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AGC Biologics, Calypso Biotech sign pact for cGMP manufacturing

AGC Biologics will develop and scale up a process for cGMP manufacture of CALY-002 in its facility to support Calypso’s clinical trials in Europe.

AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and Calypso Biotech B.V. (Calypso), a biotechnology company focused on the development of novel therapeutic antibodies in the inflammation/autoimmune therapeutic areas announced that they 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 world class 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.