Asterias Biotherapeutics Announces Positive Outcome from Safety Review Committee for AST-VAC2; Recommends Continuation of Cli...
11 Luglio 2018 - 1:00PM
Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology
company dedicated to developing cellular immunotherapies to treat
cancer and cell-based therapeutics to treat neurological conditions
associated with demyelination, today announced that the Safety
Review Committee (SRC) for the first clinical trial of AST-VAC2,
held a scheduled meeting to review the safety and tolerability data
generated in the first patient enrolled in the study and
recommended continuation of the study and moving to parallel
enrollment of the second and third patients in the advanced cancer
cohort (Arm A), as planned per the study’s protocol. This initial
clinical trial, which is being sponsored, managed and funded by
Cancer Research UK under a collaboration between Asterias and
Cancer Research UK, will examine the safety and tolerability of
AST-VAC2 in non-small cell lung cancer (NSCLC) as the study’s
primary endpoints. Secondary and tertiary endpoints of the
study include evaluations of the immunogenicity of AST-VAC2 in
NSCLC.
"Based on its review of all available study data
after five doses in the first patient, the Safety Review
Committee’s recommendation to continue the trial without
modification reaffirms our belief that AST-VAC2 is safe and
well-tolerated," commented Dr Edward Wirth, Chief Medical Officer
of Asterias Biotherapeutics. “The committee concluded that the
trial can proceed as planned per protocol - an important step as we
continue the clinical development of AST-VAC2."
The Safety Review Committee reviewed all of the
accumulated safety data generated to date for the first patient in
Arm A (advanced disease), who by the time of the review had
received five, weekly doses of 10 million AST-VAC2 cells.
As specified in the AST-VAC2 clinical trial
protocol, the Safety Review Committee meets on a dosing-driven
basis to review safety and tolerability data from the ongoing
trial. The committee is comprised of a group of medical and
scientific experts and is responsible for reviewing and evaluating
patient safety data in order to safeguard the wellbeing of trial
participants.
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 invokes enhanced stimulation of
immune responses to the protein. Similar to an earlier,
Asterias-sponsored, hematological cancer program which provided
proof-of-concept data in [AML], the AST-VAC2 dendritic cells
instruct the immune system to generate responses against telomerase
and, through this mechanism, target tumor cells. AST-VAC2’s mode of
action is complementary to and potentially synergistic with other
immune therapies such as checkpoint inhibitors or other immune
pathway inhibitors.
About Non-Small Cell Lung Cancer and the
AST-VAC2 Trial
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%.
As currently designed, the first AST-VAC2
clinical trial will enrol up to 24 subjects into one of two
cohorts, depending on the stage of their non-small cell lung
cancer. The first cohort will evaluate AST-VAC2 in up to 12
subjects with advanced non-small cell lung cancer. Subjects in this
cohort, who carry the major histocompatibility gene, HLA-A2, will
receive six weekly injections of AST-VAC2 and will be followed for
safety, immune responses to telomerase and overall clinical
survival. Assuming safety is demonstrated in the first cohort,
enrolment will advance to a second cohort. In the second cohort,
early stage subjects who have had successful resection of their
tumour with no evidence of metastasis will be enrolled. Up to 12
subjects in this second cohort who carry the major
histocompatibility allele HLA-A2 will receive six, weekly
injections of AST-VAC2 and will be followed for safety, immune
responses to telomerase, overall clinical survival and time to
relapse. Both cohorts will also have a control group consisting of
patients that meet all inclusion/exclusion criteria for the study
but who do not have the HLA-A2 marker. Subjects will be followed
for one year for immune response to telomerase and for 2 years for
the survival endpoints. The supply of AST-VAC2 to be used in this
trial is being manufactured by Cancer Research UK’s Biotherapeutics
Development Unit.
About Asterias
Biotherapeutics
Asterias Biotherapeutics, Inc. is a
biotechnology company dedicated to developing cell-based
therapeutics to treat neurological conditions associated with
demyelination and cellular immunotherapies to treat cancer.
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-VAC2
(antigen-presenting allogeneic dendritic cells) is an allogeneic
cancer immunotherapy. The company's research partner, Cancer
Research UK, has commenced a first-in-human clinical trial of
AST-VAC2 in non-small cell lung cancer. AST-VAC1
(antigen-presenting autologous dendritic cells) is an autologous
cancer immunotherapy with promising efficacy and safety data from a
Phase 2 study in Acute Myeloid Leukemia (AML). Additional
information about Asterias can be found at
www.asteriasbiotherapeutics.com.
About Cancer Research UK’s Clinical
Development Partnerships
Cancer Research UK’s Clinical Development
Partnerships (CDP) is an initiative that aims to develop promising
anti-cancer agents from companies that are not able to take them
through early phase clinical trials themselves. Under the scheme,
Cancer Research UK sponsors and funds early clinical development,
while companies retain all underlying rights to their programmes.
At the end of the study, companies can decide if they wish to
develop the drug further based on the clinical trial results. If
they choose not to, the charity may secure an alternative partner
and ensure the drug has every possible chance of reaching patients,
with a share of future income returned to Cancer Research UK.
About Cancer Research UK’s Centre for
Drug Development
Cancer Research UK has an impressive record of
developing novel treatments for cancer. The Cancer Research UK
Centre for Drug Development, formerly the Drug Development Office,
has been pioneering the development of new cancer treatments for 25
years, taking over 140 potential new anti-cancer agents into
clinical trials in patients. It currently has a portfolio of around
30 new anti-cancer agents in preclinical development, Phase I or
early Phase II clinical trials. Six of these new agents have made
it to market including temozolomide for brain cancer, abiraterone
for prostate cancer and rucaparib for ovarian cancer. Two other
drugs are in late development Phase III trials. This rate of
success is comparable to that of any pharmaceutical company.
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.
For further information about Cancer
Research UK's work or to find out how to support the charity,
please call 0300 123 1022 or visit
www.cancerresearchuk.org. Follow us
on Twitter and
Facebook.
Contacts:
Investor Relations(510)
456-3892InvestorRelations@asteriasbio.com
or
EVC Group LLCMichael Polyviou/Todd Kehrli(732)
933-2754mpolyviou@evcgroup.com/tkehrli@evcgroup.com
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