Evotec Initiates Phase 1 Trial for Orthopoxvirus Antibodies

Evotec SE, a biotechnology company, has announced the initiation of a Phase 1 clinical trial for JST-018, a cocktail of monoclonal antibodies targeting orthopoxviruses. Developed under the U.S. Department of War's Accelerated Antibodies Program, JST-018 is part of Evotec's efforts to counteract orthopoxviruses, a family of viruses that includes the variola virus responsible for smallpox. This development marks a significant step in the company's commitment to biodefense preparedness.

Just, Evotec Biologics, Evotec's biologics contract development and manufacturing organization (CDMO) subsidiary, has advanced the orthopoxvirus program from antibody sequence selection through preclinical development, process development, regulatory submission, and manufacturing. The antibodies were produced at the company's J.POD® facility in Redmond, Washington, using its continuous bioprocessing platform. This scalable model for development and continuous manufacturing is designed to ensure a rapid response to biodefense threats.

"This program exemplifies the power of our integrated continuous manufacturing platform for biologics," said Linda Zuckerman, PhD, EVP Global Head of Just, Evotec Biologics. "Through close collaboration with the Department of War, we manufactured and delivered JST-018 as an urgently needed medical countermeasure for the U.S. government."

The orthopoxvirus program is Just, Evotec Biologics' second under the U.S. Department of War's Accelerated Antibodies Program. The first program, announced in 2022, aimed to develop monoclonal antibodies against plague. Together, the two programs have a combined potential value of up to $123.9 million. The current contract 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 collaboration with the Biomedical Advanced Research and Development Authority (BARDA), through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority.

The Phase 1 clinical trial for JST-018 is being conducted to evaluate the safety and tolerability of the investigational antibody in healthy human volunteers. The trial, registered on ClinicalTrials.gov with identifier NCT07595458, is expected to provide valuable data that will support the further development of JST-018 as a prophylactic therapy for individuals at high risk of exposure to orthopoxviruses.

Just, Evotec Biologics, headquartered in Seattle and Hamburg, is a first-to-industry biologics platform company that leverages artificial intelligence and machine learning technologies, along with advanced protein and process sciences, to accelerate the development of biotherapeutics. The company's continuous manufacturing platform is designed to improve the efficiency and scalability of biologics production, making it a key player in the biodefense and biotechnology sectors.

The development of JST-018 and its advancement into clinical trials represents a significant milestone in Evotec's ongoing efforts to address emerging biological threats. As a leading biotechnology company, Evotec is committed to leveraging its expertise in biologics development and manufacturing to contribute to global health security and defense preparedness.