CDMO AGC Biologics will develop the process and manufacture Calypso’s CALY-002, a humanized monoclonal antibody manufactured in a CHO cell line, from its site in Denmark.
Calypso Biotech, a spin-off from Merck Serono, has selected contract development and manufacturing organization (CDMO) AGC Biologics for the process development and cGMP production of its lead candidate CALY-002.
The work will be undertaken at AGC Bio’s site in Copenhagen, Denmark. Financials of the deal have not been divulged, but Calypso’s CEO Alain Vicari said the decision to use AGC Bio followed a rigorous selection process.
“We went through a rigorous process of screening European CDMOs using a scoring matrix with 15 criteria ranging from expertise of the CDMO from early development up to late clinical and commercial stages, cost-effectiveness and cultural fit with Calypso Biotech, and AGC Biologics came first,” he told BioProcess Insider.
“We were very impressed by the quality and experience of their team and state of the art equipment when we visited their site in Copenhagen.”
The Danish mammalian manufacturing facility, run by CMC Biologics before the firm was acquired by Asahi Glass Company (AGC) in 2016, is based on single-use technologies. AGC Bio uses a 6Pack suite platform consisting of six 2,000 L single-use bioreactors and a 2,000 L seed train. Last August, the firm added a further 12,000 L of single-use capacity to mirror a similar facility at the firm’s Bothell, Washington site, which was installed and commissioned in 2015.
Merck Serono span-out Calypso Biotech from its Entrepreneur Partnership Program in 2013.
Lead candidate CALY-002 is a humanized IgG1 antibody and is manufactured in a CHO cell line. The MAb inhibits Interleukin-15 (IL-15), a cytokine expressed by monocytes, dendritic cells and epithelial cells.
“Interleukin-15 (IL-15) is a very important mediator in the development of the immune response,” Vicari told us. “At the moment, there are many efforts to combine IL-15 stimulation with other approaches in the booming field of immuno-oncology, with the goal to stimulate the anti-tumor response.
“On the other hand, the product we develop, CALY-002, is an antibody that neutralizes IL-15 and could potentially treat several auto-immune diseases in which IL-15 production appears to be dysregulated.”
The product is in IND enabling studies for the potential treatment of eosinophilic esophagitis, among other indications.