AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), entered into a new service agreement with Medigene AG. Under the agreement, AGC Biologics is providing autologous production for a next-generation-therapy product focused on the treatment of solid cancers, supporting Medigene’s IND filing and clinical trials.

With the product currently in the pre-clinical phase, AGC Biologics will perform a process transfer and clinical manufacturing of Medigene’s product candidate at the CDMO’s Cell and Gene Center of Excellence in Milan.

According to recent industry research from Roots Analysis, T cell immunotherapies are poised for greater than 30 percent growth rate over the next decade, thanks to their unique ability to target cancer cells and promising early clinical data. Being a living therapy, T cell therapies are complex drug products to manufacture at GMP scales. AGC Biologics’ Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects, such as these. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage.

“The growth of T cell immunotherapies in recent years has been astonishing. Although complex to manufacture, they offer unique therapeutic effects for patients in need,” said Luca Alberici, general manager of AGC Biologics Milan. “Intricate cell therapy projects are not unique to our team, and we are eager to take on this challenge and help produce this cell therapy product with Medigene, a company truly focused on innovation in the field of solid tumor treatments.”

“This is a critical first step in ensuring that our lead product candidate MDG1015, a third generation TCR-T therapy combining our optimal affinity TCR targeting NY-ESO-1/LAGE-1a with our PD1-41BB costimulatory switch protein, is ready for GMP clinical evaluation,” said Selwyn Ho, CEO at Medigene. “We are delighted to partner with AGC Biologics as we advance towards MDG1015’s phase I clinical milestone and look forward to its further development and delivering a potentially best-in-class, differentiated TCR-T therapy for patients with solid tumors.”