CEPI Recognizes USU-Developed mAb Against Nipah Virus as a Top Innovation for Force Health Protection
The USU-developed monoclonal antibody 1F5 (MBP1F5) has been recognized by the Coalition for Epidemic Preparedness Innovations (CEPI) as a top innovation for 2024 due to its potential to protect against the deadly Nipah virus, driving forward clinical trials.
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The Coalition for Epidemic Preparedness Innovations (CEPI) has recognized the monoclonal antibody 1F5 (MBP1F5), which USU developed, as a top innovation for 2024, due to its potential to protect against the deadly Nipah virus. (Image credit: Melissa Martin, USU. Photo by National Institute of Allergy and Infectious Diseases, Nipah Virus cell image credit NIAID) |
April 24, 2025 by Hadiyah Brendel
Health security faces ongoing challenges from infectious diseases, requiring innovative solutions and collaboration. The Nipah virus, transmitted by flying foxes (fruit bats), is a persistent threat, capable of causing severe illness with a fatality rate as high as 90 percent. Given repeated outbreaks and the potential for rapid spread, effective countermeasures are essential. Pioneering research at the Uniformed Services University (USU) on the monoclonal antibody (mAb) 1F5 (MBP1F5) offers a promising solution to this global challenge.
USU’s Pioneering Research Gains International Recognition
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Like Nipah, the Hendra virus was also discovered in the 1990s and has also been found naturally in several species of fruit bats. (Courtesy photo) |
The Threat of Nipah Virus
Both Nipah virus and Hendra virus are naturally found in Pteropid fruit bats (flying foxes). Transmission to humans spreads via contaminated raw date palm sap or direct exposure to other animals infected by the viruses. Person-to-person transmission of Nipah virus is also possible. Virus infection is characterized by an acute respiratory distress syndrome and encephalitis (swelling of the brain). Once contracted, the virus can have a staggering human fatality rate. Compounding the severity of these outbreaks is the absence of any licensed vaccine or specific treatments, making the development of an effective countermeasure a critical priority.
Unveiling the 1F5 Monoclonal Antibody
Broder's work on developing the MBP1F5 mAb therapy began about 15 years ago. Earlier research by the Broder lab and colleagues on mAb countermeasures to Nipah and Hendra viruses led to the discovery of mAb m102.4, which recognizes the G glycoprotein spike of the viruses. Since 2010, the m102.4 mAb has been given to 18 patients worldwide on an emergency-use basis following significant risk of Hendra or Nipah virus infection. The donation of m102.4 to Australia as a countermeasure against Hendra virus infection resulted in the 2019 Federal Laboratory Consortium Award for Excellence in Technology Transfer.
Researchers created the new 1F5 mAb in 2011, which also reacts to both the Nipah and Hendra viruses. Testing has shown 1F5 is more effective than m102.4. A key difference is 1F5’s specificity to the F, or fusion, glycoproteins of both Nipah and Hendra viruses, effectively neutralizing the viruses and preventing infection. Preclinical studies demonstrated 1F5’s 100% success rate in providing protection, even when administered five days post-infection.
Broder expresses reserved enthusiasm, stating, “The remarkable success of this new MBP1F5 mAb therapy against both Nipah virus-Bangladesh and Hendra virus infection…is a key step towards its further clinical development as an effective therapeutic for use in people.”
Advancing to Clinical Trials
The U.S. DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense has awarded Mapp Biopharmaceuticals, Inc. funding to complete a Phase I trial to assess the safety of 1F5. Following the trial's completion, CEPI has committed $43 million to provide support to ServareGMP and Mapp Bio to conduct further clinical safety testing and advance its development.
The DoD-sponsored trial in the U.S. will specifically develop the mAb for its potential to protect service members during suspected exposure to Nipah virus outbreaks. The goal is to develop an easily administered intramuscular injection with a long half-life, providing soldiers with immediate protection that will last at least six months.
Recognizing the health threat posed by Nipah virus, CEPI is planning to fund additional Phase 1 safety trials in India and Bangladesh, where Nipah virus outbreaks occur frequently, at a rate about once every two to three years. Broder says the plan is to have the antibody available on hand in Bangladesh and India to administer immediately to patients when needed.
The Significance of CEPI Recognition
CEPI's recognition of MBP1F5 as a top innovation for 2024 is rooted in its demonstrated protection against the Nipah virus, and its strong potential as an effective human therapeutic. This acknowledgement underscores Broder’s work and USU’s vital contributions not only to military medicine, but also to developing solutions for worldwide health challenges.
