Express | Genentech to collaborate on nearly $700 million to develop stem cell therapies to treat common blinding eye diseases

▎ WuXi AppTec content team editor

Lineage Cell Therapeutics announced that it has entered into a global exclusive partnership and licensing agreement with Roche's Genentech to develop and commercialize OpRegen, a retinal pigment epithelial cell (RPE) cell replacement therapy for the treatment of ophthalmic diseases, including geographic atrophy atrophy) of late dry age-related macular degeneration (AMD).

AMD is the leading cause of vision loss in people over the age of 60, with dry AMD accounting for 85-90%. OpRegen uses RPE derived from embryonic stem cells, which replaces the lack of RPE cells in patients. These cells can support the renewal and regeneration of photoreceptor cells and maintain the stability of the inner environment of the outer layer of the retina. The project is conducting a phase 1/2a open-label, dose-escalating clinical trial in patients with advanced dry AMD with pattern atrophy to evaluate safety and efficacy. Clinical trials currently available have demonstrated that all 4 amD patients showed improvements in vision after 12 months of treatment, and that the difference in vision between the treated and untreated control groups remained statistically significant at 15 months.

Image source: Lineage official website

Under the terms of the partnership agreement, Lineage will complete activities related to ongoing clinical trials and be responsible for certain production activities. Genentech will be responsible for the further clinical development and commercialization of the OpRegen project. Genentech will make an advance payment of $50 million to Lineage, and Lineage will also be eligible for additional development, approval, and sales milestone payments of up to $620 million, a tiered royalty on net product sales for future products.

Mr. Brian M. Culley, CEO of Lineage, said: "Genentech hopes that combining our cell therapy technology with its ophthalmic expertise and capabilities will help advance the OpRegen project more quickly. We believe this therapy can be successfully applied to patients with severe eye diseases such as dry AMD. We believe OpRegen's current findings represent a paradigm shift that many believe cannot be achieved with cell therapy, by restoring retinal tissue, potentially preventing or reversing the expansion of pattern atrophy. Lineage will also continue to focus on advancing our spinal cord injury and oncology programs. ”