- Lineage to Receive $2 Million Upfront and up to $67 Million
in Development and Commercial Milestones Plus Royalties
- Partnership Leverages the VAC Allogeneic Cancer
Immunotherapy Vaccine Platform and Immunomic’s Proprietary Tumor
Associated Antigen to Generate a Novel Oncology Product
Candidate
- Immunomic Will be Responsible for Future Clinical
Development and Commercialization Costs
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel cell
transplants for serious medical conditions, today announced a
worldwide license and development collaboration agreement with
Immunomic Therapeutics, Inc., (“ITI”), a privately-held
clinical-stage biotechnology company pioneering the study of
nucleic acid immunotherapy platforms. The collaboration will
generate a novel product candidate derived from Lineage’s VAC
allogeneic cancer immunotherapy platform and targeting a
proprietary Tumor Associated Antigen (TAA) construct provided by
ITI, for the treatment of glioblastoma multiforme (GBM). Lineage
and ITI will collaborate in the manufacturing and clinical
development of a novel VAC product candidate. Following the full
development and delivery of Current Good Manufacturing Practice
(cGMP) VAC product material, ITI will assume full and independent
clinical and commercial responsibility and further advancement of
the program. Under the terms of the agreement, Lineage will be
entitled to upfront payments totaling $2 million anticipated in the
first year and up to $67 million in development and commercial
milestones across multiple indications and territories. Lineage
also will be eligible to receive royalties up to 10% on net sales
of future products.
“The VAC platform provides us with the opportunity to generate a
broad pipeline of product candidates, each targeting a different
type of cancer,” stated Brian Culley, Lineage CEO. “This
collaboration represents the first of many partnerships we hope to
enter into with our platform and we believe it helps further
validate VAC as a promising new therapeutic vaccine platform. Our
objective is to leverage our technology to generate additional
VAC-derived cell therapies for our pipeline, as well as in
collaboration with partners, capitalizing on the strength of
Lineage’s recent manufacturing and cell transplant success. These
alliances also will diversify our oncology pipeline across more
programs, providing new opportunities for success without the
financial burden of independent development. We appreciate ITI
selecting our antigen delivery platform for this collaboration and
look forward to a productive partnership on this new VAC-derived
product candidate. We also are eager to collaborate with additional
partners on future versions of VAC.”
“We’re very pleased to collaborate with Lineage, a
well-recognized cell therapy company, to expand our pipeline with
the development of a novel product candidate to treat GBM,”
commented Dr. William Hearl, CEO of ITI. “Over the last several
years, ITI has invested significant capital and development
resources to identifying multiple novel paths forward in GBM. By
teaming up with Lineage, we are hoping to expand our efforts in
this difficult to treat indication and look forward to the benefit
that the VAC immunotherapy platform can bring to our antigen
constructs.”
About Glioblastoma multiforme (GBM)
Glioblastoma multiforme (GBM) (also called glioblastoma) is a
fast-growing glioma that develops from star-shaped glial cells
(astrocytes and oligodendrocytes) that support the health of the
nerve cells within the brain. GBM is often referred to as a grade
IV astrocytoma. These are the most invasive type of glial tumors,
rapidly growing and commonly spreading into nearby brain tissue.
GBMs can arise in the brain “de novo” or evolve from lower-grade
astrocytomas or oligodendrogliomas. In adults, GBM occurs most
often in the cerebral hemispheres, especially in the frontal and
temporal lobes of the brain. GBM is a devastating brain cancer that
typically results in death in the first 15 months after diagnosis,
with only 25% of glioblastoma patients surviving more than one
year, and only 5% of patients surviving more than five years.
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 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 non-small cell
lung cancer (NSCLC) in the advanced and adjuvant settings
(NCT03371485), conducted by Cancer Research UK.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical
stage biotechnology company pioneering the development of vaccines
through its investigational proprietary technology platform,
UNiversal Intracellular Targeted Expression (UNITE), which is
designed to utilize the body’s natural biochemistry to develop
vaccines that have the potential to generate broad immune
responses. The UNITE platform has a robust history of applications
in various therapeutic areas, including infectious diseases,
oncology, allergy and autoimmune diseases. ITI is primarily focused
on applying the UNITE platform to oncology, where it could
potentially have broad applications, including targeting viral
antigens, cancer antigens, neoantigens and producing
antigen-derived antibodies as biologics. In 2020, an investment of
over $77M by HLB Co., LTD, a global pharmaceutical company, enabled
ITI to accelerate application of its immuno-oncology platform, in
particular to glioblastoma multiforme, and rapidly advance other
key candidates in the pipeline, including the most recent
initiative into infectious diseases with development of its vaccine
candidate for COVID-19. The Company has built a large pipeline from
UNITE with eight oncology programs, multiple animal health programs
and a SARS-CoV-2 program to prevent and treat COVID-19. ITI has
entered into a significant allergy partnership with Astellas Pharma
and has formed several academic collaborations with leading
Immuno-oncology researchers at Duke University and the University
of Florida. ITI maintains its headquarters in Rockville, Maryland.
For more information, please visit www.immunomix.com.
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. 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
compensation to Lineage under its license agreement with ITI, the
potential of the VAC platform and product candidates derived from
the platform, Lineage’s plans to advance the VAC platform and
expand its application, including through partnerships.
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 (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 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/20210420005316/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@soleburytrout.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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