August 12, 2015 Rentschler is responsible for providing cGMP drug substance of DX-2930 for Dyax Corp.
Company Commences Key Manufacturing Activities; On Track to Initiate Phase 3 Trial This Year
BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today 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 hereditary angioedema (HAE) attacks.
Dyax's manufacturing partner, Rentschler Biotechnologie GmbH (Rentschler), 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 Chief Executive Officer of Dyax. "Their knowledge will be important as we work to prepare the CMC (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."
DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) which is currently being developed as a subcutaneous injection for the prevention of HAE attacks. Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.
About Rentschler Biotechnologie
Rentschler is a CDMO with over 40 years proven track record in biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler's long experience covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler's customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP manufacturing to comprehensive analytics and fill & finish. Rentschler's state-of-the-art manufacturing facility includes bioreactors up to 3,000 L stainless steel and up to 2,000 L single-use. The long-term experience with international regulatory affairs complements the offerings. Rentschler's full-service concept allows flexibility on the individual project requirements. For more information, please visit www.rentschler.de.
Dyax is a biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company is developing DX-2930 for the prevention of HAE attacks. In March 2015, the Company reported positive safety, pharmacokinetic, biomarker and proof-of-concept efficacy results from its Phase 1b clinical trial of DX-2930 in HAE patients. DX-2930 has received Fast Track and Breakthrough Therapy designation from the FDA. Additionally, Dyax markets KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older.
Both DX-2930 and KALBITOR were identified using Dyax's proprietary phage display technology. Dyax has broadly licensed this technology under its Licensing and Funded Research Portfolio (LFRP). The current portfolio includes one FDA approved product, Eli Lilly and Company's CYRAMZA® (ramucirumab), for which Dyax receives royalties, and multiple product candidates in various stages of clinical development for which the Company is eligible to receive future milestones and/or royalties.
For additional information about Dyax, please visit www.dyax.com.
Rentschler Biopharma SE
Dr. Cora Kaiser
Senior Director Corporate Communication