Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies in Ocular and Retinal Diseases

TAMPA, Fla. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--GelMEDIX Inc., a biotechnology company developing regenerative therapies to restore vision, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced a global partnership to access Catalent’s GMP-induced pluripotent stem cells (iPSC) and Catalent’s cell therapy manufacturing expertise and capabilities to support the development and clinical manufacturing of GelMEDIX’s iPSC-derived cell therapies to treat ocular and retinal diseases.

“Catalent is proud to work with GelMEDIX to support this important clinical program of next‑generation therapies for ocular and retinal diseases,” said David McErlane, Biologics Group President at Catalent. “We look forward to supporting these early development efforts and helping bring transformative treatments to patients.”

“We are excited to partner with Catalent, a leader in developing and manufacturing iPSCs and therapies derived from these cells, to bring our vision-restoring therapies into clinical trials,” said Max Cotler, PhD, Chief Executive Officer, GelMEDIX. “Establishing this partnership early positions us to accelerate our progress toward the clinic for our lead programs focused on restoring vision in patients.”

Under the agreement, GelMEDIX will partner with Catalent for iPSC and cell therapy development and will access Catalent’s proprietary, off-the-shelf, GMP-compliant iPSC lines and Catalent’s GMP iPSC and iPSC-derived cell therapy manufacturing capabilities. Catalent, as a global leader in the development and manufacturing of human iPSCs and iPSC-derived cells, will also support the process development, analytical development, process scale-up and GMP manufacturing of GelMEDIX’s iPSC-derived therapies, from early development through all clinical stages.

About GelMEDIX Inc.

GelMEDIX is a biotechnology company developing regenerative therapies that restore vision by regenerating damaged retinal cells and preserving the essential structures required for sight. GelMEDIX programs are based on the company’s proprietary injectable hydrogel scaffold technology platform, which is engineered to optimize the delivery, efficacy and safety of cell and gene therapies. The company is focusing this platform on eye diseases that lack effective treatment options, with an initial focus on late-stage Geographic Atrophy (GA). In addition to developing a pipeline of next-generation regenerative therapies for ophthalmic diseases, GelMEDIX aims to optimize the potential of its regenerative medicine technology platform by forging partnerships to optimize cell and gene therapies for other degenerative disorders. GelMEDIX is based in the Kendall Square district of Cambridge, Massachusetts. For more information, visit www.gelmedix.com.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

For more information, visit www.catalent.com.

GelMEDIX:

Max Cotler, CEO
max@gelmedix.com

Catalent:

Laura Hortas, Vice President, Corporate Communications
Laura.hortas@catalent.com