Evotec has announced the initiation of a Phase I clinical trial evaluating JST-018.
This cocktail of investigational monoclonal antibodies targeting orthopoxviruses was developed by its biologics CDMO subsidiary Just–Evotec Biologics under the US Department of War’s Accelerated Antibodies Program.
Under the Accelerated Antibodies Program, Just–Evotec Biologics advanced the orthopoxvirus programme 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’s 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.
Linda Zuckerman, PhD, EVP Global Head of Just–Evotec Biologics, said: “This program exemplifies the power of our integrated continuous manufacturing platform for biologics to advance seamlessly from sequence optimisation to clinical evaluation."
Through close collaboration with the Department of War, we manufactured and delivered JST-018 as an urgently needed medical countermeasure for the US government under the Accelerated Antibodies Program.”
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 Program, 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 $123.9m.
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) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority, under contract number MCDC2203-001.
