Center for Breakthrough Medicines signs agreement to manufacture jCyte's retinal degenerative disease cell therapy

Center for Breakthrough Medicines signs agreement to manufacture jCyte’s retinal degenerative disease cell therapy

jCell is a regenerative cell therapy for retinitis pigmentosa (RP) and other retinal degenerative diseases, which has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.

Under the terms of the agreement, CBM will provide supplies for Phase 3 clinical trials and a commercial drug upon approval of the Biological License Application (BLA) of jCyte’s proprietary jCell platform technology. CBM will also provide all chemistry, manufacturing and control (CMC) work enabling the BLA to support the program through regulatory approval and commercialization.

RP is a rare genetic disease that is usually diagnosed in children and adolescents. It causes progressive vision loss leading to legal blindness in early adulthood. Nearly 2 million people suffer from the disease worldwide, including approximately 100,000 people in the United States, making RA the leading cause of inherited blindness. To date, there is no approved treatment for 99% of patients with PsA.

jCell is an investigational treatment for RP involving a simple, minimally invasive intravitreal injection, which can be administered in an ophthalmologist’s office. The primary mechanism of action is the sustained release of established neurotrophic factors, which have been shown to reduce photoreceptor cell death and promote surviving photoreceptor function. The therapy aims to preserve vision by intervening in the disease process at a time when host photoreceptor function can be protected and potentially restored.

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