Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, announced today that Cancer
Research UK recently completed patient enrollment in the ongoing
Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine
product candidate, for the treatment of non-small cell lung cancer
(“NSCLC”). Under the terms of an existing agreement, Cancer
Research UK will complete the ongoing clinical trial and Lineage
has now assumed responsibility for further clinical development of
the VAC2 product candidate and any future development opportunities
derived from the VAC platform.
“We are pleased that Cancer Research UK has successfully
completed patient enrollment in the VAC2 Phase 1 clinical study and
overcame substantial challenges stemming from the COVID pandemic.
We look forward to initial clinical results from this study being
available later this year,” stated Brian M. Culley, Lineage CEO.
“Clinical data previously collected by Cancer Research UK
demonstrated peripheral immunogenicity in patients with NSCLC
treated with VAC2, providing support to the underlying mechanism of
using allogeneic dendritic cells to present tumor-associated
antigens to the body’s immune system. Simultaneous with Cancer
Research UK efforts to complete enrollment in the current study,
the focus at Lineage has been on making improvements and
modernizations to the VAC manufacturing process, an approach which
we similarly employed in the development of OpRegen. We believe our
focus on manufacturing will help prepare VAC2 for additional
clinical trials and provide a competitive advantage for any future
VAC programs which we advance, either alone or through alliances.
With Cancer Research UK having completed enrollment of the current
study, the team at Lineage also has begun work towards the
submission of an Investigational New Drug Application for clinical
testing of VAC2 in the U.S., which we anticipate submitting to the
FDA later this year.”
Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for
Drug Development, added: “We are delighted to see that this
innovative VAC2 program has reached such an important milestone in
its development and are extremely proud to have played an important
role in establishing its tolerability in lung cancer patients. We
look forward to seeing Lineage advance VAC2 under their leadership
in the future.”
About VAC2
VAC2 is an allogeneic, or non-patient specific “off-the-shelf,”
cancer vaccine product candidate designed to stimulate patient
immune responses to an antigen commonly expressed in cancerous
cells but not in normal adult cells. VAC2, which is produced from a
pluripotent cell technology using a directed differentiation
method, is comprised of a population of nonproliferating mature
dendritic cells. As the most potent type of antigen presenting cell
in the body, dendritic cells instruct the body’s immune system to
attack and eliminate harmful pathogens and unwanted cells. Because
the tumor antigen is loaded exogenously into the dendritic cells
prior to administration, VAC2 is a platform technology that could
be modified to carry selected antigens, including patient-specific
tumor neo-antigens or viral antigens. VAC2 is currently being
tested in a Phase 1 study in adult patients with NSCLC in the
advanced and adjuvant settings (NCT03371485), conducted by 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 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 21 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.
About Cancer Research UK’s Commercial Partnerships
Team
Cancer Research UK is the world’s leading cancer charity
dedicated to saving lives through research. Cancer Research UK’s
specialist Commercial Partnerships Team works closely with leading
international cancer scientists and their institutes to protect
intellectual property arising from their research and to establish
links with commercial partners. Cancer Research UK’s commercial
activity operates through Cancer Research Technology Ltd., a wholly
owned subsidiary of Cancer Research UK. It is the legal entity
which pursues drug discovery research in themed alliance
partnerships and delivers varied commercial partnering
arrangements.
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.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel cell therapies for unmet medical needs.
Lineage’s programs are based on its robust proprietary cell-based
therapy platform and associated in-house development and
manufacturing capabilities. With this platform Lineage develops and
manufactures specialized, terminally differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed to either replace or support
cells that are dysfunctional or absent due to degenerative disease
or traumatic injury or administered as a means of helping the body
mount an effective immune response to cancer. Lineage’s clinical
programs are in markets with billion dollar opportunities and
include four allogeneic (“off-the-shelf”) product candidates: (i)
OpRegen, a retinal pigment epithelium transplant therapy in Phase
1/2a development for the treatment of dry age-related macular
degeneration, which is now being developed under a worldwide
collaboration with Roche and Genentech, a member of the Roche
Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in
Phase 1/2a development for the treatment of acute spinal cord
injuries; (iii) VAC2, a dendritic cell therapy produced from
Lineage’s VAC technology platform for immuno-oncology and
infectious disease, currently in Phase 1 clinical development for
the treatment of non-small cell lung cancer and (iv) ANP1, an
auditory neuronal progenitor cell therapy for the potential
treatment of auditory neuropathy. For more information, please
visit www.lineagecell.com or follow the Company on Twitter
@LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “aim,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “design,” “intend,”
“expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,”
“should,” “would,” “contemplate,” “project,” “target,” “tend to,”
or the negative version of these words and similar expressions.
Such statements include, but are not limited to, statements
relating to the efficacy of using allogeneic dendritic cells to
present tumor-associated antigens to the body’s immune system the
collaboration and license agreement with Roche and Genentech and
activities expected to occur thereunder, the broad potential for
Lineage’s regenerative medicine platform as well as the VAC
technology platform, and Lineage’s ability to expand the same; the
projected timing of milestones of future studies, including their
initiation and completion, projected manufacturing plans and
improvements; the potential for Lineage’s investigational
allogeneic cell therapies to generate clinical outcomes beyond the
reach of traditional methods and provide safe and effective
treatment for multiple, diverse serious or life threatening
conditions. Forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause Lineage’s
actual results, performance or achievements to be materially
different from future results, performance or achievements
expressed or implied by the forward-looking statements in this
press release, including, but not limited to, the risk that
competing alternative therapies may adversely impact the commercial
potential of OpRegen, which could materially adversely affect the
milestone and royalty payments payable to Lineage under the
collaboration and license agreement, the risk that Roche and
Genentech may not be successful in completing further clinical
trials for OpRegen and/or obtaining regulatory approval for OpRegen
in any particular jurisdiction, the risk that Lineage might not
succeed in developing products and technologies that are useful in
medicine and demonstrate the requisite safety and efficacy to
achieve regulatory approval in accordance with its projected
timing, or at all; the risk that Lineage may not be able to
manufacture sufficient clinical and, if approved, commercial
quantities of its product candidates in accordance with current
good manufacturing practice; the risks related to Lineage’s
dependence on other third parties, and Lineage’s ability to
establish and maintain its collaborations with these third parties;
the risk that government-imposed bans or restrictions and
religious, moral, and ethical concerns about the use of hES cells
could prevent Lineage or its partners from developing and
successfully marketing its stem cell product candidates; the risk
that Lineage’s intellectual property may be insufficient to protect
its products; the risk that the COVID-19 pandemic or geopolitical
events may directly or indirectly cause significant delays in and
substantially increase the cost of development of Lineage’s product
candidates, as well as heighten other risks and uncertainties
related to Lineage’s business and operations; risks and
uncertainties inherent in Lineage’s business and other risks
discussed in Lineage’s filings with the Securities and Exchange
Commission (SEC). Lineage’s forward-looking statements are based
upon its current expectations and involve assumptions that may
never materialize or may prove to be incorrect. All forward-looking
statements are expressly qualified in their entirety by these
cautionary statements. Further information regarding these and
other risks is included under the heading “Risk Factors” in
Lineage’s periodic reports with the SEC, including Lineage’s most
recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q
filed with the SEC and its other reports, which are available from
the SEC’s website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Lineage undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220413005356/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Mike Biega (Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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