Calypso Biotech Completes CALY-002 Clinical Batch Manufacturing

Calypso Biotech is retaining the services of AGC Biologics for the development of the manufacturing process and the production of its clinical supply of GMP-grade CALY-002.

IL-15 is an immune checkpoint cytokine that controls inflammation, as well as the fate of multiple immune cells. It was recently recognized as a key factor in the survival of tissue-resident memory T cells, a population of immune cells involved in disease maintenance and recurrence. AGC Biologics has successfully developed the process and scaled up CALY-002 for cGMP manufacturing at its world class facility in Copenhagen, Denmark, to support Calypso Biotech's clinical trials. The first GMP material is now available and will be used in the first clinical trial of CALY-002.

"Calypso Biotech has achieved a new critical milestone in the development of CALY-002, thanks to an excellent collaboration with AGC Biologics. This will allow us to test the safety and efficacy of CALY-002 in clinical trials and takes us one step closer to bringing a very innovative medicine to patients in need," said Calypso's CEO Alain Vicari.

"AGC Biologics is pleased to be working with Calypso Biotech on this innovative monoclonal antibody product," commented AGC Biologics CEO Patricio Massera. "With our extensive experience developing and manufacturing monoclonal antibody products, we are well positioned to help deliver this antibody treatment to patients."