The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, entered a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. FDA’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte’s proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization.

“jCyte is conducting truly advanced, groundbreaking research into treating patients with RP and other retinal degenerative diseases, and we are honored to partner with them during this critical phase of their clinical trial program as they prepare for BLA submission and commercialization,” said Joerg Ahlgrimm, CEO, Center for Breakthrough Medicines. “We have built world-class technical teams combined with industry-leading product and process development, manufacturing, and testing capabilities, all located within a single manufacturing facility. Our unique and focused approach simplifies and expedites the completion of critical product and process development work and subsequent manufacturing campaigns, thereby shortening the time to market entry for cell therapies such as jCell. We look forward to working closely with the jCyte management team to fulfill our joint mission of safely getting their innovative cell therapy (jCell) to the many patients suffering from RP and other retinal degenerative diseases who have significant unmet medical needs and no available treatment options.”

Shannon Blalock, CEO of jCyte, said, “We have made tremendous progress in advancing our innovative cell therapy program to this key stage of clinical development, and CBM’s broad manufacturing capabilities, dedicated and experienced team, flexibility to fit our needs, and ability to provide fully dedicated manufacturing suites and analytical testing services tailored to our final drug manufacturing process made them an ideal partner to support our program. RP affects approximately one in 3,500 people worldwide. Our goals are to make jCell the first cell therapy approved to address this devastating condition and the first-line agent of choice. Partnering with a patient-focused, fully integrated, mission-centric CDMO like CBM will help ensure we achieve our goals.” 

RP is a rare genetic disease that is typically diagnosed in children and adolescents. It causes progressive vision loss leading to legal blindness by early adulthood. Nearly 2 million people suffer from the disease worldwide, including approximately 100,000 people in the U.S., which makes RP the leading cause of inherited blindness. To date, there is no approved treatment for 99% of RP patients.
jCell is a first-in-class investigational treatment for RP involving a simple, minimally in-vasive intravitreal injection, which can be easily administered within an ophthalmolo-gist’s office. The principal mechanism of action is the sustained release of established neurotrophic factors which have been shown to reduce photoreceptor cell death and promote the function of surviving photoreceptors. jCell therapy aims to preserve vision by intervening in the disease process at a time when host photoreceptors’ function can be protected and potentially restored.