Vaxart Plans to Push COVID-19 Vaccine Candidate into the Clinic

 

Bay Area-based Vaxart, Inc. has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose. Now, the company plans to push one or more into the clinic.

Sean Tucker, Vaxart’s chief scientific officer, said the early preclinical results for the COVID-19 vaccines are in line with the company’s universal flu vaccine candidate, which is now in Phase II testing.

“Additional data will inform us on which candidate we will move forward into clinical trials.  We are particularly interested in vaccine candidates that can generate mucosal immune responses in addition to serum antibody responses.  That is a key feature of our oral vaccines and potentially significant for protection against SARS CoV-2, the virus that causes COVID-19,” Tucker said in a statement.

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.