A Gaithersburg biopharmaceutical company is on the verge of proving the effectiveness of its vaccine against the Ebola virus. Gale Smith, Ph.D., Novavax’s vice president of vaccine development, announced the status of the fast-track project Oct. 26 at the Vaccine and ISV Conference in Philadelphia.
“We used the recently published Guinea 2014 Ebola strain genetic sequence to create a highly purified, correctly folded Ebola GP (glycoprotein) vaccine in only a few weeks,” said Gregory Glenn, M.D., the company’s senior vice president of research and development.
Novavax’s preclinical models have shown that its Ebola GP recombinant nanoparticle vaccine neutralizes both old and new strains of the Ebola virus in animals.
“Viruses change to evade elimination by human immune mechanisms,” said Dr. Glenn, who trained at Walter Reed Army Medical Center and has studied vaccine development for 23 years. “In 1976, Ebola in various animals was being transmitted to humans. The current strain is 100 percent limited to human to human transmission.”
Dr. Glenn maintained that changes in strain are significant, and using the currently circulating strain as the basis of the vaccine is vital. Pharmaceutical companies, like GlaxoSmithKline, he noted, are using older strains of the virus in developing their vaccines.
Most companies rely on a technology of producing vaccines that involves isolating the pathogen or virus and killing it, Dr. Glenn said. But with Novavax’s recombinant protein nanoparticle technology, the virus itself is never touched. “We look at the sequence of the genome, what the genetic material is composed of, get a blueprint, then artificially synthesize the protein,” he explained.
Novavax has demonstrated it can make effective vaccines quickly and efficiently.
“This is a global health emergency,” Dr. Glenn said, which makes an immediate response imperative. “We’ve done this before. We’re good at this.”
He cited the company’s work last year on a vaccine for the lethal avian flu (known as H7N9), which was developed and tested in less than four months after the virus was identified and sequenced. The Phase 1 clinical trial results were published in the New England Journal of Medicine in November. “They almost never do that,” Dr. Glenn said, which demonstrates “the importance of the achievement.” Novavax had used the same platform in vaccines for and Middle Eastern Respiratory Syndrome (MERS).
“We are not a small biotech or an academic institution,” Dr. Glenn said, pointing out that the company employs some 280 people and has three manufacturing facilities plus a joint venture in India. “And we’re more agile than a large biotech. Our work is quite specific.”
Novavax has initiated a non-human primate study and is moving into a Phase 1 clinical trial that will evaluate the safety of its Ebola vaccine and measure its immune responses. Proper dosage will be determined by the end of this year.
“We have a good sense that the immune response will be protective,” Dr. Glenn said. “There will be no gating steps; we don’t need to wait to see which of our models (rodent or non-human primate) works for humans – there is hot debate about this – (Instead) we will develop them all, in parallel.” Phase 1 trial data will be the basis for planning a large-scale global clinical trial in collaboration with global regulatory authorities and world health agencies.