Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for serious neurological conditions, today announced that
36-month results from patients enrolled in a Phase 1/2a clinical
study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501
(OpRegen) in patients with geographic atrophy (GA) secondary to
age-related macular degeneration (AMD), will be presented at
Clinical Trials at the Summit (CTS) 2025. CTS will be held June 20
- 21, 2025, and brings together a diverse group of experts from
around the world to discuss ongoing clinical trials and the latest
data, all with the goal of achieving advances in vitreoretinal
care. The presentation, “OpRegen® Retinal Pigment Epithelium (RPE)
Cell Therapy for Patients with Geographic Atrophy (GA): Month 36
Results from the Phase 1/2a Trial,” will be presented by
Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship
Director, Cincinnati Eye Institute (CEI) and University of
Cincinnati School of Medicine, on behalf of Roche and Genentech, a
member of the Roche Group.
About OpRegen
OpRegen (RG6501) is a suspension of allogeneic retinal pigment
epithelial (RPE) cells currently in development for the treatment
of GA secondary to AMD. Subretinal delivery of OpRegen has the
potential to counteract RPE cell loss in GA by supporting retinal
cell health and improving retinal structure and function. OpRegen
is being developed under an exclusive worldwide collaboration
between Lineage, and 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).
About Clinical Trials at The Summit (CTS) 2025
Clinical Trials at the Summit (CTS) 2025 brings together a
diverse group of experts from around the world to discuss ongoing
clinical trials and the latest data, all with the goal of achieving
advances in vitreoretinal care. This program will explore the
partnerships and strategies required to design and execute
effective clinical trials. CTS was founded by Arshad M. Khanani,
MD, MA, Director of Clinical Research at Sierra Eye Associates, and
is Co-Chaired by Jeffrey S. Heier, MD, Ophthalmic Consultants of
Boston and Peter K. Kaiser, MD, Cole Eye Institute, Cleveland
Clinic. CTS is an invitation-only, in-person meeting where
participants will have the exclusive opportunity to interact with
the top national and international key opinion leaders in retina at
the Fontainebleau Las Vegas. For more information visit: www.
https://www.ctsretina.org/.
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 under
a gene editing partnership. 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.
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 studies of a product candidate may not be predictive
of success in subsequent clinical studies of that candidate; that
Roche and Genentech may not successfully advance OpRegen or be
successful in completing further clinical trials for OpRegen and/or
obtaining regulatory approval for OpRegen in any particular
jurisdiction; 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). 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/20250512395886/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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