Evotec SE has announced the initiation of a phase 1 clinical trial evaluating JST-018, a cocktail of investigational monoclonal antibodies targeting orthopoxviruses, developed by its biologics CDMO subsidiary Just – Evotec Biologics under the US Department of War’s accelerated antibodies programme.
Under the Accelerated Antibodies Program, Just – Evotec Biologics advanced the orthopoxvirus program from antibody sequence selection through preclinical development, process development, regulatory submission and cGMP manufacture of clinical trial materials. Manufacturing was completed at the company’s J.POD facility in Redmond, Washington, utilising its continuous bioprocessing platform.
This milestone delivers on the scope of Just – Evotec Biologics’ 2023 contract with the US Department of War to progress antibody-based drug candidates against orthopoxviruses from continuous manufacturing process development through first-in-human clinical evaluation. The investigational antibody, 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.
Orthopoxviruses include the variola virus, which causes smallpox, as well as the virus responsible for mpox. The virus family remains an important focus of biodefense and global public health preparedness. The continuous manufacturing platform at Just – Evotec Biologics provides a rapid and cost-effective approach for these important medical countermeasures.
The orthopoxvirus program is Just – Evotec Biologics’ second under the US Department of War’s accelerated antibodies programme, following an initial 2022 programme award to support the development of monoclonal antibodies against plague. Together, the two previously announced contracts have a combined potential value of up to $123.9 million.
The orthopoxvirus contract was awarded to Just – Evotec Biologics in 2023 by the US Department of War’s Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND).