Just – Evotec Biologics, the Seattle-based biologics contract development and manufacturing organization (CDMO) subsidiary of Evotec SE, has advanced an investigational monoclonal antibody cocktail targeting orthopoxviruses into a first-in-human Phase 1 clinical study.

The candidate, JST-018, was developed under the U.S. Department of Defense’s Accelerated Antibodies Program. Just – Evotec Biologics supported the program from antibody sequence selection through preclinical development, process development, regulatory submission, and cGMP manufacturing of clinical trial material, according to the announcement.

Manufacturing was completed at the CDMO’s J.POD facility in Redmond, Washington, using the company’s continuous bioprocessing platform. The 2023 contract calls for development of antibody-based candidates against orthopoxviruses through continuous manufacturing process development and first-in-human clinical evaluation.

JST-018 is being developed as a prophylactic therapy intended to protect against orthopoxvirus exposure. The virus family includes variola virus, which causes smallpox, as well as the virus responsible for mpox.

The orthopoxvirus program is the second Just – Evotec Biologics project under the Accelerated Antibodies Program. An earlier program, awarded in 2022, supports development of monoclonal antibodies against plague. The two contracts have a combined potential value of up to $123.9 million, according to the company.

The Phase 1 milestone follows the June launch of the company’s J.TRAIN platform, which provides modular cleanrooms, manufacturing equipment, process automation, and technology licensing for deployment of its continuous biologics manufacturing technology in partner-owned facilities. The company said the platform can produce more than 500 kilograms of drug substance in less than 10,000 square feet of cleanroom space.

In March, Just – Evotec Biologics also received a BARDA agreement valued at up to $10 million to optimize manufacturing processes for monoclonal antibodies targeting Ebola virus disease and Sudan virus. That program focuses on molecular optimization, cell line development, and process development for two antibodies intended for scalable manufacturing.¸