NewLink and Merck are on a deadline, with plans to submit their Ebola vaccine for regulatory approval in 2017. Now, NewLink is getting a $26.1 million boost from the Biomedical Advanced Research and Development Authority (BARDA), bringing the company's total BARDA funding to more than $70 million.
The new funding will go toward clinical bridging studies to assess safety, immunogenicity and efficacy in populations not included in previous clinical trials, NewLink ($NLNK) said in a statement on Monday. It comes from BARDA exercising its option to continue supporting the vaccine's development. BARDA initially awarded Ames, IA-based NewLink a $30 million contract in December 2014, when the most recent Ebola epidemic was near its peak. The deal came a month after NewLink licensed the research, development, licensure and marketing of the jab to Merck ($MRK).
The candidate is the furthest along in the Ebola vaccine race and is the only one to report Phase III results, albeit from a novel trial structure. Due to the waning Ebola epidemic, the investigators had to devise a “ring” study, identifying Ebola patients’ contacts as a “ring” of people at risk for the disease. The vaccine posted 100% efficacy in interim results reported last summer.
In January, Gavi, the global vaccine alliance, signed a $5 million pact with Merck to fund the vaccine through late-stage trials, licensure and prequalification by the World Health Organization by the end of 2017. If approved, Gavi will stockpile the vaccine for use in future outbreaks. Merck has also filed an application with the WHO to allow the use of the vaccine if an outbreak occurs before it is licensed.
Despite having pulled ahead of the crowd, Merck may find that the playing field is level again. The end of the last Ebola outbreak left companies scrambling to find enough people with exposure to Ebola to prove that the vaccine protects against actual Ebola infection. And Johnson & Johnson ($JNJ) is gaining on Merck, reporting last week that its candidate prompted an immune response in 100% of participants in a Phase I trial. J&J is working on a “prime-boost” vaccine with Bavarian Nordic, while a number of other companies, including GlaxoSmithKline ($GSK), Inovio ($INO) and Maryland-based Profectus and Novavax ($NVAX), are also developing Ebola vaccines.
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Image of scanning electron micrograph shows ebolavirus budding from the surface of a Vero cell from the African green-monkey kidney epithelial cell line. Courtesy of NIAID.