AGC and Calypso Agreed upon cGMP Manufacture

| By | AGC Biologics, Antibody

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.

We are pleased to be working with Calypso on this exciting and innovative monoclonal antibody product. With our extensive experience developing and manufacturing monoclonal antibody products, we are well positioned to help Calypso deliver this innovative antibody treatment to patients,

said Gustavo Mahler, PhD,
Chief Executive Officer of AGC Biologics

We selected CMC 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,

said Alain Vicari, DVM, PhD,
Chief Executive Officer of Calypso.

SOURCE: AGC Biologics
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