On September 20, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the U.S. Department of Defense ("DOD") has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody ("mAb")-based drug product prototypes targeting plague (Press release, Evotec, SEP 20, 2022, View Source;evotec-biologics-awarded-contract-from-us-department-of-defense-under-accelerated-antibodies-program-6213 [SID1234619677]). Plague, an infectious disease caused by the bacterium Yersinia pestis ("Y. pestis"), is one of the designated targets of interest under the DOD’s Accelerated Antibodies Program .
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Under the contract, Just – Evotec Biologics will develop mAb-based drug product prototype(s) from sequence discovery or evaluation of existing mAbs to completion of Phase I first-in-human ("FIH") clinical trials. To enable rapid development, Just – Evotec Biologics will leverage its data-driven, highly automated end-to-end biologics technology platform, J.DESIGN, that includes; antibody discovery (J.HAL), molecular optimisation, cell line and process development, and continuous manufacturing at its J.POD Redmond, Washington (US) facility. In addition, Evotec will provide pre-clinical and clinical capabilities for mAb prophylactic approvals.
The rapid, cost-efficient development of mAb product protypes will yield an accelerated supply of safe and efficacious mAb medical counter measures ("MCMs") for use against plague.
J.DESIGN employs a series of innovative technologies relying on the use of artificial intelligence, machine learning, intensified and continuous bioprocesses specifically designed for flexible and efficient biologics development, from discovery through to clinical and commercial manufacturing. The advanced Just – Evotec Biologics platform is specifically well suited for monoclonal antibodies as well as other protein modalities such as Fc fusion proteins.
Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics commented: "It is an honor to continue our partnership with the JPEO-CBRND team in this new effort to support the DOD’s Accelerated Antibodies program. We are pleased to provide a single integrated discovery, development and manufacturing solution for the DOD."
Dr Craig Johnstone, Chief Operating Officer of Evotec, added: "We are delighted to support the DOD with this work of strategic national importance, and which we feel represents a clear validation of both the efficiency and speed our leading science, technology and expertise offers our partners."
Mr. Bruce Goodwin, Joint Project Lead for CBRND Enabling Biotechnologies, added: "JPEO-CBRND-EB is pleased to work with Just/Evotec on this innovative and significant program to protect the Warfighter. Just/Evotec brings a unique approach, a robust toolset and deep expertise to address a challenging threat in a highly accelerated time frame."
The contract was awarded by the Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND-EB) within the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). Contract number MCDC2203-001.
Just – Evotec Biologics’ J.POD Redmond, Washington biologics development and cGMP manufacturing facility will develop mAb-based drug products for the US Department of Defense. The state-of-the-art facility is joining the DOD’s Advanced Development and Manufacturing network of facilities, providing DOD with the space and tools necessary to rapidly produce quality medical countermeasures at the lowest possible cost of goods.