A first-in-human trial of JST-018, a monoclonal antibody cocktail targeting orthopoxviruses, started this month under a 2023 contract worth up to $123.9 million combined across two biodefense programs that Just – Evotec Biologics holds with the U.S. Department of War. The speed matters: the company moved JST-018 from antibody sequence selection through preclinical development, process development, regulatory filing, and cGMP manufacture entirely at its J.POD facility in Redmond, Washington, using continuous bioprocessing rather than batch manufacturing. That single-site, single-platform path is the actual test case here, not just the antibody.
JST-018 is intended as a prophylactic for warfighters at elevated biological threat exposure risk, which shapes the trial’s purpose differently from a typical therapeutic program. Orthopoxviruses include variola, the cause of smallpox, and the mpox virus. Tecovirimat (TPOXX) was approved by the FDA in 2018 for treatment of smallpox under the Animal Efficacy Rule, but the military’s interest in a prophylactic antibody cocktail reflects a different protective strategy, one aimed at exposure before disease onset rather than after. The Phase 1 study is registered at ClinicalTrials.gov under NCT07595458.
This orthopoxvirus program is the second Just – Evotec Biologics has advanced under the Accelerated Antibodies Program. The first, awarded in September 2022 and valued at up to $49.9 million, targeted plague. The combined ceiling across both contracts is $123.9 million. What the company is building, contract by contract, is a replicable CDMO model for biodefense: take a sequence, run it through a continuous manufacturing platform, clear regulatory submission, and deliver clinical material without spinning up a separate facility for each threat agent.
The Phase 1 readout will carry weight beyond JST-018 itself. FDA’s Q13 guidance on continuous manufacturing created a regulatory framework for this kind of process, but real clinical data generated through it for biodefense antibodies remain sparse. If JST-018 clears Phase 1 safety, the Redmond platform gains a validated case study the Department of War and BARDA can point to when structuring future CBRN countermeasure contracts.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
