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AGC Biologics A/S and Calypso Biotech BV Announce Agreement for Process Development and cGMP Manufacture of CALY-002

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AGC-Biologics-SMALLER-LOGO-1COPENHAGEN, Denmark and AMSTERDAM, Feb. 19, 2019 /PRNewswire/ -- 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 today 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," said Gustavo Mahler, PhD, Chief Executive Officer of 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."

"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," said Alain Vicari, DVM, PhD, Chief Executive Officer of Calypso. "The successful process development and manufacture of CALY-002 is critical to Calypso meeting our aggressive clinical development timelines."

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 https://www.calypsobiotech.com

About AGC Biologics

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a strong commitment to deliver the highest standard of service to our clients. AGC Biologics has an extensive network of cGMP facilities in the US, Europe and Asia. We offer deep industry expertise, innovative solutions and technologies, and customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial, for mammalian and microbial. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver reliable and compliant drug substance supply, on time. For more information, visit www.agcbio.com.

Calypso Biotech Media Contact Information:
Alain VICARI DVM, PhD
Chief Executive Officer
Calypso Biotech BV
Email: info@calypsobiotech.com

AGC Biologics Media Contact Information:
Diane Hunt
Head of Global Marketing
Email: dhunt@agcbio.com

AGC Biologics CEO Gustavo Mahler Featured in Interview with Global Business Reports

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AGC Biologics CEO Gustavo Mahler recently sat down with Global Business Reports to discuss our business "We find that the closer a company is to commercialization, the more agnostic they are to location. However, if a molecule is in the early stages of clinical trials, interaction between ourselves and the client is essential and so proximity becomes a more significant factor.”and his vision for our future. 

AGC Biologics was created following AGC Asahi Glass’ acquisition of Biomeva and CMC Biologics. Could you provide an overview of how the three organizations have been integrated?  

Following the acquisitions of CMC Biologics and Biomeva, we began to identify how to integrate all entities under the single AGC Biologics brand. There are a number of challenges that come with rebranding because all stakeholders need to be accounted for. Thus, we carried out a thorough integration period across nine different streams, including operations, quality, I.T. and supply chain. We also developed a strategic plan to grow the business. We had an ambitious capital investment approach, which included expansion at our Denmark

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