The worldwide Zika vaccine race has reached a new milestone as Plymouth Meeting, PA’s Inovio Pharmaceuticals ($INO) says it has received the first approval to begin human testing on its candidate, GLS-5700.
With the FDA's green light, Inovio takes a step ahead of vaccine developers including those at the National Institutes of Health and India’s Bharat Biotech, both of which have been said to be in leading positions in the race, as well as Big Pharma vax player Sanofi ($SNY). Inovio’s Phase I study will test GLS-5700 in 40 healthy subjects using the biotech's DNA delivery system Cellectra.
Inovio says its candidate, developed in conjunction with South Korea’s GeneOne and academics in the U.S. and Canada, has succeeded in large and small animal models to this point. The team will now seek to apply the progress to humans, starting with dosing in the coming weeks. Interim Phase I results are anticipated yet this year, Inovio CEO J. Joseph Kim said in a statement.
Kim, speaking with Bloomberg Video, said however that a vaccine could take years to reach the market. The company has been designing its vaccine since late last year and progressed to human trials "within 6 months," he added.
So far, the current Zika outbreak has spread to 58 countries and territories worldwide, resulting in scores of babies with microcephaly and sparking a global scramble for an effective vaccine.
Sanofi, seeking to apply its decades of experience in the flavivirus dengue, has said it’s working on Zika, while other leading vaccine makers--GlaxoSmithKline ($GSK), Merck ($MRK), Johnson & Johnson ($JNJ) and Pfizer ($PFE)--have all said they’re weighing their options. Reports last month said that some pharma are taking a cautious approach to the outbreak as they seek assurance that a potential vaccine could recoup research costs.
The NIH has said it’s hoping to start a human trial on its candidate yet this year, while Sanofi has previously said it could start clinical studies next year if all goes well.