- Expansion of Pipeline Into a Third Neuronal Cell Type Builds
on Existing Capabilities
- Intellectual Property Has Been Filed Covering Composition
and Methods for Generating Auditory Neuronal Progenitors
- Hearing Loss Afflicts More Than 5% of the Population; More
Than 430 Million People
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, today announced that the Company
is expanding its novel cell therapy pipeline to include a new
investigational product candidate, an auditory neuronal cell
transplant for the treatment of hearing loss, with an initial focus
on the treatment of auditory neuropathy spectrum disorders. To
support this new therapeutic effort, Lineage has filed for
intellectual property covering the composition and methods for
generating auditory neuronal progenitors which may be capable of
functioning as sensory neurons and the connecting neuronal ganglion
cells of the ear, and to methods of treatment that employ these
cells for the potential treatment of auditory neuropathy. According
to the World Health Organization, hearing loss currently afflicts
over 5% of the world’s population, or more than 430 million people,
and by 2050 it is estimated that one in every ten people, or more
than 700 million people, will have disabling hearing loss.
“Hearing loss is a major sensory deficit which affects an
enormous number of individuals worldwide, yet current approaches
leave much room for improvement. I am pleased to be advising
Lineage and providing insights and experience in the launch of this
new endeavor and working toward developing cell-based solutions for
this condition,” stated Stefan Heller, Ph.D., Edward C. and Amy H.
Sewall Professor, Stanford University School of Medicine,
Department of Otolaryngology – Head & Neck Surgery and
Institute for Stem Cell Biology and Regenerative Medicine
ISCBRM.
“We are excited to announce this new, internally-developed
initiative for Lineage, and to do it so quickly following the
partnership we announced with Roche and Genentech for our lead
program, OpRegen®, in a deal worth up to $670M USD,” added Brian
Culley, Lineage CEO. “Many patients with sensorineural hearing loss
are poorly addressed, cannot benefit from cochlear implants, and/or
have no FDA-approved treatment options. Similar to OpRegen, which
has demonstrated to be able to replace and restore retinal pigment
epithelium cells in patients with vision loss, and OPC1, which
similarly replaces oligodendrocytes for the treatment of spinal
cord injury, replacing auditory neurons or augmenting an existing
but damaged auditory neuron population may provide a benefit beyond
the reach of alternate approaches such as prostheses. We believe
auditory neuronal transplants represent a unique opportunity to
leverage our knowhow and capabilities in cellular differentiation
into a fourth indication with a large unmet need. In addition to
the speed with which the team created this new program from our
internal technology, we have done so with a modest investment of
capital so far, because we were able to take advantage of our
established manufacturing infrastructure and broad knowhow in the
expansion and differentiation of pluripotent cells. This is another
example of the efficiency and versatility of our technology
platform, which is gaining broader awareness, and which offers us a
favorable competitive position in the emerging fields of
regenerative medicine and anti-aging technologies.”
Auditory neuropathy is a hearing disorder in which the inner ear
successfully detects sound but has a problem with sending signals
from the ear to the brain. Current state of the art medical
knowledge suggests that auditory neuropathies play a substantial
role in hearing impairments and deafness. Hearing depends on a
series of complex steps that change sound waves in the air into
electrical signals. The auditory nerve then carries these signals
to the brain. Outer hair cells help amplify sound vibrations
entering the inner ear from the middle ear. When hearing is working
normally, the inner hair cells convert these vibrations into
electrical signals that travel as nerve impulses to the brain,
where the brain interprets the impulses as sound. Auditory
neuropathy can be caused by a number of factors including: (i)
damage to the auditory neurons that transmit sound information from
the inner hair cells – specialized sensory cells in the inner ear –
to the brain; (ii) damage to the inner hair cells themselves; (iii)
inherited genes with mutations or suffering damage to the auditory
system, either of which may result in faulty connections between
the inner hair cells and the auditory nerve, which leads from the
inner ear to the brain; or (iv) damage to the auditory nerve
itself. Researchers are still seeking effective treatments for
those affected with auditory neuropathy.
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 collaboration and license agreement with Roche and
Genentech and activities expected to occur thereunder, the upfront,
milestone and royalty consideration payable to Lineage and
Lineage’s planned use of proceeds therefrom; the potential benefits
of treatment with OpRegen, the potential success of other existing
partnerships and collaborations, the broad potential for Lineage’s
regenerative medicine platform and Lineage’s ability to expand the
same; Lineage’s plans to advance its spinal cord injury, oncology
and auditory neuron programs and announce new disease settings
where it plans to deploy its technology; the projected timing of
milestones of future studies, including their initiation and
completion, the projected timing of interactions with the FDA to
discuss product designation, manufacturing plans and improvements,
and later-stage clinical development; the potential opportunities
for the establishment or expansion of strategic partnerships and
collaborations and the timing thereof, and 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/20220321005294/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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