The Center for Breakthrough Medicines (CBM) and jCyte today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell.
| Multi-Year Deal to Focus on Phase 3 Clinical Trial Supplies and Commercial Manufacturing KING OF PRUSSIA, Pa., Sept. 20, 2022 /PRNewswire/ -- The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the unique requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech company focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. Under the terms of the agreement, 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, Chief Executive Officer of 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.” “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,” said Dr. Shannon Blalock, Chief Executive Officer of jCyte. “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 invasive intravitreal injection, which can be easily administered within an ophthalmologist’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. About The Center for Breakthrough Medicines (CBM) CBM is a purposed built cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development for cell therapy, plasmid DNA, and viral vector manufacturing, as well as cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a fully integrated, end-to-end solution, CBM accelerates time to market without compromising quality. About jCyte, Inc. jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative diseases. The Company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative conditions. For more information, visit www.jcyte.com.
SOURCE Center for Breakthrough Medicines |
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