Evotec has moved an investigational orthopoxvirus antibody program into the clinic, with its biologics development and manufacturing arm, Just – Evotec Biologics, initiating a Phase 1 study of the monoclonal antibody cocktail JST-018.

The candidate is being developed through the U.S. Department of War’s Accelerated Antibodies Program and is intended as a potential preventive countermeasure for people who could be exposed to orthopoxviruses, including military personnel facing elevated biological-threat risks.

The start of human testing follows a development program that encompassed candidate selection, preclinical work, manufacturing-process development, regulatory activities and production of clinical-trial material.

JST-018 was manufactured at Just – Evotec Biologics’ J.POD® facility in Redmond, Washington, using the company’s continuous bioprocessing technology. The development model allowed the company to carry the program through multiple stages within an integrated framework, from antibody sequence selection through production of material suitable for clinical evaluation.

Linda Zuckerman, PhD, EVP Global Head of Just – Evotec Biologics, says the program demonstrates how the company’s continuous manufacturing platform can support the transition of biologic candidates into clinical development. She adds that collaboration with the U.S. government enabled the company to manufacture and supply JST-018 as a medical countermeasure under the Accelerated Antibodies Program.

For biodefense applications, manufacturing flexibility and speed can be particularly important. Just – Evotec Biologics is positioning its continuous-production platform as a way to reduce development timelines while establishing a scalable manufacturing approach for biologic countermeasures.

Orthopoxviruses include several clinically and strategically important pathogens. The family encompasses variola virus, which causes smallpox, along with the virus responsible for mpox. Although smallpox was eradicated, orthopoxviruses remain an area of interest for biodefense planning and public health preparedness. JST-018 is being studied as a prophylactic approach intended to help protect individuals considered to be at increased risk of exposure.

The orthopoxvirus project represents the second Just – Evotec Biologics program conducted under the Department of War’s Accelerated Antibodies Program. The company received an earlier award in 2022 to support monoclonal antibody development against plague. Evotec has said the two previously announced programs have a combined potential contract value of up to $123.9 million.

The orthopoxvirus agreement was awarded in 2023 by the 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). The program operates through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority under contract MCDC2203-001.

With JST-018 now entering Phase 1, the program provides a clinical-stage example of Just – Evotec Biologics’ strategy of integrating antibody development with continuous manufacturing and regulatory execution. The approach could be relevant to future biodefense programs where both rapid development and the ability to scale production are critical.

The newly initiated Phase 1 trial will provide the first clinical assessment of JST-018 in humans. The study is registered with ClinicalTrials.gov under NCT07595458.