Just Evotec Advances JST-018 Orthopoxvirus Cocktail To Phase 1

Just – Evotec Biologics has moved JST-018, an investigational monoclonal antibody cocktail targeting orthopoxviruses, into first-in-human Phase 1 evaluation, a milestone that validates continuous bioprocessing as a viable cGMP pathway for government-partnered biodefense manufacturing. For CDMOs and QA leads operating under biodefense contracts, the sequence-to-clinic timeline achieved at J.POD® Redmond sets a reference point for what integrated process development and regulatory submission can deliver under accelerated conditions.

JST-018 was developed under the U.S. Department of War's Accelerated Antibodies Program, awarded to Just – Evotec Biologics in 2023 by the Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND), in collaboration with BARDA, through the Medical CBRN Defense Consortium Other Transaction Authority (contract MCDC2203-001). The scope ran from antibody sequence selection through preclinical development, process development, IND-enabling regulatory submission, and cGMP manufacture of clinical trial material, all executed at the Redmond facility using the company's continuous bioprocessing platform.

Orthopoxviruses, which include variola (smallpox) and the mpox-causing virus, remain a high-priority biological threat category. JST-018 is intended as a prophylactic countermeasure for warfighters at elevated exposure risk. The program is Just – Evotec Biologics' second under the Accelerated Antibodies Program, following a 2022 award for plague monoclonal antibodies; the two contracts carry a combined potential value of up to $123.9 million.

From a manufacturing quality standpoint, the J.POD® continuous bioprocessing model compresses the timeline between cell line development and clinical batch release without sacrificing the process consistency required for 21 CFR Part 211 compliance and ICH Q10-aligned pharmaceutical quality systems. That compression is operationally significant for any CDMO managing government biodefense timelines, where speed and auditability must coexist.

Additional study details are registered on ClinicalTrials.gov under NCT07595458.

The Phase 1 readout will be the first measurable clinical signal for continuous bioprocessing applied to a biodefense antibody program at this scale under a U.S. government accelerated contract.

Source: Evotec SE via evotec.com, September 9, 2026.