Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 18

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1
Chunk 18
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 of GA at baseline than earlier cohorts who were legally blind), have recently been analyzed. Despite dry AMD being an irreversible and degenerative disease leading to progressive vision loss, visual acuity gains and retinal structure improvements observed in OpRegen-treated eyes in the Phase 1/2 clinical study continue to persist, suggesting that OpRegen RPE cells may provide durable support to patients’ remaining retinal cells, including those near or within atrophic areas. Evidence of durable engraftment of OpRegen RPE cells has surpassed 5 years in the earliest-treated patients, supporting the potential for OpRegen to be a one-time treatment for patients with dry AMD. Overall, in the Phase 1/2a study (N=24), OpRegen continues to show an acceptable safety profile, which remains unchanged following inclusion of the recently-collected long-term follow-up safety data. 

RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between us and Roche and Genentech. See “Collaborations—Roche Collaboration Agreement,” below.

In November 2022, Genentech launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), the GAlette study with patient enrollment initiated in March 2023. The study is intended to optimize subretinal surgical delivery and evaluate biological activity of OpRegen in up to 60 patients with GA secondary to AMD. The primary objectives of the study are to evaluate (i) the success of subretinal surgical delivery of OpRegen as measured by the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. The secondary objective is to evaluate the biological activity of OpRegen measured by the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. 

OPC1

OPC1 is an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute SCI. OPC1 has an extensive long-term safety profile and has been tested in two clinical trials to date: a five-patient Phase 1 safety trial in acute thoracic SCI, where all active subjects have been followed for at least