- Potent Induction of Immune Responses Observed with VAC2
Vaccine
- Peripheral Antigen-specific Immunogenicity Above 3% Observed
at Multiple Timepoints
- VAC2 Appears Well Tolerated with No Unexpected Adverse
Events
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel cell
therapies for unmet medical needs, and Cancer Research UK, the
world’s leading cancer charity dedicated to saving lives through
research, today announced encouraging preliminary results from an
ongoing Phase 1 clinical study of VAC2 in non-small cell lung
cancer (NSCLC). VAC2 demonstrated remarkably potent induction of
immune responses in all patients dosed to date, with high levels of
peripheral antigen-specific immunogenicity observed at multiple
time points and confirmed by multimer staining. On the basis of
these findings, and following completion of the ongoing VAC2
clinical study in NSCLC, Lineage will seek to evaluate VAC2 in
combination with therapies considered biologically complementary to
VAC2, such as chemotherapy and the immune cell protectant
properties offered by anti-PD1 immunotherapy.
Lineage recently conducted an early exercise of its option to
acquire data from Cancer Research UK and assumed responsibility for
further development of the VAC2 product candidate as well as future
development opportunities derived from the VAC platform, while
Cancer Research UK’s Centre for Drug Development concludes the
ongoing clinical study.
“Based on review of all available data, the therapy was safe and
well tolerated in all patients. While the safety profile was
expected, the immunogenicity data are remarkable and highly
provocative,” stated Christian Ottensmeier, MD, PhD, FRCP,
Professor of Experimental Medicine at the University of Southampton
and Chief Investigator on the VAC2 clinical study.
“Antigen-reactive pentamer staining data induced by VAC2 suggest
that the vaccine is highly potent, inducing significantly higher
levels of antigen-specific T cells, compared with that invoked by
alternative vaccine approaches, such as DNA- and RNA-based
vaccines. From my perspective as an immuno-oncologist these data
support rapid phase II testing, focused on clinical benefit.”
Brian Culley, Chief Executive Officer of Lineage, said:
“Interestingly, one patient experienced a radiological response
following chemotherapy subsequent to VAC2 treatment. Although
anecdotal and occurring after the patient had completed the VAC2
trial, responses in this setting are rare and support further
investigation. Dendritic cells are the most potent
antigen-presenting cells in the body and harnessing their power to
accurately deliver information about foreign material is
re-emerging as an attractive therapeutic modality based on their
consistent safety profile and increasing knowledge of how to deploy
them in the clinical setting. As a leader in the field of cell
therapy, Lineage aims to advance the current VAC2 product candidate
and identify ways to expand the VAC platform through
internally-owned and externally-partnered antigens.”
Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug
Development, said: “We are pleased to see, after several years of
development, the clinical progress that VAC2 has made and the
impact it could have for people with lung cancer, which is the
third most common cancer in the UK. We are excited to continue our
support of the next phase of development of VAC2 and assist with
the expansion of those efforts into additional cancers, and other
potential areas with significant unmet medical need.”
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 can be
modified to carry any antigen, including patient-specific tumor
neo-antigens or viral antigens. VAC2 is currently being tested in a
Phase 1 clinical study in adult patients with non-small cell lung
cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485),
conducted by Cancer Research UK.
About T Cell Induction
Lopes A, Vandermeulen G, Préat V. Cancer DNA vaccines: current
preclinical and clinical developments and future perspectives. J
Exp Clin Cancer Res. 2019;38(1):146.; Sebastian M, Schr�der A,
Scheel B, et al. A phase I/IIa study of the mRNA-based cancer
immunotherapy CV9201 in patients with stage IIIB/IV non-small cell
lung cancer. Cancer Immunology, Immunotherapy
2019;68(5):799-812.
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 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 three 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, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a
development for the treatment of acute spinal cord injuries; and
(iii) VAC, an allogeneic dendritic cell therapy platform for
immuno-oncology and infectious disease, currently in clinical
development for the treatment of non-small cell lung cancer and in
preclinical development for additional cancers and as a vaccine
against infectious diseases, including SARS-CoV-2, the virus which
causes COVID-19. 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,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “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 Lineage’s
plans to advance the VAC2 platform. 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 risks
and uncertainties inherent in Lineage’s business and other risks in
Lineage’s filings with the Securities and Exchange Commission (the
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 Annual
Report on Form 10-K filed with the SEC on March 12, 2020 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/20201013005118/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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