Passage Bio Out-Licenses Rare Disease Programs to GEMMA Biotherapeutics

Passage Bio

PHILADELPHIA, PAPassage Bio, Inc. (NASDAQ: PASG) has announced a series of agreements to out-license its three clinical-stage pediatric lysosomal storage disease programs to GEMMA Biotherapeutics, Inc. (GEMMABio). The deal grants GEMMABio exclusive, worldwide rights to develop and commercialize PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy.

Under the agreements, Passage Bio will receive $10 million upfront for clinical product supply and up to an additional $10 million upon achieving certain GEMMABio business milestones. Passage Bio could also earn up to $114 million in development and commercial milestones, along with future royalties. GEMMABio will assume all financial obligations owed to the University of Pennsylvania for these programs. Passage Bio will support the transition through a services agreement.

“We are excited to have out-licensed our pediatric lysosomal storage disease programs to a company deeply committed to advancing these promising therapies for underserved patient communities,” said Will Chou, M.D., president and CEO of Passage Bio. “This transaction is a key initiative in fulfilling our strategy to focus on advancing our lead asset, PBFT02, in multiple adult neurodegenerative diseases while continuing our preclinical research in high potential CNS indications.”

In addition, Passage Bio has entered into a strategic research and collaboration agreement with GEMMABio. GEMMABio will handle specific preclinical activities for Passage Bio’s research program, including work on Huntington’s disease. The agreement also gives Passage Bio options to start new research programs in four novel central nervous system (CNS) indications.

James M. Wilson, M.D., Ph.D., co-founder of GEMMABio, expressed enthusiasm for the partnership. “By establishing GEMMA Biotherapeutics, we are able to further development of promising genetic medicines for rare patient populations, and we are thrilled to advance the three therapies from Passage Bio, each of which targets a devastating pediatric disease.”

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The agreements also involve amending Passage Bio’s strategic collaboration with the University of Pennsylvania’s Gene Therapy Program. This amendment ends preclinical research programs and terminates future CNS research options and funding of the discovery research program, effective July 31, 2024.

The transaction is expected to extend Passage Bio’s operating cash runway to the end of Q2 2026.

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