Clinical Trials
5
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1990
Active, not recruiting
2
40.0%
Completed
2
40.0%
Recruiting
1
20.0%
No approval data available
- Lineage Cell Therapeutics has launched COR1, a preclinical corneal endothelial cell therapy program targeting Fuchs endothelial corneal dystrophy and bullous keratopathy using its proprietary AlloSCOPE platform. - The program addresses a critical unmet need, as global demand for corneal transplants reaches 12.7 million cases annually while only one donor cornea is available for every 70 diseased eyes. - COR1 leverages manufacturing expertise from Lineage's OpRegen program and aims to provide a consistent, off-the-shelf allogeneic source of corneal endothelial cells without relying on human organ donors. - Fuchs endothelial corneal dystrophy affects approximately 7.33% of adults over 30 years globally, with the patient population projected to rise from 300 million in 2020 to 415 million by 2050.
- Lineage Cell Therapeutics reported positive 36-month Phase 1/2a clinical data for OpRegen cell therapy, showing sustained visual acuity gains and retinal structural support in geographic atrophy patients. - The company achieved its first milestone payment under the $620 million collaboration with Roche and Genentech, based on manufacturing and clinical advancements for the OpRegen program. - Lineage successfully demonstrated large-scale production capabilities through its AlloSCOPE platform, completing cGMP production runs that could enable millions of doses from a single cell line. - The company expanded its pipeline with new collaborations including a $12 million partnership with William Demant Invest for hearing loss therapy and launched diabetes research initiatives.
- The dry age-related macular degeneration market is expected to experience substantial growth through 2034, driven by the uptake of recently approved therapies and the anticipated launch of emerging treatments. - Multiple innovative therapies are advancing through clinical trials, including Gildeuretinol from Alkeus Pharmaceuticals, which demonstrated a 0.25 sq mm per year reduction in geographic atrophy lesion growth compared to placebo in its Phase II/III SAGA trial. - The United States represents the largest market opportunity with approximately 21 million prevalent cases in 2024, while dry AMD accounts for nearly 90% of all AMD cases, representing a vast untapped therapeutic opportunity.
- Long-term 36-month data from the Phase 1/2a trial of RG6501 (OpRegen) for geographic atrophy secondary to AMD will be presented at Clinical Trials at the Summit in June 2025. - OpRegen, an allogeneic retinal pigment epithelial cell therapy developed by Lineage Cell Therapeutics in collaboration with Roche and Genentech, aims to counteract RPE cell loss in geographic atrophy. - The therapy is currently advancing in a separate Phase 2a clinical study, potentially offering a novel treatment approach for geographic atrophy, a leading cause of adult blindness affecting over 5 million people globally.
- Lineage Cell Therapeutics has initiated the DOSED clinical study to evaluate OPC1, a stem cell-derived therapy, using a new delivery system for both subacute and chronic spinal cord injury patients. - The study marks a significant milestone as the first trial to include chronic spinal cord injury patients, expanding the potential treatment population for OPC1 therapy. - OPC1 has demonstrated a strong long-term safety profile in previous trials, with patients being monitored for up to 13 years with no unexpected serious adverse events reported.
- Several therapies are under evaluation in clinical trials for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), addressing the unmet need for effective treatments. - Complement pathway inhibitors like ANX007, danicopan, and AVD-104 are being investigated to modulate the inflammatory response and cell lysis associated with GA progression. - Gene therapies such as JNJ-1887 and cell-based therapies like ASP7317 and RG6501 are showing promise in protecting retinal cells and improving visual function in GA patients. - Antioxidants like elamipretide, glideuretinal, and AREDS2 supplements are also being explored for their potential to reduce GA lesion progression and improve visual outcomes.
- Phase 1/2a trial results for RG6501 (OpRegen) demonstrate significant improvements in outer retinal structure within three months of a single administration in patients with geographic atrophy secondary to AMD. - All five patients in cohort 4 with extensive coverage of GA lesions showed structural improvements and achieved an average 12.8 letter BCVA gain by one year compared to baseline. - The cell therapy, developed through a collaboration between Lineage Cell Therapeutics, Roche, and Genentech, works by delivering allogeneic retinal pigmented epithelial cells to support remaining retinal cells in atrophic areas.
