March 25, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO – California-based startup Vaxart may have the key to safely and efficiently delivering a vaccine for the mosquito-borne Zika virus to even the most remote regions—developing a stable oral treatment in a tablet form.
Vaxart, a privately held clinical-stage company, developed its own technology for a tablet formulation of recombinant vaccines, which are traditionally administered as an injectable.
The company, which currently has 25 full-time employees, recently experienced success for this platform with its H1 influenza vaccine. The Phase I study generated broad antibody and T-cell responses after just one dose to the target virus with the oral tablet medication. This same delivery platform is being explored to develop a tablet vaccine for the Zika virus.
Wouter Latour, Vaxart’s chief executive officer, told BioSpace in an exclusive interview that the tablet platform would allow the vaccine to be stored and shipped without the need of refrigeration and could be administered without relying on a lot of professional medical staff. Latour said the tablet form of the vaccine would have a competitive profile when compared to traditional injectables.
“This (virus) is bad news all around and doesn’t seem to show signs of stopping. This tablet-form vaccine could make a huge difference in the areas most impacted,” Latour said.
With no available vaccine or treatment, the World Health Organization declared Zika virus an international public health emergency. As the Zika virus spread throughout parts of South and Central America, Africa and Southeast Asia, Latour said Vaxart was able to pivot its technology to focus on a tablet form of the vaccine. Although Vaxart is a small enterprise, Latour said Vaxart wanted to be as responsive as it could to the Zika outbreak. When news of the widespread impact of the virus hit, Latour said Vaxart “dove into” studying if its technology could be adapted. The company has now initiated preclinical testing of an oral vaccine for Zika virus.
“We feel strongly this approach could be helpful with the disease,” Latour said. The Zika virus is a mosquito-borne disease that causes mild flu-like symptoms in most people. In pregnant women, it may be linked to an increased rate of microencephaly, a neurodevelopmental disorder characterized by a smaller-than-normal head and brain size. Life expectancy for individuals with microencephaly is reduced and the prognosis for normal brain function is poor. The virus may also be linked to an autoimmune disorder of the nervous system called Guillain-Barré syndrome.
If the vaccine does receive a Fast Track style designation from the U.S. Food and Drug Administration, Latour said the company would be able to move quickly to make the tablet available to those needing it.
“With a tablet, more people are going to be willing to take it. You don’t have to have medical staff to deliver it,” Latour said. “This will take less time and cost less, which we believe will make distribution much easier.”
Although Latour believes the company’s experimental vaccine could benefit from a possible accelerated approval program, it would still be years before a vaccine could pass all regulatory hurdles.
While the Zika vaccine could generate a lot of new interest in Vaxart’s platform, it’s the company’s influenza vaccine that’s propelling the company forward. In October, Vaxart was awarded a $14 million grant by the Office of Biomedical Advanced Research and Development Authority (BARDA) to fund a Phase II challenge study. In this study, Vaxart’s vaccine will be tested against a traditional injectable and a placebo. Latour said he anticipates data from the Phase II trial in 2017.
“We’re delighted with BARDA having interest in our study, which could be a breakthrough with the technology,” Latour said.
In addition to its influenza and Zika vaccines, Vaxart is also focusing its technology to develop tablet vaccines for respiratory syncytial virus (RSV) and norovirus. Vaxart will move into clinical trials with the RSV and norovirus vaccines later this year, Latour said.
“We’re really moving beyond flu into promising areas,” Latour said. “This is such fulfilling research. It’s why I went into my profession. Preventing illnesses is very satisfying.”
