The image shows a liver cell infected with 10200 strain of Crimean-Congo hemorrhagic fever virus (CCHFV). The red colored structures are the CCHF virions.
News — A new transatlantic collaboration between the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and LifeArc will look to develop an affordable and accessible monoclonal antibody therapeutic for Crimean-Congo Hemorrhagic Fever Virus (CCHFV), which could treat and protect thousands of people globally.
Affordable antibody treatments
Dr. Aura Garrison, Dr. Joseph Golden and their colleagues from USAMRIID discovered the antibody in mice during a study first published in 2019 in Science Advances. With LifeArc’s funding and scientific support, they now hope to produce a fully humanized antibody therapeutic ready for Investigative New Drug submission to the U.S. Food and Drug Administration and Phase I clinical trials.
Monoclonal antibodies (mAbs) are among the most effective treatments in modern medicine, but they are also some of the most expensive and are under-utilised for infectious disease. Around 80% are sold in the US, Canada and Europe, with limited access to mAb treatments in many low- and middle-income countries (LMICs). The collaboration between LifeArc and USAMRIID is a step towards enabling global access to treatments for both civilians and military populations in high-risk areas, with a specific focus on those in LMICs.
CCHFV is endemic in Africa, the Balkans, the Middle East, and Asia. The U.S. Centers for Disease Control and Prevention estimate that 10,000-15,000 cases occur every year with high mortality rate (up to 40%). CCHFV tick-vector is also spreading into new geographical locations, including western Europe. During seasonal outbreaks, medical professionals are especially vulnerable to infection from patients. From a biodefense perspective, the U.S. military is interested in protection against CCHFV of personnel stationed in high-risk areas. Currently, there are no approved therapeutic or prophylactic treatments available. CCHFV is designated as a biosafety level 4 (BSL4) pathogen, requiring the highest level of containment and safety measures. It is also considered a Category A bioterrorism/biological warfare agent, which further hurdles research and development efforts. From a Global Health perspective, LifeArc is interested in accelerating affordable, innovative products for infectious disease that address LMIC priority unmet needs.
Building on LifeArc’s successful track record in antibody humanisation, including the development of one of the world’s most successful cancer drugs, pembrolizumab, and the Alzheimer’s drug lecanemab, the LifeArc research team will engineer USAMRIID’s mAb and screen hundreds of humanized variants against different CCHFV strains to identify the most promising mAb. While LifeArc will lead pre-clinical drug metabolism and pharmacokinetic studies to determine the mAb pharmacological characteristics and properties, USMARIID will leverage their expertise and BSL4 capabilities to test the lead mAb efficacy in a CCHFV infection model in mice. The project will also fund USAMRIID for the development of a biological marker, essential for clinical testing.
With LifeArc financial support (over $2 million), USAMRIID will lead CMC development of the novel CCHFV therapeutic mAb, however the project will also support a clinical development roadmap for accessible mAb therapies. This will include early engagement with the World Health Organization, regulatory agencies and endemic countries to establish a Target Product Profile that ensures suitability for use in LMICs.
“This project has the potential to improve thousands of lives. By funding the development of monoclonal antibody therapeutics and implementing measures to make sure they are accessible in endemic regions, we are contributing to a more equitable global healthcare system. Our mission is not only to advance medical research but also to ensure that new treatments are accessible to those who need them most, regardless of location or wealth.”
Ghada Zoubiane, Head of Global Health, LifeArc
Dr. Golden explains: “An antibody product capable of affording both therapeutic and prophylactic protection against CCHFV would be a net benefit for world health, as it would limit disease severity in infected individuals, but also protect medical care providers from becoming infected.”
“It is exciting to be part of this research,” says Dr. Garrison. “USAMRIID has been working with CCHFV for decades, and we finally have the tools needed to develop human products capable of mitigating this disease. Protective antibodies against viruses are often able to neutralize the virus; however, neutralizing antibodies do not play a key role in protection against CCHFV. In fact, it was surprising that GP38, which is not a target of neutralizing antibodies, turned out to be a critical protein for protective antibodies.”
USAMRIID’s extensive CCHFV research has focused on understanding how the virus causes disease, developing preventive vaccines, and creating therapeutics that prevent and treat viral infection. The Virology Division supports discovery of both specific and broad-spectrum medical countermeasures against viral threats. Research areas include molecular virology, cell biology, immunology, viral virulence factor determination, and viral strain diversity characterization. It also supports FDA licensure requirements by studying the natural history of disease and pathogenesis.
About the U.S. Army Medical Research Institute of Infectious Diseases:
Since 1969, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to vaccines, drugs, diagnostics, and training programs that protect both Warfighters and civilians. The Institute's unique science and technology base serves not only to address current threats to our Armed Forces but is an essential element in the medical response to any future biological threats that may confront our nation. For more information, visit .
About LifeArc:
LifeArc is a not-for-profit medical research organisation. We turn promising scientific research into impact for people living with rare diseases and global infectious diseases.
We form partnerships and provide scientific expertise and funding to help break down the barriers preventing scientific breakthroughs from becoming life-transforming treatments and cures. We have been doing this for more than 30 years and our work has resulted in five licensed medicines, including cancer drug pembrolizumab (Keytruda®) and lecanemab for Alzheimer’s (Leqembi®).
Our goal is a world where no one with a rare disease or global infectious diseases misses out on life-changing innovation because of complexity, cost or risk.
LifeArc is a company limited by guarantee (registered in England and Wales under no. 2698321) and a charity (registered in England and Wales under no. 1015243 and in Scotland under no. SC037861).
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