- JUST – EVOTEC BIOLOGICS TO PROVIDE PROCESS DEVELOPMENT REQUIRED FOR PHASE I CGMP CLINICAL MANUFACTURING OF BROADLY NEUTRALISING ANTIBODY AGAINST HIV
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.
ABOUT ADVANCED BIOSCIENCE LABORATORIES, INC.
A leading CDMO and CRO harnessing decades of pioneering science and manufacturing expertise to drive the development of innovative therapies and vaccines. ABL has extensive experience working with diverse organizations—including industry, government and academic entities—to support their quest in improving public health. ABL maintains global GMP facilities meeting U.S. and European regulatory standards, providing GMP manufacture of virus-based oncolytic therapies, gene therapies, vaccines and protein-based immunotherapeutic products. ABL’s CDMO services include bulk drug substance, fill/finish of drug product, process and assay development, and bioanalytical testing. ABL is part of the French bioindustrial group Institut Mérieux, which fights against infectious diseases and cancers, through the complementary approaches of its companies in the fields of diagnosis, immunotherapy, food safety and nutrition.
For more information visit www.ablinc.com or contact us.
Media Contact Advanced Bioscience Laboratories, Inc:
Kathy A. Williams
Director, Global Strategy & Marketing
ABOUT JUST – EVOTEC BIOLOGICS
Just – Evotec Biologics wholly owned by Evotec SE is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio.
ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.
FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.