This termination follows unsuccessful discussions for transferring back to Lysogene the responsibility for the global commercial supply of LYS-SAF302.
The termination of the agreement will enable Lysogene to regain development and commercialization rights for LYS-SAF302 in the US and other non-EU territories as well as the responsibility for global commercial supply of LYS-SAF302, all previously granted to Sarepta.
Lysogene will be entitled to receive reimbursement for certain costs associated with the termination.
LYS-SAF302 was granted Orphan Drug Designation in the US and European Union. In the US, it also has obtained Fast Track and Rare Pediatric Disease designations.
The global, open-label, single-arm, multi-center Ph2/3 clinical trial AAVance (NCT03612869) with LYS-SAF302 is fully enrolled and fully dosed, and all patients are being monitored per study protocol.
The primary endpoint data readout of this registrational trial is expected mid-2022, as initially anticipated.
Lysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system.
The company has built a unique capability to enable a delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA is ongoing.
An adaptive clinical trial in GM1 gangliosidosis is also ongoing. Lysogene is also collaborating with an academic partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism.
Circio unveils circVec proof-of-concept
GSK releases decade-long data on Shingrix efficacy
BiVictriX receives FDA Orphan Drug Designation for AML treatment candidate
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
GSK's meningitis vaccine candidate accepted for FDA review
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
ProAxsis secures GBP1.8m investment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients