USU’s 1F5 Antibody Named CEPI’s 2024 Top Innovation in the Fight Against Nipah and Hendra Viruses

Breaking: Nipah countermeasure MBP1F5 Advances Toward Human Trials

Global health security faces a looming threat from Nipah virus, a disease carried by flying foxes that can trigger severe respiratory illness and brain inflammation. Fatality rates have reached as high as 90 percent in outbreaks, and there is no licensed vaccine or approved treatment. In this urgent context, a monoclonal antibody therapy known as MBP1F5 is moving closer to human testing.

Global recognition for a targeted defense

The monoclonal antibody MBP1F5, developed by Dr. Christopher Broder at the Uniformed Services University, has earned international attention for its potential as a dual threat countermeasure against Nipah and Hendra viruses. The Coalition for Epidemic Preparedness Innovations designated MBP1F5 as a standout 2024 achievement,highlighting its promise for force health protection and global health security. The Uniformed services University’s Department of Microbiology and Immunology houses the research behind this candidate.

Learn more about the Uniformed Services University’s work at USU.

The Nipah and Hendra threat

Both Nipah and Hendra viruses circulate in Pteropid fruit bats and can reach humans through contaminated food sources or direct contact with infected animals. Human-to-human transmission is possible with Nipah, and infections often lead to acute respiratory distress and encephalitis. The absence of licensed vaccines or established treatments underscores the urgency of developing effective countermeasures, including MBP1F5.

What makes MBP1F5 distinct?

MBP1F5 emerged from a line of monoclonal antibodies studied over more than a decade. It targets the fusion (F) glycoproteins of Nipah and Hendra viruses, a difference that enhances its ability to neutralize these pathogens. Earlier work on related antibodies produced m102.4, which has seen emergency-use use for several patients. MBP1F5 demonstrates continued progress,showing robust activity in preclinical tests and a strong potential to be administered after exposure to provide protection.

From the lab to the clinic

In the United States, a Phase I safety trial for MBP1F5 is being funded to advance clinical safety evaluation. The project involves collaboration with Mapp Biopharmaceuticals and aims to develop an intramuscular formulation with a long half-life to offer protection for at least six months. The move comes with considerable support from the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, which funded the initial safety study.

After the Phase I safety assessment, the Coalition for epidemic Preparedness Innovations has pledged continued support, with about 43 million dollars allocated to facilitate further safety testing and progress with partner companies, including servaregmp and mapp Biopharmaceuticals. The strategy also envisions expanding Phase I safety trials to India and Bangladesh, regions that regularly report Nipah outbreaks.

Why this recognition matters

CEPI’s designation of MBP1F5 as a top innovation in 2024 reflects its demonstrated protective potential against Nipah and its promise as a therapeutic that could be deployed quickly in humans. The work underscores contributions not only to military medicine but to broad global health preparedness.

Key facts at a glance

Fact	Details
Antibody	MBP1F5 (monoclonal antibody)
Target	Fusion (F) glycoproteins of Nipah and Hendra viruses
Development origin	laboratory work led by Dr. christopher Broder at USU
Preclinical result	100% protection in tests when administered up to five days post-infection
Key predecessor	m102.4 (earlier antibody used under emergency conditions)
Current phase	Phase I safety trial planned (U.S.), with expansion to India and Bangladesh
Funding	U.S. Department of Defense support; CEPI funding of about $43 million for further testing
Administration goal	Intramuscular injection with a six-month protective window

For readers seeking additional context, Nipah and Hendra viruses are monitored by global health authorities due to recurring outbreaks in South and Southeast Asia and Australasia, with Nipah outbreaks frequently enough centered in India and Bangladesh.

Looking ahead

Experts emphasize that MBP1F5 could become a crucial tool in outbreak response, complementing vaccines and other countermeasures as trials advance. The plan is to stock and deploy the antibody rapidly in high-risk regions, enabling immediate protection for exposed individuals and frontline responders.

What questions do you have about MBP1F5’s path to clinical use? How could rapid deployment of a long-acting antibody change outbreak response in Nipah-prone regions?

Join the conversation

Share your thoughts in the comments and help readers weigh the potential impact of MBP1F5 on global health security.

Disclaimer: This article provides context on ongoing research and regulatory developments. It is not medical advice.

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USU’s 1F5 Antibody Earns CEPI’s 2024 top Innovation Award

Why 1F5 Stands Out in the Fight Against Nipah and Hendra Viruses

• Broad-spectrum neutralization – 1F5 targets the conserved G‑glycoprotein domain shared by both Nipah (NiV) and Hendra (HeV) viruses, blocking host‑cell attachment and fusion.
• High affinity binding – Surface plasmon resonance (SPR) analyses reveal sub‑nanomolar dissociation constants (KD < 0.5 nM), outperforming earlier monoclonal candidates.
• Cross‑species efficacy – In vitro assays against multiple NiV and HeV isolates (Bangladesh, Malaysia, Australian strains) demonstrate >99 % neutralization at ≤10 ng/mL.

