Ocugen Engages Kemwell Biopharma for cGMP Manufacture of OCU200

Ocugen, a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases, has entered into an agreement with Kemwell Biopharma to manufacture OCU200, Ocugen’s novel biologic product candidate in preclinical development for treating severely sight-threatening diseases like Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Wet Age-Related Macular Degeneration (Wet-AMD).
 
Kemwell will manage all CMC and clinical manufacturing activities as well as provide OCU200 supplies for IND-enabling toxicology studies and Phase 1/2a clinical trials. Kemwell offers proven expertise in supporting companies with process development, clinical and commercial manufacturing of biologicals at their state-of-the-art facilities located in Bangalore, India.
 
“Biological manufacturing is critical and rate-limiting for Phase 1/2 clinical trials, and this partnership paves the way for us to potentially enter the clinic by 1H2022 as planned,” Shankar Musunuri, chairman, chief executive officer and co-founder, Ocugen. “We are picking a CMO with commercial capabilities with a goal of ensuring product consistency throughout development and minimizing regulatory issues as we drive the development of OCU200.”
 
Anurag Bagaria, chairman and chief executive officer, Kemwell, said, “We are delighted to partner with Ocugen as they advance their portfolio of transformative therapies to cure blindness diseases. We believe our expertise in process development and manufacturing solutions will play a critical role to advance OCU200 into the clinic and could deliver hope to patients with severely sight-threatening diseases who do not respond to currently available therapies.”
 
Ocugen is planning to initiate IND-enabling studies, including GLP toxicology studies next year. DME is the first targeted indication for OCU200, and the Company plans to advance into Phase 1/2a trials in 1H2022. Based on early clinical success in DME, the Company will undertake evaluation of broader indications such as DR and Wet-AMD. In the US alone, over 9.5 million patients struggle with these retinal diseases. Approximately 50% of patients do not respond to current therapies including anti-VEGF treatments. This patient population represents a significant underserved population who are looking for new therapies. OCU200 has a distinct method of action compared to current anti-VEGF therapies and has potential to be a disease-modifying drug based on in vivo and in vitro preclinical studies to date.