Ongoing U.S. investment in malaria R&D opens door to more innovative tools for the malaria fight
Washington, D.C., August 12, 2021 — Malaria No More welcomes the news that a new study published today in the New England Journal of Medicine shows positive results from a first-in-human Phase 1 clinical trial of a monoclonal antibody (mAb) for preventing malaria, offering new hope for accelerating efforts against the ancient disease. The small trial was sponsored and conducted by scientists at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, where the mAb was discovered and developed.
The trial found that nine healthy adult participants who received either one or two doses of a mAb called CIS43LS were safely protected from malaria following voluntary exposure to the malaria parasite through bites of infected mosquitos in a carefully controlled setting. Notably, a single dose of CIS43LS protected two of these participants from malaria for 9 months. The newly reported findings provide the critical first proof of concept for the next phase of development already underway in Mali: a larger Phase 2 clinical trial evaluating the safety and efficacy of CIS43LS at preventing malaria infection in adults during a six-month malaria season. This trial is being led by investigators at NIAID and the University of Sciences, Techniques and Technologies of Bamako, Mali, and is being sponsored by NIAID.
Malaria No More applauds the NIH and the United States Government’s long-standing commitment to prevent, control and eliminate malaria, a disease that kills a child every two minutes. It is hoped that CIS43LS or other antibodies would become the latest tool in a long line of transformative malaria treatment and prevention modalities that were initiated with U.S. government research funding.
“Global progress against malaria over the last 20 years was driven by bold investment, led by the U.S., and relentless innovation to research, develop, and distribute life-saving tools,” said Martin Edlund, CEO, Malaria No More. While much more research is still needed, adding monoclonal antibodies to existing interventions could be transformative. “If we were able to develop a single-dose antibody that lasted six months and was easy to administer, we could disrupt transmission of malaria and provide a high degree of protection for children, pregnant women and communities during rainy seasons when malaria transmission peaks. Two doses could offer protection year-round, functioning much like a highly effective vaccine,” Edlund continued.
Monoclonal antibodies are synthetic proteins that provide immunity against infectious and non-communicable diseases. Numerous monoclonal antibody therapies are approved for use against cancers and autoimmune diseases. More recently, they have been studied as potential therapies to fight Ebola and COVID-19, with more than 70 mAb candidates currently under development.
“The potential use of monoclonal antibodies to protect against malaria is especially compelling because the antibodies take action before the malaria parasite enters the blood stream. If eventually proven effective and affordable in large, Phase 3 clinical trials, countries should move as quickly as possible to manufacture and deliver the prophylactic therapy to save hundreds of thousands of lives and reduce the enormous strain malaria cases places on health systems every year,” said Kelly Willis, Managing Director, Strategic Initiatives, Malaria No More. This therapy would also offer important new protection for U.S. military personnel deployed overseas, as well as U.S. travelers, providing longer-term protection when serving or traveling in malaria-affected countries.
The difficulty of a complex, fast-evolving malaria parasite has made development of a highly effective, long-lasting vaccine elusive to date, despite decades of research. However, in recent years, there are signs of progress with the limited release of the RTS,S vaccine – initially researched in U.S. labs – and the more recent announcement of a successful Phase 2 trial of another malaria vaccine candidate, R21/Matrix-M.
In 2019, malaria killed 409,000 people, two thirds of whom were children under 5, and there were 229 million malaria infections, according to the WHO’s 2020 World Malaria Report.
Through its significant investments in malaria-affected country programs, technical assistance and research and development of new tools, U.S. leadership has contributed to saving 7.6 million lives from malaria and preventing 1.5 billion malaria cases since 2000, putting the world on a path to ending malaria within a generation.
Anticipating their potential to save and improve millions of lives among the world’s poorest people, IAVI and Wellcome Trust recently issued “Expanding Access to Monoclonal Antibody-based Products.” The call-to-action asks global private and public global health stakeholders to “prioritize identifying pathways to expand affordable, timely, and sustainable global access to proven monoclonal antibody-based products,” especially in low- and middle-income countries.
“In responding to COVID-19, the world has shown how – with political will, funding and collaboration – we can accelerate technologies that will save millions of lives in an emergency. Malaria is an emergency every day for hundreds of millions of people around the world and we must do everything we can, as quickly as we can, to end it,” said Edlund.
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About Malaria No More
Malaria No More envisions a world where no one dies from a mosquito bite. More than a decade into our mission, our work has contributed to historic progress toward this goal. Now, we’re mobilizing the political commitment, funding, and innovation required to achieve what would be one of the greatest humanitarian accomplishments – ending malaria within our generation. For more information, visit www.malarianomore.org.