Without convincing data to prove a win for NewLink Genetics' late-stage cancer vaccine, it will go full steam ahead on its Phase III trial, the company announced Monday. The IMPRESS trial for algenpantucel-L--or HyperAcute pancreas--will continue with no changes following the second planned interim analysis for the trial.
NewLink Genetics rattled investors after the markets closed on Monday, saying it will need to cruise past its second planned interim analysis for a late-stage cancer vaccine without any change to the trial. No news is bad news as far as the market is concerned.
GlaxoSmithKline's Ebola candidate will be the first of several experimental vaccines to undergo large-scale clinical trials. On Friday, the company shipped an initial batch of 300 vials of the vaccine, ChAd3, to Liberia, one of the main countries affected by Ebola.
The previously suspended Swiss trial of Merck and NewLink's experimental Ebola vaccine is back on, but this time at a lower dose.
NewLink Genetics and its new partner Merck have gotten a $30 million grant from the U.S. government to help with manufacturing and development of the Ebola vaccine the two are working on.
Investigators have suspended a Phase I study of NewLink Genetics' Ebola virus vaccine just weeks after Merck stepped in to license it, citing a safety issue that could delay the pharma giant's plans to quickly ramp up production.
Just days after GlaxoSmithKline and the NIH's National Instite of Allergy and Infectious Diseases announced Phase I success for their investigative Ebola vaccine, Merck and NewLink Genetics have their own positive news to report.
Merck has snapped up the exclusive rights to NewLink Genetics' Ebola vaccine, which is being rushed into a Phase III study as part of a global effort to head off an outbreak in West Africa.
To scale up production of its Ebola vaccine, NewLink Genetics is going to need some manufacturing help. And for that, it's turning to vaccine giant Merck.
In Canada, which has no reported cases of Ebola, people are lining up to get in on a clinical trial for an Ebola vaccine.