Vaxart Announces Positive Preclinical Data for its Oral COVID-19 Vaccine Program

Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, recently announced it has obtained positive preclinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose.

“These early preclinical results are in line with those for our oral influenza vaccine, which was protective in a clinical Phase 2 efficacy study,” said Sean Tucker, PhD, Chief Scientific Officer of Vaxart. “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.”

In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAAST oral vaccines platform. The company is currently evaluating multiple vaccine candidates in its preclinical models. 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 2 weeks after the first vaccination. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls. Vaxart 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.

On March 18, 2020, Vaxart entered into an agreement with Emergent BioSolutions Inc. for development services 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 1 clinical study during the second half of 2020.

“These results are extremely encouraging, and we should be in a position to select a lead development candidate for cGMP manufacturing and clinical testing in the coming weeks,” said Wouter Latour, MD, Chief Executive Officer of Vaxart Inc. “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.”

Vaxart is a clinical-stage biotechnology company primarily focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxart’s vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, visit www.vaxart.com.

Brant Biehn
Vaxart Inc
650 550 3500
IR@vaxart.com