AGC Biologics Partners with Adaptimmune to Advance Lete-cel for Solid Tumour Cancer Treatment

• AGC Biologics has entered a development and manufacturing agreement with Adaptimmune for the production of lentiviral vectors for letetresgene autoleucel (lete-cel).

• The agreement supports Adaptimmune’s regulatory submissions for lete-cel as a treatment for advanced synovial sarcoma and MRCLS, targeting FDA approval by the end of 2025.

AGC Biologics, a global biopharmaceutical CDMO, has signed a development and manufacturing agreement with Adaptimmune to advance letetresgene autoleucel (lete-cel), an engineered TCR T-cell therapy targeting NY-ESO-1 positive solid tumours. The agreement includes process characterisation, stability studies, and manufacturing activities to support Adaptimmune’s regulatory submissions.

Adaptimmune aims to file a rolling Biologics License Application (BLA) with the FDA by the end of 2025, based on positive results from the Phase 2 IGNYTE-ESO trial. This pivotal study showed responses in patients with synovial sarcoma or MRCLS who had undergone prior anthracycline-based therapy. With this new milestone, Adaptimmune looks to expand its reach in the sarcoma treatment space, significantly increasing the eligible patient population.

The Milan site of AGC Biologics, a CDMO with over 30 years of experience, is central to this collaboration. It is one of the few facilities authorised by both the FDA and EMA for the commercial production of viral vectors and cell therapies. This site has supported 30% of all ex-vivo gene therapies commercially approved to date, underlining its expertise in advanced therapies.

“Adaptimmune is bringing to market one of the most promising, innovative assets in the cell and gene space targeting solid tumours,” said Luca Alberici, General Manager of AGC Biologics Milan Facility. “We will use our unique insights and extensive expertise to prepare lete-cel for its next critical phase.”

John Lunger, Chief Patient Supply Officer at Adaptimmune, echoed the sentiment, highlighting the long-standing partnership: “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.”