Elpida Therapeutics, Catalent Partner for Late-Phase AAV Manufacturing

Elpida Therapeutics, a non-profit biotechnology company developing gene therapies for ultra-rare diseases, and Catalent, Inc., a global contract development and manufacturing organization (CDMO), have entered a strategic partnership to support late-phase manufacturing of Elpida’s lead program, an AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50). Under the agreement, Catalent will also be granted exclusive manufacturing rights to Elpida’s other pipeline adeno-associated virus (AAV) gene therapy programs.

SPG50 is an ultra‑rare neurodegenerative disorder caused by AP4M1 mutations, beginning in infancy. Untreated, the disorder leads to cognitive impairment, epilepsy and progressive paralysis by early adulthood.

“This collaboration with Catalent represents a critical step in ensuring continued patient access to our SPG50 gene therapy program. Without this support, the final patient planned for treatment by the end of this year could have marked the end of this therapy’s availability,” said Terry Pirovolakis, Founder and CEO, Elpida Therapeutics. “Together, we are building a path to reach all patients living with SPG50 and, ultimately, other devastating ultra-rare diseases.”

“This partnership reflects Catalent’s commitment to applying our broad gene therapy manufacturing expertise and Patient First approach to programs with significant unmet need,” said David McErlane, Biologics Group President for Catalent. “By leveraging our broad expertise in end‑to‑end AAV capabilities, we look forward to supporting Elpida’s SPG50 program through late‑phase manufacturing so it can advance toward regulatory submission.”

Catalent will utilize its UpTempo AAV manufacturing platform, incorporating its proprietary HEK293 cell line, pre-validated off-the-shelf AAV plasmids, and pre-qualified analytical assays, to accelerate the production of R&D and GMP-grade material required for SPG50 process validation and to assist Elpida with its Biologics License Application submission.