CDMO AGC Biologics has agreed to support Medigene with their IND filing and clinical trials to treat cancer.
Contract development and manufacturing organization (CDMO) AGC Biologics will use its cell and gene therapy (CGT) facility in Milan, Italy to provide Medigene with autologous production for its cell therapy candidate, which aims to treat cancer.
Through this deal, the CDMO aims to manufacture Medigene’s lead product candidate, a TCR-T therapy that treats solid cancers for phase I clinical trials, and help the firm reach its clinical goals by supporting any additional clinical and commercial manufacturing needs of this product.
c/o AGC Biologics
“Our Milan site has experience bringing several cell therapies to the market. In addition, the Milan site has un-matched experience dealing with regulatory authorities as we have assisted other partners to get approval for their cell therapies before,” a spokesperson for AGC Biologics told BioProcess Insider.
According to the firm, with over 30 years of experience in cell and gene therapy, the Milan facility is headed by a core team with substantial experience in development and production of CGT products.
“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.
The critical part of production, as per the reports, is generating TCR-T cells compliant with the critical quality attributes in sufficient volumes for treatment.
“Our main goal for this collaboration is to set up a large-scale closed process for the engineering and manufacturing of T cells that can guarantee to generate therapeutic doses of medicinal product, while controlling costs and the number of steps needed to produce the drug product needed for the phase I clinical trials,” said AGC Biologics.
T-cell treatments are complex to develop and manufacture; however, they offer some unique traits that can address various cancer types and are likely to benefit future clinical application of this immunotherapy.
The financials associated with this partnership have not been disclosed.
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