The Department of Defense (DOD) has turned to Evotec’s Just – Evotec Biologics subsidiary several times over the last few years to help combat various virus and bacterial threats including COVID-19, mpox and the bubonic plague (Yersinia pestis) with new antibodies to add to the U.S.' medical countermeasure stockpile.
Now, with a multiyear award worth up to $39 million, the drugmaker is tasked with a larger-scale manufacturing solution as a part of the DOD’s Manufacturing Optimization Program.
Through the program, Just – Evotec Biologics will create a sped-up monoclonal antibody (mAb) development and manufacturing framework that should bolster the government’s rapid response capabilities for biologics medical countermeasures, according to an Evotec press release.
More specifically, the Seattle-based Evotec subsidiary will work on different components of a bigger “solution” that will “significantly” reduce the time for development, manufacturing and chemistry, manufacturing and controls-related regulatory efforts and accelerate first clinical doses.
Once complete, the program will eventually test the newly optimized system through rapid response exercises, including a DOD-identified MCM antibody sequence, before ending in the manufacturing of clinical doses.
All told, Just – Evotec Biologics' contributions are meant to “seamlessly” fit into the government’s rapid emergency response system, which encompasses the entire drug development life cycle, with a 100-day target timeline for “advancing drug development from pathogen identification through fielding of doses.”
Just – Evotec Biologics is “excited” to “push our current end-to-end biologics development platform and partner with the DOD to bring ‘next level’ development of fast, high quality, cost efficient mAbs to the clinic,” global head of biotherapeutics Linda Zuckerman, Ph.D., said in the release.
“We strongly believe that by focusing on the design and application of innovative technologies we will dramatically expand global access to biotherapeutics,” Evotec’s chief business officer Matthias Evers, M.D., added.
The “strategic alliance” allows the DOD to “harness the power of advancements in manufacturing as part of our readiness and agile reaction approach, ensuring that we are prepared to swiftly develop medical countermeasures in response to a diverse array of biologic threats,” joint project lead Bruce Goodwin said.
Evotec is a familiar go-to for the government’s medical countermeasures needs. Last year, the DOD devoted $74 million to the “rapid development” of prototype candidates targeting orthopoxvirus through Evotec’s J. DESIGN CDMO platform. Before that, in 2022, the German drugmaker secured a $50 million contract to make antibodies for the bacterium Yersinia pestis, or the bubonic plague, and in 2020 was tapped to develop mAbs for COVID.
Outside of the federal government, Just – Evotec Biologics linked up with Sandoz last year to develop and manufacturer its biosimiliar candidates over multiple years.