FDA rushes J&J, NewLink Genetics Ebola vaccines to clinical trials

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Ebola virus under an electron microscope--Courtesy of CDC

Another Big Pharma player is joining the hustle toward an Ebola vaccine as the death toll surpasses 1,900 victims, eclipsing the total number of people who died from the disease in all previous outbreaks combined.

Johnson & Johnson ($JNJ) on Thursday announced that the FDA would fast-track the development of an investigational combination vaccine it's developing alongside partner Bavarian Nordic with the help of the National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health. With the FDA blessing, J&J hopes to test the jab in clinical trials in early 2015.

The vaccine regimen combines elements of two different technologies from each company--the MVA-BN platform from Danish Bavarian Nordic and AdVac from J&J's vaccine arm Crucell, based in the Netherlands--for a prime-boost vaccine that uses one vector to prime and another to boost immune response.

The monovalent vaccine is designed to protect against the Zaire strain of the Ebola virus, which is responsible for the current outbreak in West Africa and is the most dangerous of the four known Ebola-causing viruses. The experimental monovalent vaccine is part of a bigger, ongoing effort at Crucell and Bavarian Nordic to eventually develop a multivalent vaccine against all deadly filoviruses that affect humans, including Ebola and Marburg viruses.

At the same time, Johnson & Johnson is also investigating previously tested drugs that may be able to help patients survive an Ebola infection.

Meanwhile, the FDA also gave the green light to Iowa-based NewLink Genetics ($NLNK) to go ahead with Phase 1 clinical trials with its Ebola vaccine candidate, originally developed by the Public Health Agency of Canada.

NewLink's vaccine targets a protein the makes up the outer layer of the Ebola virus and has been shown to induce antibodies that neutralize the virus. The trial--conducted in partnership with the U.S. Department of Defense's Defense Threat Reduction Agency and the Walter Reed Army Institute of Research--will enroll 40 healthy volunteers to test the safety of the vaccine as well measure whether volunteers develop the same levels of antibody response shown in monkeys that were protected against the virus in preclinical studies.

NewLink also plans to launch trial sites in Europe and Africa and has recently signed agreement with manufacturers to ramp up vaccine production.

The Ebola outbreak shows no signs of slowing down anytime soon, and on Wednesday the World Health Organization estimated that $600 million is needed to control the epidemic, which has claimed about 55% of those infected.

- get more from FierceBiotech
- read the Johnson & Johnson statement
- see NewLink Genetics' news

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