The University of Pennsylvania’s Gene Therapy Program (GTP) has signed a collaboration agreement with contract manufacturer The Center for Breakthrough Medicines (CBM) worth an estimated $75-$100 million.
This partnership is focused on moving therapeutics from concept to clinic by connecting some of Penn’s established gene therapy platforms with CBM’s manufacturing and analytical capacity. The aim is to allow small biotech firms, universities, and large pharmaceutical companies to advance gene therapies from discovery to First-In-Human (FIH) studies with less risk and expense.
Penn’s gene therapy expertise has already been applied to numerous commercially sponsored clinical programs. According to a release from CMB, this can avoid the typical capital-intensive infrastructure builds associated with gene therapy manufacturing. Gene therapy developers should be able to enter the field sooner and with less risk with confidence that this platform is scalable for later clinical stages and commercialization.
Under the renewable five-year deal, CBM will be the only for-profit contract development and manufacturing organization (CDMO) with commercial rights to certain aspects of GTP’s gene therapy manufacturing platform, advanced analytics, and any future process or analytical improvements achieved through their collaboration.
“This agreement represents a giant leap forward for the Center for Breakthrough Medicines and its mission to accelerate the development and manufacturing of life-saving gene therapies,” said Audrey Greenberg, Co-founder, Center for Breakthrough Medicines. “This partnership with the GTP at Penn enables our clients the potential to advance to Investigational New Drugs with a high-quality process, materials and analytical methods.”
More than 1,300 gene or cell therapies are estimated to be in development for oncology alone. The world market for such treatments is expected to reach almost $14 billion by 2026.
“Our mission at the Penn Gene Therapy Program is to discover, translate and greatly accelerate the development of next-generation gene transfer vectors and their application in the treatment of a variety of acquired and inherited diseases,” said James M. Wilson, MD, PhD, Director, Gene Therapy Program; Rose H. Weiss Professor and Director, Orphan Disease Center; and Professor of Medicine and Pediatrics, Perelman School of Medicine at the University of Pennsylvania.
As part of the partnership Penn will receive access to a GMP manufacturing partner with 700,000 planned square footage capacity plus a Sponsored Research Agreement to continue advancing the field of gene therapies. A primary goal of the partnership is to decrease the development costs, timelines, and manufacturing Costs of Goods Sold (COGS), thus increasing the accessibility of life-changing treatments to patients.
“Our collaboration with the GTP at Penn will allow CBM the ability to offer accelerated gene therapy manufacturing services under one roof regardless of where a program is in its development timeline,” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines.
“With this access to GTP’s gene therapy production expertise, CBM becomes an appealing manufacturing partner with a differentiated offering. We will offer the best of an academic vector core (speed to clinic) and commercial CDMO (commercially viable process) combined.”
This deal comes on the heels of Penn GTP’s expansion to the Discovery Lab’s campus, located in the same facility as CBM.
