Nippon Shinyaku and Atsena Therapeutics Enters into Collaboration for ATSN-101 in the U.S. and Japan
Thursday, November 14, 2024
Nippon Shinyaku and Atsena Therapeutics have entered into an exclusive licencing agreement focused on the commercialisation and development of ATSN-101, an investigational gene therapy for Leber congenital amaurosis (LCA1) caused by biallelic mutations in GUCY2D.
Under this agreement, Nippon Shinyaku gains exclusive rights for commercialisation in the U.S. and development and commercialisation in Japan, while Atsena retains commercial rights outside these regions.
ATSN-101, a first-in-class, subretinal AAV5 gene therapy, has been designated by the U.S. Food and Drug Administration (FDA) as a Rare Paediatric Disease treatment, with Regenerative Medicine Advanced Therapy and Orphan Drug designations.
Currently being evaluated in an ongoing Phase I/II clinical trial, ATSN-101 has shown durable and clinically meaningful vision improvements at the high dose at the 12-month follow-up and is well-tolerated.
Should Atsena receive a Rare Paediatric Disease Priority Review Voucher (PRV) following the approval of the Biologic Licence Application for ATSN-101, Atsena will maintain ownership and full rights to the PRV. This innovative therapy presents a significant potential treatment option for LCA1, an area currently lacking approved solutions.
Source: globenewswire.com
