Pharma Focus Asia

Ocugen and CanSinoBIO Enter Strategic Partnership for Gene Therapy Co-Development and Manufacturing

Tuesday, October 01, 2019

Ocugen, Inc.,, a clinical stage biopharmaceutical company focused on innovative therapies that address rare and underserved eye diseases, has entered into a strategic partnership with CanSino Biologics (“CanSinoBIO”)(6185.HK) on Ocugen’s gene therapy pipeline product candidates for inherited retinal diseases, which are currently in development with Schepens Eye Research Institute of Massachusetts Eye and Ear, an affiliate of Harvard Medical School.

Under this strategic collaboration, CanSinoBIO will provide all CMC development and clinical supplies for the development of OCU400, Ocugen’s first gene therapy product candidate in its modifier gene therapy platform. CanSinoBIO maintains the option to support commercial manufacturing for Ocugen. The agreement also provides commercialization rights to CanSinoBIO in Greater China.

“We believe our modifier gene therapy platform, and OCU400 as its first product candidate, has the potential to treat many inherited retinal diseases with one product,” said Shankar Musunuri, Ph.D., MBA, Chairman, CEO and Co-Founder of Ocugen. “A reliable manufacturing partnership is critical for gene therapy clinical trials and commercialization. Partnership with CanSinoBIO, with their state-of-the-art facilities and world class team, provides us a clear path to advance our development and manufacturing processes to reach the clinic.”

OCU400 has received two different orphan drug designations (ODD) from the U.S. FDA. The first, for the treatment of NR3E3 mutation-associated retinal degeneration and, most recently, for the treatment of CEP290 mutation-associated retinal disease.

“We are delighted to partner with Ocugen as they advance their portfolio of AAV-based gene therapies for rare retinal diseases”, said Dr. Xuefeng Yu, the Chairman and Chief Executive Officer of CanSinoBIO. “Our expertise in viral vector platform technologies, product development and manufacturing capabilities will play critical roles to advance OCU400 to the clinic and ultimately to serve patients in desperate need for retinal disease therapies.”

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