Just - Evotec Biologics Advances U.S. Department of War Antibodies Against Orthopoxvirus into Phase 1 Clinical Studies

Just – Evotec Biologics moves its orthopoxvirus antibody cocktail JST-018 into Phase 1, advancing a U.S. biodefense contract worth up to $123.9 million.

Rhea-AI Summary

Evotec (EVO) has initiated a first-in-human Phase 1 trial of JST-018, a cocktail of investigational monoclonal antibodies targeting orthopoxviruses, developed by its CDMO subsidiary Just – Evotec Biologics under the U.S. Department of War's Accelerated Antibodies Program.

The program advanced from antibody sequence selection through preclinical work, process development, regulatory submission and cGMP manufacturing of clinical material at the J.POD® Redmond, Washington, continuous bioprocessing facility. This milestone fulfills the scope of a 2023 U.S. Department of War contract to progress antibody-based countermeasures against orthopoxviruses into first-in-human evaluation. JST-018 is being developed as a prophylactic therapy for warfighters at elevated risk from biological threats. Together with a prior 2022 plague antibody award, Just – Evotec Biologics’ two contracts under the program have a combined potential value of up to $123.9 million.

Positive

• Phase 1 trial initiated for orthopoxvirus antibody cocktail JST-018 under the U.S. Department of War Accelerated Antibodies Program
• End-to-end development completed from sequence selection through cGMP manufacturing at the J.POD® Redmond continuous bioprocessing facility
• Delivers on 2023 contract scope to advance orthopoxvirus antibody countermeasures into first-in-human clinical evaluation
• Two biodefense contracts under the Accelerated Antibodies Program have a combined potential value of up to $123.9 million

Negative

• None.

Market Context

A prior 0.41% 24-hour reaction followed Evotec’s March Phase 1 milestone, while a 1.25% reaction fol...

Analysis

A prior 0.41% 24-hour reaction followed Evotec’s March Phase 1 milestone, while a 1.25% reaction followed a December Phase 2 start, providing relevant historical context for this clinical initiation.

Key Figures

Clinical trial phase: Phase 1 Combined contract potential: up to $123.9 million Contract year: 2023

Clinical trial phase

Phase 1

JST-018 first-in-human study

Combined contract potential

up to $123.9 million

two previously announced U.S. Department of War contracts

Contract year

2023

orthopoxvirus contract award

Previous Clinical trial Reports

2 past events · Latest: Mar 19

Same Type 2 events

1. Mar 19

   Phase 1 milestone

   24h Move

   +0.4%

   Bristol Myers Squibb initiated Phase 1 study, triggering a $10 million milestone payment.

2. Dec 04

   Phase 2 study start

   24h Move

   +1.3%

   Bayer initiated Phase 2 study of monoclonal antibody BAY 3401016 for Alport syndrome.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

first-in-human, monoclonal antibodies, prophylactic therapy, cgmp, +1 more

5 terms

first-in-human medical

"First-in-human Phase 1 study initiated for investigational antibodies"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

monoclonal antibodies medical

"a cocktail of investigational monoclonal antibodies targeting orthopoxviruses"

Monoclonal antibodies are lab-made proteins designed to bind a single, specific target on cells or viruses, like identical keys cut to fit one lock. They are used as medicines, tests, or targeted delivery tools and can precisely block or mark disease processes. Investors care because they can become high-value drugs with large sales, long patent protection, and binary risks tied to clinical trial results, regulatory approval, manufacturing scale and pricing.

prophylactic therapy medical

"being developed as a prophylactic therapy intended to help protect warfighters"

Prophylactic therapy is a preventive medical treatment given to stop a disease or condition before it occurs, such as a vaccine, preventative drug, or surgical measure that lowers the chance of illness. Investors watch these therapies because they can create large, steady markets, alter long‑term healthcare costs, and affect regulatory approval and insurance coverage; like a safety net, they change future demand and risk profiles for companies making the products.

cgmp technical

"process development, regulatory submission and cGMP manufacture"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

continuous bioprocessing technical

"utilizing its continuous bioprocessing platform"

A manufacturing approach for biological drugs and vaccines where cells, fluids and purification steps run continuously instead of in separate, time-limited batches. Like an assembly line that never stops, continuous bioprocessing moves material through cell growth and downstream purification in a steady flow to maintain consistent product quality, reduce idle time and often shrink facility size. It matters to investors because it can change production costs, speed scale-up and affect supply reliability and regulatory oversight.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• First-in-human Phase 1 study initiated for investigational antibodies targeting orthopoxviruses developed under U.S. Department of War Accelerated Antibodies Program
• Supports development of countermeasures against orthopoxviruses, a high-priority biological threat family that includes viruses responsible for smallpox
• Delivers integrated process development, regulatory submission and manufacturing of clinical trial material at J.POD® Redmond facility
• Demonstrates scalable model for development and continuous manufacturing for biodefense preparedness

SEATTLE and HAMBURG, Germany, Sept. 9, 2026 /PRNewswire/ -- Evotec SE (NASDAQ: EVO) (Frankfurt Prime Standard: EVT) today 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 U.S. Department of War's Accelerated Antibodies Program.

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, utilizing its continuous bioprocessing platform.

This milestone delivers on the scope of Just – Evotec Biologics' 2023 contract with the U.S. 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 optimization 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 U.S. 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 U.S. Department of War's Accelerated Antibodies Program, following an initial 2022 program 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 U.S. 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. Reference to the Department of War, CPE-CBRND, or other agency of the United States does not constitute or imply an endorsement or recommendation by the United States Government or any agency thereof.

Additional information regarding the study is available on ClinicalTrials.gov (NCT07595458).

About Just – Evotec Biologics, Inc.

Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.

About Evotec SE

Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision. Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling. With flexible partnering models tailored to our customers' needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility. Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability. With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology. Evotec's global team of around 4,500 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements

This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec's securities. Words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "should," "target," "would" and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec's expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Investor Relations and Media Contact
Dr. Sarah Fakih
EVP Head of Global Communications & Investor Relations
Sarah.Fakih@evotec.com 

 

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SOURCE Evotec SE

FAQ

What is JST-018 and what does it target?

JST-018 is a cocktail of investigational monoclonal antibodies developed by Just – Evotec Biologics that targets orthopoxviruses, a virus family that includes the variola virus, which causes smallpox, as well as the virus responsible for mpox.

What is the intended use of JST-018 in this program?

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 from orthopoxviruses.

Which development and manufacturing activities were completed before starting the Phase 1 trial?

Just – Evotec Biologics completed antibody sequence selection, preclinical development, process development, regulatory submission and cGMP manufacture of clinical trial material, using its continuous bioprocessing platform at the J.POD® facility in Redmond, Washington.

How large is Just – Evotec Biologics' funding potential under the U.S. Department of War Accelerated Antibodies Program?

The orthopoxvirus program is the second award under the Accelerated Antibodies Program, following a 2022 contract for plague antibodies. The company states that the two contracts together have a combined potential value of up to $123.9 million.

Who awarded the orthopoxvirus contract and under what framework?

The orthopoxvirus contract was awarded in 2023 by the U.S. Department of War's Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND), in collaboration with BARDA, through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority, under contract number MCDC2203-001.

Where can more information about the JST-018 Phase 1 study be found?

Additional information on the JST-018 Phase 1 clinical study is available on ClinicalTrials.gov under identifier NCT07595458.