- Evotec SE has initiated a Phase 1 clinical trial of JST-018, an investigational monoclonal antibody cocktail targeting orthopoxviruses.
- Its biologics CDMO subsidiary, Just – Evotec Biologics, advanced JST-018 from antibody sequence selection through cGMP manufacturing at its J.POD® facility in Redmond, Washington.
Evotec SE has initiated a Phase 1 clinical trial evaluating JST-018, an investigational cocktail of monoclonal antibodies targeting orthopoxviruses. The program was developed by Evotec’s biologics CDMO subsidiary, Just – Evotec Biologics, under the U.S. Department of War’s Accelerated Antibodies Program. JST-018 is being developed as a prophylactic therapy intended to help protect warfighters who may face an elevated risk of exposure to biological threats.
Just – Evotec Biologics advanced the program from antibody sequence selection through preclinical development, process development, regulatory submission and cGMP manufacturing of clinical trial materials. Manufacturing was completed at the company’s J.POD facility in Redmond, Washington, using its continuous bioprocessing platform.
The milestone fulfills the scope of a 2023 contract with the U.S. Department of War to advance antibody-based drug candidates against orthopoxviruses from continuous manufacturing process development through first-in-human clinical evaluation. The company said its continuous manufacturing platform is designed to provide a rapid and cost-effective approach for medical countermeasures.
Orthopoxviruses include variola virus, which causes smallpox, and the virus responsible for mpox. The orthopoxvirus program is Just – Evotec Biologics’ second program under the Accelerated Antibodies Program, following a 2022 award for monoclonal antibodies against plague. The two contracts have a combined potential value of up to $123.9 million.
“This program exemplifies the power of our integrated continuous manufacturing platform for biologics to advance seamlessly from sequence optimization to clinical evaluation. The company manufactured and delivered JST-018 as a medical countermeasure for the U.S. government under the program.”
Linda Zuckerman, PhD, EVP Global Head of Just – Evotec Biologics
