Asterias Biotherapeutics Announces Positive Outcome from Second Safety Review Committee Meeting and Open Enrollment for VAC2 ...
04 Settembre 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 VAC2 has held its second scheduled meeting to
review the safety and tolerability data generated in patients two
and three enrolled in the study and recommended continuation of the
study and moving to open enrollment in the advanced disease 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, will examine the safety and tolerability of VAC2 in
NSCLC as the study’s primary endpoints. Secondary and tertiary
endpoints of the study include evaluations of the immunogenicity of
VAC2 in NSCLC.
"We are encouraged that VAC2 was found to be
safe and well-tolerated in all three patients and are enthusiastic
for Cancer Research UK to begin open enrollment of the advanced
disease cohort,” commented Dr. Edward Wirth, Chief Medical Officer
of Asterias Biotherapeutics. “Cancer Research UK recently opened a
second site in Birmingham, England to support enrollment and we are
pleased with how the study is progressing.”
The Safety Review Committee has now reviewed
accumulated safety data generated to date for the first three
patients in the advanced disease cohort. Each patient has now
received all six weekly doses of 10 million VAC2 cells per
protocol.
As specified in the 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 VAC2
VAC2 is an innovative immunotherapy product that
contains mature dendritic cells derived from pluripotent stem
cells. These non-patient specific (allogeneic) 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 using an
autologous approach, the VAC2 dendritic cells instruct the immune
system to generate responses against telomerase and, through this
mechanism, target tumor cells. 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
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 VAC2 clinical
trial will enroll 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 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 VAC2 and will be followed for safety, immune
responses to telomerase and overall clinical survival. These
survival results will be compared directly to a control group who
meet all of the other inclusion/exclusion criteria but do not
possess the HLA-A2 gene. 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 VAC2 and will be followed for safety, immune
responses to telomerase, overall clinical survival and time to
relapse. These survival results will again be compared directly to
a control group who meet all of the inclusion/exclusion criteria of
cohort 2 but are not HLA-A2+. Subjects will be followed for one
year for immune response to telomerase and for 2 years for the
survival endpoints. The supply of VAC2 to be used in this trial is
being manufactured by Cancer Research UK’s Biotherapeutics
Development Unit. Asterias and Cancer Research UK are exploring the
combination of VAC2 with an immune pathway inhibitor.
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 two clinical-stage
programs which have the potential to address areas of very high
unmet medical need in the fields of neurology and oncology. OPC1
(oligodendrocyte progenitor cells) is currently in a Phase 1/2a
dose escalation clinical trial in spinal cord injury. 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 VAC2
in non-small cell lung cancer. Asterias is also sponsoring
pre-clinical work in two conditions with a demyelinating component:
Multiple Sclerosis and White Matter Stroke, and is evaluating other
cancer indications where its immunotherapy platform could provide
therapeutic benefit. 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 funding from the UK government
for its life-saving research. Every step it makes towards beating
cancer relies on vital donations from the public.
- Cancer Research UK has been at the heart of the progress that
has already seen survival in the UK double in the last 40
years.
- Today, 2 in 4 people survive their cancer for at least 10
years. Cancer Research UK’s ambition is to accelerate progress so
that by 2034, 3 in 4 people will survive their cancer for at least
10 years.
- Cancer Research UK supports research into all aspects of cancer
through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters, Cancer Research UK's
vision is to bring forward the day when all cancers are cured.
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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