Vaxart Announces Progress in Oral Vaccine Platform and COVID-19 Program
Key Insights
Vaxart completed two Phase 2 clinical studies for its oral norovirus (search) vaccine candidate, establishing proof of concept for both respiratory and GI viruses.
A $9.27 million contract from BARDA will support preparations for a Phase 2b clinical trial evaluating Vaxart's oral COVID-19 (search) vaccine candidate against an approved mRNA (search) vaccine.
Preclinical data demonstrated Vaxart's COVID-19 (search) vaccine candidate's potential to protect against multiple SARS-CoV-2 (search) variants by eliciting strong antibody responses and reducing viral shedding.
Vaxart, Inc. (VXRT) has announced significant advancements in its oral vaccine platform, particularly in its norovirus (search) and COVID-19 (search) programs. The company's progress includes completing Phase 2 clinical studies for its oral norovirus vaccine candidate and securing a contract from the Biomedical Advanced Research and Development Authority (BARDA) to prepare for a Phase 2b clinical trial of its oral COVID-19 vaccine. These developments signal a promising trajectory for Vaxart's innovative approach to vaccine development.
COVID-19 Vaccine Program
In January, Vaxart received a $9.27 million contract from BARDA to prepare for a 10,000-subject Phase 2b clinical trial. This trial will evaluate Vaxart's oral pill COVID-19 (search) vaccine candidate against an approved mRNA (search) vaccine comparator. The study aims to determine the relative efficacy, safety, and immunogenicity of Vaxart's investigational oral SARS-CoV-2 (search) S-BB vaccine tablet in adults previously immunized against COVID-19 infection. The trial may start as early as Q2 2024.
"We are heartened by the government support, which we think is indicative of the potential of our differentiated approach to the continuing challenge that is COVID-19 (search)," said Dr. James Cummings, Chief Medical Officer of Vaxart.
Preclinical Data
Further bolstering the COVID-19 (search) program, Vaxart published preclinical data in the journal Vaccines demonstrating the cross-protective potential of its COVID-19 vaccine candidates. The non-human primate data showed that the vaccine candidates could protect against multiple SARS-CoV-2 (search) variants of concern. The vaccine elicited strong antigen-specific serum IgG (search) and IgA (search) responses with neutralizing activity. Vaccination also reduced SARS-CoV-2 shedding following infectious challenge in both the upper and lower airway of non-human primates.
Norovirus Vaccine Program
Vaxart also made strides in its norovirus (search) program, delivering top-line data from two Phase 2 studies, including a challenge study of its monovalent candidate. The company believes it is on track to identify potential correlates of protection that will aid in the advancement of its bivalent norovirus candidate.
"We believe the data we have shared to date is promising for this vaccine candidate and for our vaccine platform," said Dr. Sean Tucker, Chief Scientific Officer and Founder of Vaxart.
In late 2023, Vaxart completed enrollment in a Phase 1 clinical trial evaluating the ability of its norovirus (search) vaccine candidate to induce antibodies in lactating mothers' breast milk and transfer those antibodies to young infants. Top-line results from this trial are expected in mid-2024. Vaxart plans to meet with the FDA during the second quarter of 2024 to discuss its data on potential correlates, a Phase 2b dose confirmation study, and potentially a G.2 for challenge study.
Financial Update
Vaxart ended 2023 with cash, cash equivalents, and investments of $39.7 million. This cash balance does not include approximately $15 million net proceeds raised in early 2024. The company anticipates its current cash runway extends into the fourth quarter of 2024.