Fujifilm Cellular Dynamics, a global developer and manufacturer of human induced pluripotent stem cells (iPSC), and Opsis Therapeutics, a joint venture of Fujifilm Cellular Dynamics and co-founder David Gamm (MD, PhD) focusing on developing cell therapies for patients with ocular diseases, formed an agreement granting BlueRock Therapeutics an exclusive, worldwide license to develop and commercialize an iPSC-derived cell therapy candidate for the treatment of human retinal diseases. BlueRock Therapeutics, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, exercised its option to exclusively license OpCT-001, an iPSC-derived photoreceptor cell therapy for human retinal diseases.

Following the option exercise by BlueRock Therapeutics, Fujifilm Cellular Dynamics and Opsis Therapeutics received an undisclosed license fee and are eligible to receive payments upon achievement of certain development and commercial milestones.

OpCT-001 is the first iPSC therapy candidate to be licensed from the strategic research and development alliance that Fujifilm Cellular Dynamics, Opsis Therapeutics, and BlueRock Therapeutics entered in 2021 to discover and develop off-the-shelf iPSC-derived cell therapies for ocular diseases. The alliance grants BlueRock Therapeutics the exclusive option to license three retinal cell therapy programs focused on dry age-related macular degeneration (AMD) and inherited retinal diseases (IRD).

“We have collaborated closely with BlueRock Therapeutics to develop a new generation of iPSC-derived cell therapies and we are pleased to grant this license as the next step towards moving the OpCT-001 product into the clinic for the treatment of primary photoreceptor diseases,” said Tomoyuki Hasegawa, president and CEO, Fujifilm Cellular Dynamics. “We continue to have a productive partnership with BlueRock Therapeutics and look forward to unlocking the full potential of iPSC technology to create best-in-class cell replacement therapies targeting ocular diseases.”

Seth Ettenberg, president and CEO, BlueRock Therapeutics, said, “The development of iPSC-derived therapies is an exciting scientific frontier that has great potential for restoring vision in patients living with vision impairment and blindness. This agreement is an exciting step in the maturation of our collaboration with the Fujifilm Cellular Dynamics and Opsis Therapeutics team, and we are thrilled to be advancing OpCT-001 to the clinic, with an IND filing planned for later this year.”

Fujifilm Cellular Dynamics recently announced an investment that doubles its existing manufacturing capacity for the development and commercialization of iPSC-derived cell therapies. The new site is expected to be fully operational in 2026.