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 Brian M.
Culley, Lineage’s Chief Executive Officer, will be presenting at
the International Society for Stem Cell Research (ISSCR) 2024
Copenhagen International Symposium, PSC-Derived Cell Therapies:
Clinical Advances, NextGen Technologies, and the Path to Success.
Mr. Culley has been invited to participate as part of a panel
entitled “Clinical Trial Updates: PSC-Derived Therapies of the
Eye,” on Wednesday, October 2nd, 2024, from 10:30 am to 12 pm CEST.
The panel is being chaired by Kapil Bharti, Ph.D., Senior
Investigator and Scientific Director, Ocular and Stem Cell
Translational Research Section at the National Eye Institute (NEI),
and will also feature executive presenters from Vision Care and
Regenerative Patch Technologies, Inc. The 2024 Copenhagen
International Symposium will take place October 2 – 4, 2024 at The
Black Diamond, Royal Danish Library, Copenhagen, Denmark, and is
being presented by the ISSCR in partnership with Novo Nordisk.
RG6501 (OpRegen) is a suspension of human allogeneic retinal
pigment epithelial (RPE) cells currently in development for the
treatment of GA secondary to AMD. OpRegen subretinal delivery has
the potential to counteract RPE cell loss in areas of GA lesions by
supporting retinal cell health and improving retinal structure and
function. It is being developed under an exclusive worldwide
collaboration between Lineage, Roche, and Genentech, a member of
the Roche Group, and is currently being evaluated in a Phase 2a
clinical study in patients with GA secondary to AMD
(ClinicalTrials.gov Identifier: NCT05626114).
The 2024 Copenhagen International Symposium presentation,
“OpRegen®️: A Suspension Of Allogeneic Retinal Pigment Epithelial
(RPE) Cells In Patients With Geographic Atrophy (GA) Secondary To
Age-Related Macular Degeneration (AMD),” will be available on the
Events and Presentations section of Lineage’s website, following
the conclusion of the ISSCR panel presentation.
About The 2024 Copenhagen International Symposium:
PSC-Derived Cell Therapies: Clinical Advances, NextGen
Technologies, and the Path to Success
Pluripotent stem cell-derived cell therapies are accelerating
rapidly into clinical trials. The ISSCR, in partnership with Novo
Nordisk, is pleased to invite attendees to Copenhagen, Denmark in
October 2024 for an event that will gather pioneers at the
forefront of ESC and iPSC-derived cell therapies. Here,
world-renowned scientists and innovators will share the latest
updates on ongoing clinical trials, as well as groundbreaking
platforms and technologies that will revolutionize the next
generation of cell therapies for devastating and intractable
diseases. For more information visit
https://www.isscr.org/upcoming-programs/2024-copenhagen-international-symposium/#program
or follow the organization on X/Twitter: @ISSCR.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center,
dose-escalation trial evaluating a single administration of OpRegen
delivered subretinally in patients with bilateral GA secondary to
AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3
cohorts enrolled only legally blind patients with a best corrected
visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled
12 patients with impaired vision (BCVA from 20/65 to 20/250 with
smaller mean areas of GA). Cohort 4 also included patients treated
with a new “thaw-and-inject” formulation of OpRegen, which can be
shipped directly to sites and used immediately upon thawing,
removing the complications and logistics of having to use a dose
preparation facility. The primary objective of the study was to
evaluate the safety and tolerability of OpRegen as assessed by the
incidence and frequency of treatment-emergent adverse events.
Secondary objectives include evaluating the preliminary activity of
OpRegen treatment by assessing the changes in ophthalmological
parameters measured by various methods of primary clinical
relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of
visual function. GA is a leading cause of adult blindness in the
developed world, affecting at least 5 million people globally.
There are two forms of advanced AMD: neovascular AMD and GA. GA and
neovascular AMD can occur simultaneously in the same eye, and
patients treated for neovascular AMD may still go on to develop GA.
GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel, “off-the-shelf,” cell therapies to
address unmet medical needs. Lineage’s programs are based on its
proprietary cell-based technology platform and associated
development and manufacturing capabilities. From this platform,
Lineage designs, develops, manufactures, and tests specialized
human cells with anatomical and physiological functions similar or
identical to cells found naturally in the human body. These cells
are created by applying directed differentiation protocols to
established, well-characterized, and self-renewing pluripotent cell
lines. These protocols generate cells with characteristics
associated with specific and desired developmental lineages. Cells
derived from such lineages are transplanted into patients in an
effort to replace or support cells that are absent or dysfunctional
due to degenerative disease, aging, or traumatic injury, and to
restore or augment the patient’s functional activity. Lineage’s
neuroscience focused pipeline currently includes: (i) OpRegen, a
retinal pigment epithelial cell therapy in Phase 2a development
under a worldwide collaboration with Roche and Genentech, a member
of the Roche Group, for the treatment of geographic atrophy
secondary to age-related macular degeneration; (ii) OPC1, an
oligodendrocyte progenitor cell therapy in Phase 1/2a development
for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1),
an auditory neuronal progenitor cell therapy for the potential
treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural
cell therapy for the potential treatment of vision loss due to
photoreceptor dysfunction or damage; and (v) RND1, a novel
hypoimmune induced pluripotent stem cell line being developed in
collaboration with Eterna Therapeutics Inc. For more information,
please visit www.lineagecell.com or follow the company on X/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.
Lineage’s forward-looking statements are based upon its current
expectations and beliefs and involve assumptions that may never
materialize or may prove to be incorrect. Such statements include,
but are not limited to, statements relating to: the potential
therapeutic benefits of OpRegen in patients with GA secondary to
AMD. 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 following risks: that positive
findings in early clinical and/or nonclinical studies of a product
candidate may not be predictive of success in subsequent clinical
and/or nonclinical studies of that candidate; that OpRegen may
never be proven to provide durable anatomical functional
improvements in dry-AMD patients, that the ongoing Israel-Hamas war
may materially and adversely impact our manufacturing processes,
including cell banking and product manufacturing for our cell
therapy product candidates, all of which are conducted by our
subsidiary in Jerusalem, Israel; and those risks and uncertainties
inherent in Lineage’s business and other risks discussed in
Lineage’s filings with the Securities and Exchange Commission
(SEC). 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. All forward-looking statements are
expressly qualified in their entirety by these cautionary
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240925984921/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Russo Partners – Media Relations Nic Johnson or David
Schull (Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com) (212) 845-4242
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