May 12, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Ames, Iowa-based NewLink Genetics is having a rough Tuesday, falling more than 20 percent in early trading on news that more than 75 percent of the patients involved in its Phase III pancreatic experimental therapeutic vaccine trial have died.
That news has dashed hopes that the drug could show any statistical efficacy and forced Wall Street into a broad selloff of the company, which had earlier seen a booming fall 2014 after repeated success with an Ebola vaccine.
The Phase III IMmunotherapy for Pancreatic RESectable cancer Study, named “IMPRESS,” studied the effects of algenpantucel-L on patients with surgically resected pancreatic cancer following the second planned interim data analysis. The vaccine, dubbed Hyper Acute, was used in a trial that had 722 patients involved, with half given the drug and the other half non-dosed.
The news that three-quarters of the patients enrolled had already died, in line with expected survival curves was a double whammy for New Link—especially since algenpantucel-L had already received fast-track status and orphan drug designation from the U.S. Food and Drug Administration (FDA).
Despite the results, the company said it would continue testing the drug and working with regulators to bring it to what it feels is a much-needed market population.
“Our fast-track status, orphan drug designation and SPA give us continued confidence in our regulatory strategy. With this in mind, we are thoughtfully preparing for regulatory filings and commercial activities associated with a potentially positive outcome of the trial,” said Charles Link, New Link’s chairman and chief executive officer. “There has been tremendous progress in oncology therapeutics, but there have been only incremental improvements in overall survival rates for pancreatic cancer. Our goal is that the result of the IMPRESS study will contribute to the advancement of immunotherapy as a new treatment option.”
New Link had better success in late December, when it said its second vaccine for Ebola has shown encouraging results in protecting volunteers without producing serious side effects, said Swiss researchers who had tested the tandem Merck & Co. drug.
The shot, developed by Merck and NewLink, produced only a mild fever in some of the 34 volunteers fast-tracked to test the drug at the University of Geneva in a clinical trial earlier this fall. Dubbed VSV-ZEBOV Ebola vaccine, the World Health Organization (WHO), had been overseeing the drug’s progress.
“After his or her injection, each volunteer was kept under observation for 1.5 hours at the clinical trials unit,” said scientists. “To date, no major side effects have been observed after the injections, which triggered the expected inflammatory responses. They (the inflammatory responses) have been weak to moderate, with limited cases of mild fever.”
Merck and NewLink said that trials on the drug have already started in the U.S., Canada, Germany and Gabon. Merck announced in November 2015 that it would buy the rights to NewLink‘s vaccine for $50 million. Merck bought the rights to NewLink‘s vaccine for $50 million in November.
That news followed an announcement that GlaxoSmithKline and the National Institutes of Health (NIH) have seen promising results from an Ebola vaccine candidate and will speed the new drug into the next phase of clinical trials.
The results for the monovalent vaccine were published in the New England Journal of Medicine and the agency has said that it now hopes to begin testing the vaccine on healthcare workers and other groups at high risk for infection.
Drugmakers and regulators worldwide had been rushing to find a vaccine or cure for Ebola as the epidemic continued.
The monovalent vaccine was tested on 20 American volunteers this fall and all 20 developed antibodies against Ebola, with no side effects, said the clinical paper. The volunteers ranged in age from 18 to 50 and were split into two groups, with half receiving an intramuscular injection of vaccine at a lower dose, and 10 receiving the vaccine at a higher dosage level. All 20 then developed antibodies within four weeks of receiving the vaccine, and those given the higher-dose vaccine had more antibodies.
