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Will manufacture the lentiviral vector used to produce lete-cel, an engineered T-cell therapy targeting the NY-ESO-1 antigen.
January 16, 2025
By: Charlie Sternberg
Associate Editor, Contract Pharma
AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has announced a development and manufacturing services agreement with Adaptimmune, a cell therapy company focused on solid tumors.
Under the agreement, AGC Biologics will manufacture the lentiviral vector used to produce lete-cel, an engineered T-cell therapy targeting the NY-ESO-1 antigen. This support will include activities crucial for Adaptimmune’s regulatory submissions, such as process characterization, stability studies, and vector manufacturing.
AGC Biologics previously manufactured the lentiviral vectors used in clinical trials for lete-cel. Positive data from the Phase 2 IGNYTE-ESO trial, which demonstrated responses in patients with synovial sarcoma or myxoid/round cell liposarcoma, has led Adaptimmune to plan a rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) by the end of this year.
Lete-cel has the potential to significantly expand Adaptimmune’s solid tumor franchise, addressing a larger patient population. The company recently received the first FDA approval for an engineered cell therapy for a solid tumor, marking a significant milestone in the field.
AGC Biologics Milan, a key facility for this collaboration, possesses extensive experience in both viral vector and cell therapy manufacturing, having received authorizations from both the FDA and the European Medicines Agency (EMA).
“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,” added 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.”
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