JST-018 Orthopoxvirus Antibody Cocktail Advances Into First-in-Human Phase 1 Trial Under U.S. Department of War Program
核心洞察
Just – Evotec Biologics (搜索) initiated a first-in-human Phase 1 trial of JST-018 (搜索), an investigational monoclonal antibody cocktail targeting orthopoxviruses, under the U.S. Department of War (搜索)'s Accelerated Antibodies Program.
JST-018 (搜索) is being developed as a prophylactic therapy to protect warfighters at elevated risk of exposure to biological threats, including the variola virus that causes smallpox (搜索) and the mpox (搜索) virus.
The program advanced from antibody sequence selection through cGMP manufacture at the J.POD facility in Redmond, Washington, using continuous bioprocessing rather than batch manufacturing.
Just – Evotec Biologics (搜索), a wholly owned subsidiary of Evotec SE, has initiated a first-in-human Phase 1 clinical trial evaluating JST-018 (搜索), a cocktail of investigational monoclonal antibodies targeting orthopoxviruses. The program was developed under the U.S. Department of War (搜索)'s Accelerated Antibodies Program, with the trial registered on ClinicalTrials.gov under NCT07595458.
JST-018 (搜索) 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 (搜索), as well as the virus responsible for mpox (搜索), and the virus family remains an important focus of biodefense and global public health preparedness.
A Single-Site, Continuous Manufacturing Path
Under the Accelerated Antibodies Program, Just – Evotec Biologics (搜索) advanced the orthopoxvirus (搜索) 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, utilizing its continuous bioprocessing platform rather than batch manufacturing.
This milestone delivers on the scope of Just – Evotec Biologics (搜索)' 2023 contract with the U.S. Department of War (搜索) to progress antibody-based drug candidates against orthopoxviruses from continuous manufacturing process development through first-in-human clinical evaluation.
Linda Zuckerman, PhD, EVP Global Head of Just – Evotec Biologics (搜索), said: "This program exemplifies the power of our integrated continuous manufacturing platform for biologics to advance seamlessly from sequence optimization to clinical evaluation. Through close collaboration with the Department of War, we manufactured and delivered JST-018 (搜索) as an urgently needed medical countermeasure for the U.S. government under the Accelerated Antibodies Program."
A Prophylactic Strategy Distinct From Existing Therapies
The prophylactic intent of JST-018 (搜索) shapes the trial's purpose differently from a typical therapeutic program. Tecovirimat (TPOXX) was approved by the FDA in 2018 for treatment of smallpox (搜索) 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 continuous manufacturing platform at Just – Evotec Biologics (搜索) provides a rapid and cost-effective approach for these medical countermeasures. 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.
Second Program Under the Accelerated Antibodies Program
The orthopoxvirus (搜索) program is Just – Evotec Biologics (搜索)' second under the U.S. Department of War (搜索)'s Accelerated Antibodies Program, following an initial 2022 program award to support the development of monoclonal antibodies against plague (搜索). Together, the two previously announced contracts have a combined potential value of up to $123.9 million.
The orthopoxvirus (搜索) contract was awarded to Just – Evotec Biologics (搜索) in 2023 by the U.S. Department of War (搜索)'s Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND), in collaboration with the Biomedical Advanced Research and Development Authority (BARDA (搜索)), through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority, under contract number MCDC2203-001.
Broader Implications for Continuous Manufacturing
The Phase 1 readout will carry weight beyond JST-018 (搜索) itself. The 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 that the Department of War and BARDA (搜索) can point to when structuring future CBRN countermeasure contracts.