On the heels of crushing Phase III results for its pancreatic cancer candidate, NewLink Genetics has won a lifeline from the U.S. government. The biotech nabbed up to $76 million in BARDA funding to advance its Merck-licensed Ebola vaccine.
Through an initial tranche, the Biomedical Advanced Research and Development Authority will provide $24.8 million to prep the manufacturing process for the vaccine and to support clinical trials needed for a regulatory nod. Another $51 million in options could be awarded down the road.
The rVSV-ZEBOV vaccine, which Merck & Co. licensed from NewLink in late 2014, won FDA and EMA milestones this summer in a push toward licensure. Merck plans to submit the vaccine for approval by the end of 2017 as part of a partnership with Gavi; through that deal, the Vaccine Alliance will pay $5 million to build a stockpile.
For Ames, IA-based NewLink, the support funds come after the biotech announced poor Phase III trial results for its pancreatic cancer vaccine algenpantucel-L, a development that gutted shares and prompted a restructuring. The biotech downsized by 100 employees and reduced manufacturing capacity and HQ space.
In the wake of the trial failure, NewLink pivoted to its Ebola vaccine, which has seen rapid advancement following the 2014 outbreak. In a Phase III ring study, the vaccine protected 100% of subjects.
That the Merck-NewLink Ebola vaccine is moving toward the finish line is likely welcome news to some disease experts, who worried that the Zika outbreak could divert attention and leave Ebola work unfinished. With the deadly Ebola outbreak waning in 2015, pharmaceutical companies with promising candidates saw their trial options narrow as it became tougher to test effectiveness.
Aside from Merck, Big Pharma player GlaxoSmithKline has pushed an Ebola vaccine candidate into Phase III. Smaller companies Novavax, Profectus Biosciences and Inovio are working in the space as well.
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