AGC Biologics and Calypso Biotech have entered into an agreement for the process development and cGMP manufacture of CALY-002, a humanized monoclonal antibody inhibiting Interleukin-15 (IL-15). Under the agreement, AGC Biologics will develop and scale up a process for cGMP manufacture of CALY-002 in its facility in Copenhagen, Denmark to support Calypso’s clinical trials in Europe.
 
IL-15 is an immune checkpoint cytokine that controls inflammation as well as the fate of multiple immune cells. Especially, IL-15 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. Calypso scientists believe that targeting tissue-resident memory T cells with CALY-002 offers significant advantages and potential in multiple autoimmune indications, including unprecedented disease-modifying effects.
 
“We are pleased to be working with Calypso on this exciting and innovative monoclonal antibody product,” said Gustavo Mahler, chief executive officer, AGC Biologics “With our extensive experience developing and manufacturing monoclonal antibody products, we are well positioned to help Calypso deliver this innovative antibody treatment to patients.”
 
Alain Vicari, chief executive officer, Calypso, said, “We selected AGC Biologics as our manufacturing partner because of their ability to support our accelerated program for CALY-002, since they have extensive experience working with monoclonal antibodies combined with their very broad development and manufacturing capabilities. The successful process development and manufacture of CALY-002 is critical to Calypso meeting our aggressive clinical development timelines.”