01/16/2025 | Press release | Distributed by Public on 01/16/2025 07:39
Today, we announced a development and manufacturing services agreement with Adaptimmune, a company working to redefine the treatment of solid tumor cancers with cell therapy. The CDMO is manufacturing the lentiviral vector used to produce letetresgene autoleucel ("lete-cel"), an engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1. Under this agreement, AGC Biologics will perform activities in support of Adaptimmune's regulatory submissions for lete-cel, including process characterization, stability studies, and manufacture and supply of vectors.
AGC Biologics previously manufactured the lentiviral vectors used in clinical trials for lete-cel. Primary analysis of its pivotal Phase 2 IGNYTE-ESO trial showed responses in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy (IGNYTE-ESO trial). Based on these positive data, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel builds on the potential of Adaptimmune's sarcoma franchise to change the way solid tumors are treated using cell therapies, more than doubling the addressable patient population eligible for Adaptimmune cell therapies to also include NY-ESO-1 positive synovial sarcoma and MRCLS solid tumors. In August 2024, Adaptimmune received the first commercial approval by the U.S. Food and Drug Administration (FDA) for an engineered cell therapy for the treatment of a solid tumor cancer.
AGC Biologics Milan is one of the few CDMOs manufacturing several products commercially approved by the main regulatory bodies, and one of the only sites in the cell and gene industry authorized to commercially produce both viral vectors and cell therapies by the FDA and European Medicines Agency (EMA). The site has a 30-year track record and unique late-stage and commercial manufacturing experience, making it one of the most accomplished cell and gene CDMO production sites in the world.
"Adaptimmune is bringing to market one of the most promising, innovative assets in the cell and gene space targeting solid tumors. After producing the viral vectors used in the clinical phases for lete-cel, we have unique insights into how to support this product's success during its commercial stages," said Luca Alberici, General Manager, AGC Biologics Milan Facility. "This site has supported 30% of all ex-vivo gene therapies commercially approved on the market today, and we will use that expertise in partnership with Adaptimmune and prepare lete-cel for this next critical phase."
"AGC Biologics has been a key partner in supporting the journey to develop, evaluate in the clinical setting, and now prepare the regulatory submissions for lete-cel," said John Lunger, Chief Patient Supply Officer, Adaptimmune. "We are excited to leverage our shared expertise with AGC Biologics to work towards obtaining FDA approval and bring our second cell therapy to market for the treatment of eligible patients."
For more information about AGC Biologics Milan, visit www.agcbio.com/facilities/milan. To learn more about AGC Biologics' global CDMO services go to www.agcbio.com.