AGC Biologics has signed an agreement with Adaptimmune to manufacture the lentiviral vector for letetresgene autoleucel (lete-cel), a cell therapy targeting solid tumor antigen NY-ESO-1.
The Milan, Italy site will handle process characterization, stability studies, and supply vectors to support regulatory submissions for lete-cel.
Lete-cel, developed for advanced synovial sarcoma and myxoid/round cell liposarcoma (MRCLS), showed positive results in the Phase 2 IGNYTE-ESO trial, with responses from patients who previously underwent anthracycline-based therapy.
Adaptimmune plans to begin a rolling Biologics License Application (BLA) submission by the end of 2025, aiming to expand treatment options for NY-ESO-1 positive tumors.
AGC Biologics’ Milan site, authorized by both the FDA and EMA for viral vector and cell therapy production, previously supplied vectors for lete-cel’s clinical trials. Its 30-year history and expertise in cell and gene therapy manufacturing position it to support lete-cel’s commercial development, according to the company.
Adaptimmune and AGC Biologics have collaborated throughout the therapy’s development, with AGC Biologics now preparing the manufacturing processes needed for regulatory approval. If approved, lete-cel will become Adaptimmune’s second cell therapy for treating solid tumors.