FUJIFILM Cellular Dynamics And Opsis Therapeutics Announce License With BlueRock Therapeutics For iPSC-Derived Cell Therapy Candidate

FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC), and Opsis Therapeutics, LLC, a joint venture of FUJIFILM Cellular Dynamics and co-founder David Gamm, M.D., Ph.D., focusing on developing cell therapies for patients with ocular diseases, today announced an agreement granting BlueRock Therapeutics (Cambridge, Mass.) 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 strategic 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).

A leading cause of permanent vision impairment and blindness worldwide is the degeneration and loss of photoreceptor cells (rods and cones) in the retina due to age, injury, or IRD. As these photoreceptors are not able to regenerate in humans, one solution is to replace them with a cellular therapy. OpCT-001 is composed of allogeneic human iPSC-derived photoreceptor cells, that once transplanted, are intended to aid in recovery of vision by maturing into cones (responsible for central high acuity and color vision), and rods (responsible for vision at low light levels and peripheral vision).

“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 chief executive officer, of 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.”

“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,” said Seth Ettenberg, president and chief executive officer of BlueRock Therapeutics. “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 is committed to supporting the cell therapy market, and 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. To learn more please refer to the press release: https://www.fujifilmcdi.com/news-item/fujifilm-to-invest-200-million-to-expand-cell-therapy-development/

About AMD/IRD
AMD is the leading cause of irreversible blindness and visual impairment in the world, and experts predict that the number of people affected worldwide will reach 288 million by 2040¹. IRDs are the leading cause of vision loss in persons between 15 and 45 years of age².

¹ “Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis.” Wong, Wan Ling, et al. Wong, Wan Ling, et al. The Lancet Global Health, vol. 2, no. 2, 2014, doi:10.1016/s2214-109x(13)70145-1.
² Genes (Basel). 2018 Apr; 9(4): 215. Published online 2018 Apr 14. doi: 10.3390/genes9040215