- Elpida Therapeutics and Catalent have entered a strategic partnership to support late-phase manufacturing of an AAV9 gene therapy for Spastic Paraplegia Type 50.
- The agreement also grants Catalent exclusive manufacturing rights for Elpida’s additional AAV gene therapy pipeline programs.
Elpida Therapeutics and Catalent have announced a strategic partnership focused on late-phase manufacturing support for Elpida’s lead AAV9 gene therapy program targeting Spastic Paraplegia Type 50 (SPG50), an ultra-rare neurodegenerative disorder.
Under the agreement, Catalent will provide manufacturing support for the SPG50 program and receive exclusive manufacturing rights for Elpida’s additional adeno-associated virus gene therapy pipeline candidates. The companies stated that the collaboration is intended to support continued patient access and advance the program toward regulatory submission.
According to Elpida, SPG50 is caused by AP4M1 mutations and begins during infancy, progressing to cognitive impairment, epilepsy, and paralysis by early adulthood if untreated. Catalent said it will use its UpTempo™ AAV manufacturing platform, including its HEK293 cell line, pre-validated AAV plasmids, and analytical assays, to support production of research and GMP-grade materials for process validation and Biologics License Application activities.
“This collaboration with Catalent represents a critical step in ensuring continued patient access to our SPG50 gene therapy program.”
Terry Pirovolakis, Founder and Chief Executive Officer of Elpida Therapeutics
Catalent stated that it has supported more than 80 gene therapy programs across development, clinical manufacturing, and commercialization. The company added that the partnership expands its CDMO and contract manufacturing support for ultra-rare disease gene therapy programs using AAV-based platforms.
