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- Just – Evotec Biologics will deliver an ultra-rapid, cost-efficient biotherapeutics manufacturing platform solution for the DOD’s Manufacturing Optimization Program
- Manufacturing solution includes seamless integration of accelerated mAb drug development into the overall Manufacturing Optimization Program
- Manufacturing Optimization Program effort enhances U.S. Government’s rapid response capabilities for biologics MCMs in response to emergency situations
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Hamburg, Germany, 25 June 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that its Seattle-based subsidiary, Just – Evotec Biologics, Inc., was selected by the U.S. Department of Defense (“DOD”) to develop an accelerated monoclonal antibody (“mAb”) development and manufacturing solution for the DOD’s Manufacturing Optimization Program. The multi-year program award, valued up to $ 39 m, will support the U.S. Government’s effort to enhance its rapid response capabilities for biologics medical countermeasures (“MCMs”).
Under the program, Just – Evotec Biologics will focus its expertise on project activities and technologies that will significantly decrease the time for development, manufacturing, and CMC-focused regulatory efforts. These innovations will significantly increase the speed to first clinical doses while maintaining high mAb quality, productivity, and safety criteria. Activities include developing and testing process development optimization, improving efficiencies in cGMP manufacturing and drug product release, and enhancing operational and resource workflows. The program will culminate in testing the optimized system components through rapid response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.
The Just – Evotec Biologics’ optimized manufacturing solution will seamlessly integrate into the U.S. Government’s rapid emergency response system spanning the entire drug development lifecycle, with an overall 100-calendar day target timeline for advancing drug development from pathogen identification through fielding of doses.
Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics stated: “We are proud to be selected to provide our expertise and technologies in support of this important program. We are excited to push our current end-to-end biologics development platform and partner with the DOD to bring ‘next level’ development of fast, high quality, cost efficient mAbs to the clinic.”
Dr Matthias Evers, Chief Business Officer of Evotec, commented: “It is an honor to further support and expand our work for the DOD with this program of strategic importance that could bring further innovation in mAb development and manufacturing to the industry. We strongly believe that by focusing on the design and application of innovative technologies we will dramatically expand global access to biotherapeutics.”
Mr. Bruce Goodwin, Joint Project Lead at JPEO-CBRND (JPL for CBRND Enabling Biotechnologies): “The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is thrilled to reinforce its collaboration with Just – Evotec Biologics in the context of an innovative program. This strategic alliance enables us to harness the power of advancements in manufacturing as part of our readiness and agile reaction approach, ensuring that we are prepared to swiftly develop medical countermeasures in response to a diverse array of biologic threats.”
The contract was awarded to Just – Evotec Biologics by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Joint Product Lead for Enabling Biotechnologies (JPL CBRND EB) under contract number MCDC2301-001.
Prior contracts awarded to Just – Evotec Biologics by the DOD include the COVID project, which enabled the manufacture of doses under tight timelines and restricted resourcing, and Accelerated Antibodies, which focuses on mAb prophylactic therapies for Plague and Orthopoxviruses.
About the Manufacturing Optimization Program
The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense requires innovative approaches that can accelerate the drug development lifecycle through production and delivery. Under this prototype project, the United States Government (“USG”) is seeking optimized manufacturing platforms and techniques that can be seamlessly incorporated into an integrated emergency response system that covers the entire drug development lifecycle. Innovative manufacturing solutions will support an overall 100-calendar-day target timeline for advancing drug development from pathogen identification through fielding of doses. This is necessary, due to a dynamically changing chemical/bioweapons threat landscape and increasing potential that the war fighter may encounter unanticipated threats in the field. Further, drug development timelines are historically lengthy, limiting response capabilities in an emergency scenario. The primary objective of this effort is to identify, develop and demonstrate optimized manufacturing platforms/techniques that can enhance the USG’s rapid response capabilities for biologics MCMs.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.
About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.
Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
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