Vaxart has a development program focused on prophylactic and therapeutic vaccines to address the most common viral infections.
COVID-19:
Vaxart is the first company in the world to have a Phase II clinical trial for an oral COVID-19 vaccine pill.
Hundreds of millions of people world-wide have been infected by COVID-19 and nearly six million have died. Nearly one million have died in the United States alone.
Much of the world remains unvaccinated, and there will continue to be a threat to global public health from mutating variations of SARS-CoV-2. This threat could be substantially reduced by the emergence of an oral room temperature-stable COVID-19 vaccine that could be easily transported and distributed around the world.
Norovirus:
Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the United States.
Each year, on average, norovirus causes 19 to 21 million cases of acute gastroenteritis and leads to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.
Three Phase 1 studies of Vaxart’s norovirus pill vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. The most recent Bivalent Phase 1b study demonstrated subjects obtained robust responses to both the mucosal and the systemic immune system.
Vaxart has completed enrollment in additional norovirus vaccine trials to study the vaccine in an older population as well as to evaluate the optimal timing for boost administration.
Influenza:
Influenza is a worldwide infectious disease, with symptoms that range from mild to life-threatening and sometimes resulting in death. Serious illness occurs not only in vulnerable populations, such as older adults, but also in the general population, especially when unique strains of influenza arise.
In the United States alone, CDC estimates that flu has resulted in 9 million – 41 million illnesses, 140,000 – 710,000 hospitalizations and 12,000 – 52,000 deaths annually between 2010 and 2020.
Vaxart completed Phase 1 trials for an H1N1 influenza A strain and for an influenza B strain, demonstrating safety and immune responses that correlate with protection from influenza.
HPV:
HPV is a group of more than 100 related DNA viruses that can infect the skin or mucous membranes. HPV is the most common sexually transmitted virus in the United States and infection is very prevalent following the onset of sexual activity.
Vaxart is targeting HPV infection that causes cervical dysplasia and cancer due to HPV 16 and 18.
PAST SCIENTIFIC PRESENTATIONS:
- A Phase 2 Double-Blind, Placebo-Controlled Study Showing Oral Tableted Norovirus Vaccine VXA-G1.1-NN is Immunogenic, Efficacious, and Reduces Viral Shedding Following Norovirus Challenge – IDWeek 2024, Dr. Sean Tucker [pdf]
- Evaluating Vaxart’s oral bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females and their nursing infants: VXA-NVV-108 – IDWeek 2024, Dr. Lam Nguyen [pdf]
- Vaxart Monovalent Norovirus Challenge Study Data Review [pdf]
- Vaxart Norovirus KOL Presentation [pdf]
- Potent Immune Responses to Norovirus G1.1 Evaluated in Elderly Subjects following Oral Tablet Delivery in a Phase 1 Placebo-Controlled Study – World Vaccine Congress 2022, Dr. James Cummings [pdf]
- Oral Tablet Vaccination to SARS-CoV-2 Induces Long Lasting Crossreactive Mucosal Antibody Responses in Humans – World Vaccine Congress 2022, Dr. Sean Tucker [pdf]
- Mucosal rAd5 Immunization Against SARS-CoV-2 Spike Elicits Cross-Reactive Nasal and Serum Neutralizing Antibodies and Protects Against Beta Variant Challenge in Non-Human Primates, Dr. Becca Flitter [pdf]
- Oral Tablet Vaccination to SARS-CoV-2 Induces Pan-coronavirus Nasal IgA Responses in Humans, Dr. Sean Tucker [pdf]
- The Importance of T-cell Responses for COVID-19 Vaccines, Dr. Sean Tucker [pdf]