Vaxart initiated preclinical studies for a COVID-19 vaccine in January following reports of the outbreak’s spread across the globe. The candidate is based on the company’s VAASTT oral vaccines platform, which uses adenovirus type 5 (Ad5) as a delivery system for its treatment. In this first round of preclinical testing, all animals that received one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls, Vaxart said this morning. Now, the company plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response.
Wouter Latour, Vaxart’s chief executive officer, called the results of the preclinical study encouraging and said the company will be in a position to select its development candidate within the next few weeks.
“Our oral vaccines have been shown to protect against respiratory infection based on mucosal immunity, the first line of defense for such infections, as recently published in the Lancet Infectious Diseases. This could be important for an effective vaccine that protects the global population from COVID-19. In addition, the Vaxart vaccine would be administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectables in large vaccination campaigns,” Latour said in a statement.
For Vaxart, the positive preclinical news comes about one month after the company entered a development agreement with Emergent BioSolutions Inc. to prepare for cGMP production of an oral COVID-19 vaccine. The first stage of the collaboration is underway and, provided Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine in time to allow the initiation of a Phase I clinical study during the second half of 2020, the company said.