Agilis Biotherapeutics, a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), and Gene Therapy Research Institution (GTRI), a corporation with the mission of developing and delivering of the safest and most efficient gene therapies, announced that the companies have completed a manufacturing and collaboration partnership joint venture (JV) to advance adeno-associated virus (AAV) gene therapies. The JV was initiated earlier this year in connection with a grant from the Japanese Ministry of Trade, Economics and Industry (METI) and Japan External Trade Organization (JETRO) for the development of a state-of-the-art AAV manufacturing facility in Japan. GTRI was co-founded by Professor Shin-ichi Muramatsu, M.D., a leading pioneer in gene therapy who has performed basic science and clinical research in the field for over two decades.

The JV, headquartered in Japan, will initially focus on developing and manufacturing AAV gene therapy vectors using Sf9 baculovirus and HEK293 mammalian cell systems and operate a process development and production facility located in the Tokyo area designed to meet international manufacturing standards, including cGMP, GCTP and PIC/S GMP requirements. Agilis and GTRI will also collaborate to expedite the development, approval and commercialization of select gene therapies in specific CNS diseases. Terms of the joint venture were not disclosed.

“We are pleased to collaborate with Agilis to leverage each organization’s capabilities and know-how, advance the manufacturing state-of-the art for gene therapy, and develop novel gene therapies,” commented Katsuhito Asai, Chief Executive Officer of GTRI and a Director of the joint venture. “Our partnership will seek to capitalize on the strong recent progress in the field of gene therapy and expedite the development of innovative gene therapies for patients in need, with a major emphasis on the quality production of safe, effective therapeutics.”

“We are thrilled to partner with GTRI,” said Mark Pykett, Agilis CEO and a Director of the joint venture. “We believe that our partnership will enhance the efforts of both organizations, build important shared production capabilities, and accelerate development and commercialization of important gene therapies. We look forward to working with GTRI on a range of initiatives.”