NewLink Genetics Corporation announced on Sept. 4, 2014 that FDA approved the continuance to Phase 1 clinical trials with the company’s Ebola vaccine candidate. The vaccine was developed by the Public Health Agency of Canada (PHAC) and is under an exclusive licensing arrangement with BioProtection Systems, a wholly-owned subsidiary of NewLink Genetics. This vaccine had positive results in both pre- and post-exposure vaccination of non-human primates exposed to lethal doses of the Ebola virus. NewLink Genetics is working with the US Department of Defense's Defense Threat Reduction Agency (DTRA) and the Walter Reed Army Institute of Research (WRAIR) to launch the initial Phase 1 safety trial.

The vaccine is directed at the protein, which forms the outer coat of the Ebola virus and has been shown to induce antibodies that neutralize the virus. Approximately 40 healthy volunteers will be immunized and then followed to determine the safety of the vaccine and the magnitude and durability of any immune response, including whether these volunteers develop the same levels of antibody responses that are thought to protect monkeys in Ebola challenge studies.

NewLink anticipates additional Phase 1 studies will be undertaken to examine different dosing schedules and extension to vulnerable populations. These studies are planned with other collaborators such as National Institute of Allergy and Infectious Disease (NIAID), PHAC, and the World Health Organization.

FDA gives NewLink Genetics approval to proceed to Phase 1 clinical studies of Ebola vaccine.