- JUST – EVOTEC BIOLOGICS TO PROVIDE PROCESS DEVELOPMENT REQUIRED FOR PHASE I CGMP CLINICAL MANUFACTURING OF BROADLY NEUTRALISING ANTIBODY AGAINST HIV
Hamburg, Germany, 08 June 2020:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that its Seattle-based subsidiary Just – Evotec Biologics, Inc. has entered into an agreement with Advanced BioScience Laboratories, Inc. (“ABL”), a global contract development and manufacturing organisation (“CDMO”) to the U.S. Government and biopharmaceutical industry. This project has been 100% funded with Federal funds under a $ 318.5 m contract from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201700010I/HHSN27200009.
Under the agreement, Just – Evotec Biologics will design a highly efficient manufacturing process required for the production of Phase I cGMP clinical supply of a broadly neutralising antibody (“bnAb”) against HIV. Just – Evotec Biologics will support ABL by designing scalable development processes capable of producing a suitably scaled production run under cGMP conditions acceptable for human clinical trials. Under the agreement, Just – Evotec Biologics will also design a product formulation suitable for clinical infusion and provide assay development and release and stability testing services.
Andrew Arrage, Sr. Vice President, Business Development at ABL, commented: “We value our partnership with Just – Evotec Biologics as our subcontractor for the development of this critical product. ABL’s collaborative partnering approach coupled with Just – Evotec Biologics’ development capabilities will enable the delivery of clinical materials by the end of 2020.”
Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: “Through the use of Just – Evotec Biologics’ technology platform, we are extremely pleased to be supporting ABL to advance this important antibody molecule targeting HIV. Our experience with bnAbs continues to inform our efforts towards the compelling goal of rapidly developing highly efficient production processes resulting in affordable biologics for broader patient access globally.”
No financial terms of the agreement were disclosed.