A Connecticut biotechnology company hopes to be one of the frontrunners in the race to develop a vaccine to fight Ebola.
Protein Sciences, located in Meriden, is a month away from having vaccine material ready to be shipped to the National Institutes of Health, with human clinical testing in sight by the end of the year, said Manon Cox, president and CEO of the company. Although it will not be the first Ebola vaccine to reach clinical trials, it may help to fill a long-standing void in prevention for a disease with a fatality rate exceeding 50 percent.
Clinical-grade protein will be sent by Nov. 25 to the NIH, which will then carry out primate screenings, a white paper from the company stated. Monkeys will be vaccinated in December and exposed to the Ebola virus in February 2015.
In contrast to the majority of vaccines for various viruses, which contain an attenuated form of the actual virus, the vaccine in development is protein-based, meaning it is comprised of a protein found on the outer coat of the virus, instead of the virus itself. That protein has been shown to trigger antibodies — agents of the body’s defense system — in primates, said Protein Sciences executive chairman and global head of business development Daniel Adams.
“The big advantage is that ours is a simple approach,” Adams said. “We know we’re making the right protein.”
The vaccine is very similar to Flublok, which was developed by Protein Sciences to fight influenza. The only difference between Flublok and the newly developed Ebola vaccine is the use of the Ebola coat protein rather than the influenza coat protein, Adams said, adding that the protein is produced in the same way for each vaccine.
The methods used to develop Flublok have already been evaluated by the Food and Drug Administration. Since the Ebola vaccine uses the same methods, it is more feasible for the FDA to expedite the regulatory process, Cox said.
In August, in a move that reflected the urgency of the climate surrounding Ebola, the FDA announced that it would be invoking its emergency use authorization powers for approval of diagnostic tests of the virus. In September, the agency announced that it would be expanding use of experimental drugs for the virus.
With its protein base, Protein Sciences’ vaccine differs from those being developed at other pharmaceutical companies, which have focused on integrating the viral genetic material itself into the vaccine, Adams said. Cox said that relying on proteins is a safer method because it does not require having actual viruses on site for research and manufacturing and eliminates the risks associated with injecting viral DNA into a human. Currently, the efficacy of other vaccines cannot be boosted without increasing the amount of the virus, she said.
“Any regulatory agency is really tough on vaccines because they’re injected into healthy patients,” Adams said. “The NIH has told us that we have by far the safest approach.”
Protein Sciences’s current vaccine development project is a continuation of a project that began four years ago. In the original project, the company was subcontracted under an NIH grant for biodefense, targeted at preventing the weaponization of Ebola for biological warfare.
At the time, vaccines were not being developed in order to vaccinate ordinary people or health care workers, Cox said. Rather, a successfully completed vaccine would be stockpiled in case of a future act of bioterrorism. Once NIH funding was withdrawn nine months into the project, work was halted and DNA samples were frozen.
“Nobody ever realized that there would be a need for a vaccine,” Cox said.
In June, after discussions with the Biomedical Advanced Research and Development Authority, the World Health Organization and the company’s NIH project officer about the renewed need for an Ebola vaccine, Protein Sciences thawed its samples and resumed development of the vaccine despite a lack of funding, Adams said. Current research is being funded by the company itself, Cox added.
Other pharmaceutical companies, including Johnson & Johnson and GlaxoSmithKline, have been involved in the production of Ebola vaccines. Two of the vaccines that are farthest along in the regulatory process have proceeded to Phase I clinical trials with five others following, said WHO assistant director-general of Health Systems and Innovation Marie-Paule Kieny in a press conference last week. Due to the urgency of the Ebola epidemic, efficacy trials will be carried out simultaneously, rather than waiting for the results of the clinical trials, she added.
“Regulatory authorities in countries where the vaccines are manufactured and in Africa will need to work closely with manufacturers and extremely short timelines to find ways to overcome a number of hurdles in the licensing regulation of these vaccines,” Kieny said.
Lack of funding has been an obstacle to the development of an Ebola vaccine, said School of Public Health Dean Paul Cleary. According to Adams and Cox, the unwillingness to finance Ebola research before the current outbreak stemmed from a lack of optimism that the disease could be controlled. Past outbreaks have had fatality rates of up to 90 percent — fatality rates in the current epidemic hover around 50 to 70 percent.
Smaller companies like Protein Sciences do not have the resources to pay for the full development, evaluation and production process for a vaccine, Adams said, adding that the five to 20 million dollar price tag for the production of one million doses is daunting even for large companies. What is more, Protein Sciences is no giant in the pharmaceutical industry — in 2012, it reported revenue of $31 million.
During the SARS outbreak between 2002 and 2004, Protein Sciences developed a vaccine against the virus. But by the time the vaccine was ready for approval, the outbreak had ended, so funding was cut and the vaccine never proceeded to trials, Adams said.
“If funding hadn’t dried up, there would be a vaccine out there,” Adams said.
According to Cleary, many Ebola research studies have not been financed as a result of large cuts in federal science funding. Those cuts are a reflection of the decreased budgets of the NIH and the Centers for Disease Control and Prevention, said Congresswoman Rosa DeLauro, a ranking member of the House Appropriations subcommittee that oversees funding of organizations within the Department of Health and Human Services.
The sequester, which began in March 2013 and required across the board budget cuts for the federal government, slashed the budgets of the NIH and CDC by 5 percent each for fiscal year 2013.
Over the past decade, the budget of the NIH has been cut by 25 percent.