While GlaxoSmithKline’s first-of-a-kind malaria vaccine, Mosquirix, is tied up with pilot project obligations, a competitor may be nearing in Sanaria’s PfSPZ. The candidate won the FDA’s fast-track designation this week, giving the biotech a boost as it works toward licensure.
With the classification, Rockville, MD-based Sanaria will have increased access to the FDA and its personnel to push forward with a whole malaria parasite vaccine supported by the NIH, the U.S. Military, and multiple energy companies plus government funders and collaborators in Africa.
Ideally, the vaccine could be used in mass immunization campaigns as well as by military personnel, diplomats, businesspeople and others traveling to areas where they risk malaria infection, Sanaria CEO Stephen Hoffman told FiercePharma.
“Such a vaccine has to have very high-level protective efficacy against infection,” he said. “That’s the kind of vaccine our vaccine has shown to be so far.”
The FDA designation comes after Phase I data in 2013 showed that the vaccine protected 100% of subjects three weeks following the final dose. After 14 months, 55% of subjects were protected, according to data released in May.
“The fact that we have gotten this designation is another indication of just how we're progressing in the path toward licensure, recognizing that there's always pitfalls along the way,” Hoffman said. He added that he believes the fast track “will help us get over the finish line.”
Next, Sanaria plans to analyze ongoing and completed studies to finalize its dosing regimen, likely to occur next spring. Then, it’s shooting to start a pivotal Phase III trial late next year.
Though not a household name in biopharma, Sanaria has influential backers ranging from governmental entities, both in the U.S. and Africa, to industry and academia. Last year, it rounded up $48.5 million in support committments from Marathon Oil, Noble Energy, Atlantic Methanol Production Company and the government of Equatorial Guinea to fund mid- and late-stage trials. The energy companies have large workforces in malaria-endemic areas.
For several years, about 100 stakeholders from around the world have met on a regular basis to share trial data in real time and shape future trial design, Hoffman said, an uncommon approach to vaccine development. The support so far has been “unprecedented in that we have been able to establish partnerships and get funds invested in clinical trials by African governments, which we believe is unique,” the CEO said.
GSK’s malaria vaccine, Mosquirix, hit a roadblack last fall as the WHO recommended the vaccine be used in local pilot projects to test real-world efficacy before a wide rollout. That recommendation threw a wrench in the launch of a vaccine already seen as far from perfect; according to trial data, its already limited efficacy wanes over time.
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