BREAKTHROUGHS BLOG

September 23, 2019

Research Roundup: Scientists release sterile mosquitoes in Burkina Faso, Themis raises $44 million for phase 3 chikungunya vaccine trial, and Merck's Ebola vaccine tees up FDA date

Ansley Kahn
Senior Program Assistant
GHTC
PATH/Satvir Malhotra

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Scientists from Target Malaria, a research consortium backed by the Bill & Melinda Gates Foundation, have for the first time outside of the lab released genetically sterilized mosquitoes in Burkina Faso to combat malaria. Using a technique known as a gene drive, scientists injected male mosquito embryos with an enzyme that sterilizes them, with the goal of reducing the mosquito population over time. Target Malaria is also developing an enzyme to prevent male mosquitoes from passing on X chromosomes, which results in all male offspring, thereby reducing malaria transmission since female mosquitoes are the ones that primarily bite and transmit disease. Researchers continue to push for new approaches to combat malaria, which killed more than 400,000 people in Africa in 2017. Progress against the disease is stalling, according to the World Health Organization (WHO).

Biotech company Themis has raised US$44 million to develop its chikungunya vaccine through a phase 3 trial and move the lead candidate from its immuno-oncology research and development (R&D) program into humans. Themis filed an IPO to raise the funds last year but held off due to “adverse market conditions,” leaving the company to consider other options to fund further development. Last month, Merck invested $200 million in Themis for vaccine R&D, indicating Themis had lined up private financing to fund further development. The phase 3 trial is due to start in the coming months, enroll thousands of participants, and deliver data around the middle of next year. Themis is considering taking the vaccine to market itself.

The US Food and Drug Administration (FDA) has accepted an application for approval of Merck’s Ebola vaccine, V920, also known as rVSV∆G-ZEBOV-GP. The vaccine is eligible for priority review and Merck will learn of the FDA’s decision by March 14. If the vaccine receives FDA approval, Merck would become the first company to receive clearance to sell a vaccine against the virus in the United States. In addition to its FDA filing, Merck has had an application for approval in Europe accepted for review earlier this year and has also applied for WHO prequalification status. V920 has been used on an investigational basis during the current Ebola outbreak in the Democratic Republic of the Congo, with only 71 cases among the 93,965 at-risk people who received the vaccine, according to WHO.

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