. Non-small cell lung cancer (NSCLC)
accounts for about 80% to 85% of lung cancers, according to the
American Cancer Society. The three main types of NSCLC are
adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
The American Cancer Society’s estimates for lung cancer in the
United States for 2017 are: about 222,500 new cases of lung cancer,
and about 155,870 deaths from lung cancer. Despite the large number
of people afflicted by non-small cell lung cancer, patients remain
vastly underserved due to a scarcity of effective treatments.
According to statistics published by Cancer Research UK, the five
year survival rate for lung cancer patients in England and Wales is
less than 10%.
About Asterias
Biotherapeutics
Asterias Biotherapeutics, Inc. is a
biotechnology company pioneering the field of regenerative
medicine. The company's proprietary cell therapy programs are based
on its pluripotent stem cell and immunotherapy platform
technologies. Asterias is presently focused on advancing three
clinical-stage programs which have the potential to address areas
of very high unmet medical need in the fields of neurology and
oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently
in a Phase 1/2a dose escalation clinical trial in spinal cord
injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is
undergoing continuing development by Asterias based on promising
efficacy and safety data from a Phase 2 study in Acute Myeloid
Leukemia (AML), with current efforts focused on streamlining and
modernizing the manufacturing process. AST-VAC2 (antigen-presenting
allogeneic dendritic cells) represents a second generation,
allogeneic cancer immunotherapy. The company's research partner,
Cancer Research UK, plans to begin the first clinical trial of
AST-VAC2 in non-small cell lung cancer in 2017. Additional
information about Asterias can be found at
www.asteriasbiotherapeutics.com.
About Cancer Research UK
Cancer Research UK is the world’s leading cancer
charity dedicated to saving lives through research. Cancer
Research UK’s pioneering work into the prevention, diagnosis and
treatment of cancer has helped save millions of lives. Cancer
Research UK receives no government funding for its life-saving
research. Every step it makes towards beating cancer relies on
vital donations from the public. Cancer Research UK supports
research into all aspects of cancer through the work of over 4,000
scientists, doctors and nurses.
FORWARD-LOOKING
STATEMENTSStatements pertaining to future financial and/or
operating and/or clinical research results, future growth in
research, technology, clinical development, and potential
opportunities for Asterias, along with other statements about the
future expectations, beliefs, goals, plans, or prospects expressed
by management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as "will," "believes," "plans,"
"anticipates," "expects," "estimates") should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the businesses of Asterias,
particularly those mentioned in the cautionary statements found in
Asterias' filings with the Securities and Exchange Commission.
Asterias disclaims any intent or obligation to update these
forward-looking statements.
Contacts:
Investor Relations
(510) 456-3892
InvestorRelations@asteriasbio.com
or
EVC Group, Inc.
Michael Polyviou/Greg Gin
(646) 445-4800
mpolyviou@evcgroup.com
Media
Thomas D. Gibson
GIBSON Communications, LLC
(201) 476-0322 – Main
(201) 264-3646 – Mobile
tom@tomgibsoncommunications.com
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