Calypso Biotech Completes CALY-002 Clinical Batch Manufacturing

AGC Biologics produces humanized monoclonal antibody targeting IL-15

SEATTLE,June 18,2020 --AGC Biologics,a global biopharmaceutical Contract Development Manufacturing Organization (CDMO),produces a GMP-grade clinical batch of CALY-002 for Calypso Biotech. The immunotherapy biotech company retained the services of AGC Biologics for the development of the manufacturing process and the production of its clinical supply.

IL-15 is an immune checkpoint cytokine that controls inflammation,as well as the fate of multiple immune cells. 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. 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," says Calypso's CEO Alain Vicari.

"AGC Biologics is pleased to be working with Calypso Biotech on this innovative monoclonal antibody product," says 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."

About Calypso Biotech:

Calypso Biotech is an immunotherapy biotech company,spin-off from Merck Serono,that discovers and develops monoclonal antibodies for the treatment of immune pathologies with large,unmet medical needs. Calypso Biotech is headquartered in Amsterdam,the Netherlands,with offices and laboratories in Geneva,Switzerland,and is also a resident company of Johnson & Johnson Innovation -JLABS (JLABS @ BE) in Beerse,Belgium,a premier life science incubator program. For more information on Calypso Biotech,please see www.calypsobiotech.com.

About AGC Biologics:

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1000 employees worldwide. AGC Biologics' global network spans three continents,with cGMP-compliant facilities in Seattle,Washington; Boulder,Colorado; Copenhagen,Denmark; Heidelberg,Germany; and Chiba,Japan.

AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics,from pre-clinical to commercial mammalian and microbial production. Integrated service offerings include plasmid (GMP pDNA) manufacturing,cell line development,bioprocess development,formulation,analytical testing,antibody drug development and conjugation,cell banking and storage and protein expression,including the proprietary CHEF1® Expression System for mammalian production.

Learn more at www.agcbio.com.

Logo - http://cusmail.com/res/2023/07-22/19/19cae39a3b9e8b5cbd253f4d47446d35.jpg