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Lineage Cell Therapeutics announced the presentation of Phase 1/2a clinical study results for RG6501 (OpRegen) at the 2023 Retinal Cell and Gene Therapy Innovation Summit scheduled for April 21, 2023, in New Orleans, LA. OpRegen is being developed to treat geographic atrophy due to age-related macular degeneration (AMD) under a collaboration with Roche and Genentech. This therapy targets a compelling market need, as geographic atrophy affects over 5 million people globally, representing a significant opportunity for Lineage. The clinical presentation will be delivered by Eyal Banin, M.D., Ph.D., focusing on the implications of OpRegen in retinal therapy.
Positive
Presentation of encouraging Phase 1/2a results for RG6501 (OpRegen) at a prominent industry summit.
OpRegen targets geographic atrophy, a major cause of adult blindness affecting over 5 million globally, presenting a strong market opportunity.
Developed under a collaboration with Roche and Genentech, adding credibility and resources.
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None.
CARLSBAD, Calif.--(BUSINESS WIRE)--
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 results from a Phase 1/2a clinical study of RG6501 (OpRegen), will be presented at the 2023 Retinal Cell and Gene Therapy Innovation Summit, organized by the Foundation Fighting Blindness and the Oregon Health & Science UniversityCasey Eye Institute. The meeting will be held April 21st, 2023, at the Marriott New Orleans Warehouse Arts District in New Orleans, LA. The presentation, “Phase 1/2a Study of OpRegen in Patients with Geographic Atrophy (GA),” will be presented by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology at Hadassah-Hebrew University Medical Center. RG6501 (OpRegen) is a retinal pigment epithelium cell transplant therapy currently in development for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). It 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 geographic atrophy secondary to age-related macular degeneration (ClinicalTrials.gov Identifier: NCT05626114).
The 2023 Retinal Cell and Gene Therapy Innovation Summit, "Defining the Preclinical to Clinical Roadmap" will feature presentations that emphasize clinical trial design for gene and cell-based therapies. Representatives from the biotech and pharma industries will come together with physicians and scientists to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal disease therapy options forward.
About the Foundation Fighting Blindness
The Foundation Fighting Blindness was established in 1971 by a passionate group of families driven to find treatments and cures for inherited retinal diseases that were affecting their loved ones. Today, the Foundation Fighting Blindness is the world’s leading private funder of retinal disease research. That funding has been a driving force behind the progress toward cures, including the identification of more than 270 genes linked to retinal disease, and the launch of over 40 clinical trials for potential treatments. For more information, please visit https://www.fightingblindness.org/ or follow the association on Twitter @FightBlindness.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (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 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 and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is 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; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
What is the purpose of the Phase 1/2a study for LCTX's RG6501 (OpRegen)?
The study aims to evaluate the efficacy and safety of RG6501 (OpRegen) in treating geographic atrophy due to age-related macular degeneration.
When will the Phase 1/2a study results for LCTX's OpRegen be presented?
The results will be presented on April 21, 2023, at the 2023 Retinal Cell and Gene Therapy Innovation Summit in New Orleans, LA.
What is geographic atrophy, and why is it important for LCTX?
Geographic atrophy is a severe form of age-related macular degeneration leading to blindness, affecting over 5 million people worldwide, marking it as a significant target for LCTX's OpRegen therapy.
What collaboration does LCTX have related to OpRegen?
Lineage Cell Therapeutics is developing OpRegen in collaboration with Roche and Genentech, enhancing the project's resources and expertise.
What are the next steps for LCTX following the presentation of OpRegen results?
Following the presentation, LCTX will likely continue to advance the clinical development of OpRegen and seek regulatory approvals based on study outcomes.
