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MAM01 (Monoclonal Antibody Against Malaria)

30.10.2025

  1. MAM01 (Monoclonal Antibody Against Malaria)

Context
A new monoclonal antibody, MAM01, has demonstrated high protection against malaria in an early clinical trial led by U.S. researchers, offering a potential breakthrough for disease prevention in endemic regions.​

 

What is MAM01?

  • Nature:
    MAM01 is a laboratory-engineered monoclonal antibody (mAb) designed to neutralise the Plasmodium falciparum parasite before it enters the bloodstream, providing passive immunisation instead of provoking an active immune response.​
  • Development:
    Created by the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health (CVD).​

 

Aim and Approach

  • Objective:
    To offer immediate and months-long protection, particularly for vulnerable groups (children, pregnant women) in malaria-prone regions, without the need for multiple vaccine doses or boosters.​
  • Target:
    MAM01 blocks the parasite by binding to a conserved region of the circumsporozoite protein (CSP), an essential part in infecting liver cells.​

 

Key Features and Clinical Results

  • Single Dose & Safety:
    Phase 1, double-blind, placebo-controlled study among 38 malaria-naïve adults (18–50 years). A single dose of MAM01 resulted in 100% protection at the highest dose, with no severe adverse events detected.​
  • Dose-dependent Effect:
    Higher antibody concentrations correlated with greater protection, with serum levels above 88 µg/mL yielding full immunity in tested adults.​
  • Trial Design:
    Participants were exposed to malaria via infected mosquito bites. In the highest-dose group, none developed parasitaemia, while all placebo participants did.​
  • Well-tolerated:
    No serious adverse effects after one or two doses, confirming proof-of-concept for human safety.​

 

Significance and Way Forward

  • Transformative Potential:
    MAM01 offers a promising tool to prevent malaria, especially in sub-Saharan Africa, where over 600,000 deaths occur annually.​
  • Role in Malaria Elimination:
    It aligns with WHO’s Global Technical Strategy (GTS) 2025–2030 for malaria eradication.​
  • Future Scenarios:
    Mass immunisation, seasonal prophylaxis, and integration into targeted campaigns may be possible if production costs can be reduced.​

 

Conclusion
MAM01 marks a significant innovation in malaria prevention through long-acting, single-dose passive immunisation. Further trials and scalable manufacturing will be essential to harness its full potential in high-burden areas.​

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