Anthrax Clinical Trials Analysis 2025: Next-Generation Vaccines, Monoclonal Antibodies, and Antitoxin Therapies Enhance Biodefense Preparedness | DelveInsight

DelveInsight's "Anthrax - Clinical Trials Analysis, 2025" reviews an evolving pipeline designed to strengthen protection against Bacillus anthracis infection and biothreat exposure. While antibiotics remain the cornerstone of anthrax management, limitations in post-exposure efficacy and resistance concerns drive the need for innovative interventions.

Current trials are advancing next-generation recombinant vaccines offering rapid and durable immunity, alongside monoclonal antibody therapies targeting protective antigens for both prophylaxis and treatment. Antitoxin candidates and immune-enhancing approaches are also under evaluation to improve survival in systemic and inhalational anthrax cases.

With government-backed funding and biodefense initiatives accelerating progress, late-stage vaccine and antibody programs are poised to set new standards in anthrax preparedness and response.

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Key Takeaways from the Anthrax Pipeline Report
• DelveInsight's anthrax pipeline analysis depicts a strong space with 10+ active players working to develop 10+ pipeline drugs for anthrax treatment.
• The leading anthrax companies include GC Pharma, Emergent BioSolutions, BlueWillow Biologics, Paratek Pharmaceuticals, Altimmune, Greffex, Planet Biotechnology, Integrated BioTherapeutics, DEINOVE, Hawaii Biotech, VLP Biotech, Aphios Corporation, Enesi, and others are evaluating their lead assets to improve the anthrax treatment landscape.
• Key anthrax pipeline therapies in various stages of development include GC1109, AV7909, BW 1010, Omadacycline, rPA 102, NasoShield, Research programme: DNA vaccines, PBI 220, Ba ISTAb, DNV3837, and others.
• In April 2025, Elusys Therapeutics praised the introduction of H.R. 2707 - the Protecting American Families and Servicemembers from Anthrax Act - and called for its swift approval to strengthen national biodefense efforts.
• In July 2023, Emergent BioSolutions received FDA approval for CYFENDUSTM (formerly AV7909), an adjuvanted anthrax vaccine for post-exposure prophylaxis in adults aged 18-65, used alongside antibiotics. Approval was based on efficacy data from animal studies.

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Anthrax Overview
Anthrax is a rare but serious infectious disease caused by Bacillus anthracis, a gram-positive, spore-forming bacterium found naturally in soil. It primarily affects domestic and wild animals, but humans can become infected through direct or indirect contact with contaminated animals or animal products. While uncommon in regions like the United States, anthrax poses a significant public health threat due to its potential for severe illness and use as a biological weapon. The disease manifests in various forms-including cutaneous, inhalation, gastrointestinal, and injection anthrax-each with varying degrees of severity and risk.

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Anthrax Treatment Analysis: Drug Profile
GC1109: GC Pharma
GC1109 is a vaccine targeting the anthrax toxin, which acts as a receptor-binding antigen during infection. It is produced by culturing and purifying genetically engineered Bacillus brevis. In Phase I and II clinical trials, GC1109 demonstrated a strong safety profile and dose-dependent immunogenicity. The vaccine is currently in Phase II development.

AV7909: Emergent BioSolutions
AV7909 is being developed as a post-exposure prophylactic vaccine for Bacillus anthracis infection, to be used alongside standard antimicrobial therapy. It consists of Anthrax Vaccine Adsorbed (AVA) combined with an adjuvant to enhance immune response. The vaccine is currently in Phase III of clinical development.

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Anthrax Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Parenteral
• Intravitreal
• Subretinal
• Topical

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Anthrax Pipeline Report
• Coverage: Global
• Key Anthrax Companies: GC Pharma, Emergent BioSolutions, BlueWillow Biologics, Paratek Pharmaceuticals, Altimmune, Greffex, Planet Biotechnology, Integrated BioTherapeutics, DEINOVE, Hawaii Biotech, VLP Biotech, Aphios Corporation, Enesi, and others.
• Key Anthrax Pipeline Therapies: GC1109, AV7909, BW 1010, Omadacycline, rPA 102, NasoShield, Research programme: DNA vaccines, PBI 220, Ba ISTAb, DNV3837, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Anthrax Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Anthrax Pipeline Therapeutics
6. Anthrax Pipeline: Late-Stage Products (Phase III)
7. Anthrax Pipeline: Mid-Stage Products (Phase II)
8. Anthrax Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

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