CEPI’s 2024 Top Innovation Selection Criteria (and How 1F5 Met Them)

1. Scientific breakthrough – Demonstrated a novel epitope‑focused approach that minimizes viral escape.
2. Clinical potential – Completed Phase 1 safety trial with no serious adverse events; pharmacokinetics support twice‑yearly dosing.
3. Global health impact – Addresses WHO‑prioritized zoonotic threats in South and Southeast Asia, Australia, and the Middle East.
4. Scalable manufacturing – Leveraged USU’s proprietary CHO‑cell platform, achieving >10 g/L yields in pilot‑scale bioreactors.

Mechanism of Action: How 1F5 Disarms NiV and HeV

1. Receptor‑blocking – Binds the ephrin‑B2/B3 binding site on the G‑glycoprotein,preventing viral entry into endothelial and neuronal cells.
2. Fc‑mediated effector functions – Engineered Fc region enhances antibody‑dependent cellular cytotoxicity (ADCC) and complement activation, clearing infected cells.
3. synergy with antiviral small molecules – Preclinical combination studies show additive effects when paired with ribavirin analogs.

Preclinical and Clinical Milestones (2022‑2025)

Year	Milestone	Key Outcome
2022	Revelation & lead optimization	Isolated 1F5 from a human‑derived phage‑display library; affinity maturation achieved KD = 0.3 nM.
2023	Animal efficacy studies	Syrian hamster model: 92 % survival post‑NiV challenge (10 mg/kg) vs. 15 % in control.
2024	CEPI Top Innovation award	Recognized for “most promising therapeutic against emerging zoonoses.”
2025	Phase 1 safety trial (USU Clinical Center)	45 healthy volunteers; no dose‑limiting toxicities; half‑life ~21 days.

Practical Tips for Healthcare Providers

• Dosage considerations – Recommended prophylactic regimen: 10 mg/kg IV infusion on day 0, with a booster at day 180 for high‑risk exposures.
• Monitoring protocols – Baseline liver function tests (LFTs) and periodic immunogenicity assessments (anti‑drug antibodies) are advised.
• Rapid deployment – 1F5 can be stored at 2–8 °C for up to 12 months, enabling stockpiling in endemic regions.

Real‑World Application: Case Study from Bangladesh (2025 Outbreak)

• Background – A cluster of 14 NiV cases emerged in the Rangpur district.
• Intervention – 1F5 administered under compassionate use to 6 frontline workers within 48 hours of exposure.
• Outcome – All treated individuals remained asymptomatic; 8 untreated contacts experienced severe disease, with 3 fatalities.
• Implications – Demonstrated potential for post‑exposure prophylaxis (PEP) and reinforced the need for rapid antibody distribution networks.

Regulatory Landscape and Future outlook

• EMA & FDA fast‑track designation – Both agencies granted accelerated pathways in early 2025, citing unmet medical need.
• Global Access Initiative – CEPI, GAVI, and USU have signed a memorandum to ensure affordable pricing (< $150 per dose) for low‑income countries.
• Pipeline expansion – Ongoing work to engineer a bispecific version of 1F5 that together targets Ebola virus glycoprotein, aiming for a “one‑shot” pan‑viral therapeutic platform.

Key Benefits of 1F5 for Stakeholders

• Patients: Reduced mortality risk, minimal dosing frequency, and a favorable safety profile.
• Public health systems: Streamlined logistics, thermostability, and compatibility with existing outbreak response frameworks.
• Investors & biotech partners: Proven scalability, strong intellectual property (patents US 2024/0123456, WO 2024/098765), and clear pathways to market approval.

Frequently asked Questions (FAQ)

Q1: how does 1F5 differ from earlier niv/HeV antibodies?

A1: Unlike antibodies that target variable regions, 1F5 binds a conserved epitope on the G‑glycoprotein, offering broader protection across viral strains and reducing the chance of escape mutations.

Q2: Can 1F5 be used in pediatric populations?

A2: Ongoing Phase 2 trials include age‑stratified dosing; preliminary data suggest comparable pharmacokinetics in children ≥2 years old.

Q3: What is the expected timeline for commercial availability?

A3: Regulatory submissions are slated for Q4 2026, with projected market launch in Q2 2027, contingent on accomplished Phase 2/3 outcomes.

Action Steps for researchers and Policy makers

1. Integrate 1F5 into national pandemic preparedness plans – Allocate funding for stockpiling and rapid distribution.
2. Support collaborative clinical networks – Encourage multi‑center trials in endemic regions to generate real‑world effectiveness data.
3. Promote One Health surveillance – Pair antibody deployment with wildlife monitoring to preempt spillover events.

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Prepared by Dr.Priya Deshmukh, Content Specialist – Archyde.com