#United States #Redmond #Antibodies #Just - Evotec #orthopoxvirus

Just - Evotec Biologics Begins Phase 1 Clinical Trials for Orthopoxvirus Antibodies

Just - Evotec Biologics has marked a significant milestone in its battle against high-priority biological threats by initiating a first-in-human Phase 1 clinical trial. This trial focuses on JST-018, a cocktail of investigational monoclonal antibodies that target orthopoxviruses, such as the notorious variola virus, responsible for smallpox. This development is part of the U.S. Department of War's Accelerated Antibodies Program, reflecting a collaborative effort towards enhancing biodefense capabilities against these viral threats.

The transition from research and development to clinical trials represents a substantial achievement for Just - Evotec Biologics. The company has efficiently advanced the orthopoxvirus program, covering the spectrum of antibody sequence selection, preclinical development, process development, and regulatory submission. Furthermore, the entire process culminated in the cGMP manufacturing of clinical trial materials, which were produced at Just - Evotec’s state-of-the-art J.POD® facility located in Redmond, Washington.

Linda Zuckerman, PhD, the Global Head of Just - Evotec Biologics, noted, “This program exemplifies the power of our integrated continuous manufacturing platform for biologics to advance seamlessly from sequence optimization to clinical evaluation.” The urgency of this project is underscored by the pressing need for medical countermeasures as they are intended to protect warfighters who might be exposed to such biological risks.

Orthopoxviruses represent a significant focus for biodefense, with potential implications for public health. The successful initiation of the Phase 1 clinical trial not only supports the urgent need for effective prophylactic therapies but also showcases Just - Evotec’s innovative supply chain and manufacturing capabilities. Utilizing continuous bioprocessing platforms, the company has developed a model that can be rapidly adapted for the production of critical medical countermeasures.

Additionally, this orthopoxvirus initiative is Just - Evotec Biologics' second project under the U.S. Department of War's Accelerated Antibodies Program, following a previous study aimed at developing monoclonal antibodies against plague. The total potential value of the contracts awarded to Just - Evotec for these two projects amounts to an impressive $123.9 million, highlighting the government’s commitment to enhancing the nation’s biodefense arsenal.

The contract for the orthopoxvirus program was awarded in 2023 by the U.S. Department of War's Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE-CBRND), in concert with the Biomedical Advanced Research and Development Authority (BARDA). It is worth noting that references to the Department of War and its subdivisions do not implicitly endorse the program by the U.S. government.

More detailed information about the clinical study will be accessible on ClinicalTrials.gov under identifier NCT07595458. The advancement illustrates Just - Evotec Biologics’ commitment to leveraging cutting-edge technologies and processes to develop effective biotherapeutics that address significant health threats.

About Just - Evotec Biologics

Just - Evotec Biologics, a subsidiary of Evotec SE, is a pioneering biologics platform that adopts advanced AI and machine learning technologies. The company’s expertise spans molecular design, cell line development, and continuous manufacturing processes designed to streamline the journey from drug discovery to clinical application.

Just - Evotec aims to break down scientific and economic barriers in the development of protein therapeutics, striving to enhance accessibility through innovative science and technology. For more information about their initiatives, visit Just - Evotec Biologics.

About Evotec SE

Evotec is a prominent life science company redefining drug discovery and development through cutting-edge science and AI-driven innovation. By maximizing operational agility and scientific excellence, Evotec collaborates closely with pharmaceutical companies, biotechs, and healthcare stakeholders to facilitate transformative healthcare solutions.