Dyax Corp. has provided an update regarding its ongoing manufacturing initiatives for DX-2930. Discovered by Dyax, DX-2930 is an investigational fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of HAE attacks.
Dyax’s manufacturing partner, Rentschler Biotechnologie GmbH, is responsible for providing cGMP (Current Good Manufacturing Practice) drug substance for certain future clinical trials and commercial supply. In preparation for commercial-scale production, Rentschler has commenced characterization and validation of the DX-2930 manufacturing processes. In addition, Rentschler will also support Dyax in the preparation of its submissions to regulatory authorities for marketing approval of the product. If DX-2930 is approved, Rentschler will be responsible for producing commercial supply. Dyax and Rentschler entered into a definitive manufacturing services agreement in 2014.
“Rentschler is a leading manufacturer of FDA and EMA licensed products, has extensive expertise in high quality production of monoclonal antibodies, and an excellent track record in manufacturing products for both clinical trials and commercial markets,” said Gustav Christensen, President and CEO of Dyax. “Their knowledge will be important as we work to prepare the Chemistry, Manufacturing and Controls dossiers and other requisite regulatory filings. We look forward to initiating the Phase 3 trial for DX-2930 in HAE patients during the latter part of this year, and we expect that supportive results from this study will be the basis for our BLA submission to the FDA for marketing authorization.”
“We are extremely pleased to be working with Dyax to produce DX-2930,” said Dr. Klaus Schoepe, Vice President of Project Management at Rentschler. “We are utilizing our expertise to deliver a first-class quality product and consequently contribute to the availability of this important medicine and the improvement of the health status of patients.”