NewLink Genetics Fast-Tracks Ebola Vaccine To Human Trials

In an exclusive Reuters report, NewLink Genetics announced they were ready to launch human safety trials of an Ebola vaccine developed by Canadian government scientists later this summer.

While Dr. Charles Link, chief executive of NewLink, stated that the company already had sufficient supplies set aside during the animal clinical trials to begin testing on humans immediately, NewLink has already secured two contract manufacturing companies with the possibility of a third. With the assistance of these companies, NewLink will be able to exponentially increase their supply of the vaccine within a few months.

The most likely participants of these trials are U.S. Military personnel and those doctors on the front-lines of the Ebola outbreak in West Africa.  However, Link also specified that at least one of the trials will take place on U.S. soil.

The WHO emergency summit, which met earlier this month, greenlit many experimental interventions — even those in early stages of development. The scale of the outbreak and the hopelessness of Ebola’s prognosis, according to the WHO, outweighed the risk involved, and WHO unanimously decided that clinical trials could proceed as long as scientists followed ethical criteria laid out by the organization.

This left the developers of these experimental treatments scrambling for sufficient supplies to proceed with their research.

Dr. Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown, told CNN, “There are not adequate supplies of any of the investigational agents anywhere near ready for human use.”

According to Reuters, NewLink’s surge forward in the race is due, in large part, to an allocation of funds ($1M) from the United States Defense Threat Reduction Agency (DTRA) which was given to BioProtection Systems, a wholly owned subsidiary of NewLink.

BioProtection Systems will use the million dollars to fund pre-clinical toxicology studies and step up manufacturing. This investment will reduce the time-frame of the process from 8-10 months to “a matter of weeks.”

Link said in a press release that "This Ebola vaccine has been 100 percent effective in preventing lethal infection when given to non-human primates before they are infected with the virus. The vaccine also acts rapidly enough to have significant efficacy even when given to animals that have recently received a typically lethal dose of Ebola virus."

Reuters reports that research for experimental treatments created by Tekmira Pharma and Mapp Biopharmaceuticals have also scaled up. Tekmira’s interventional treatment is the only one so far to advance to full-scale human clinical studies.