Vaxart Announces Positive Hamster Challenge Study Data for its Oral COVID-19 Vaccine
“Our oral vaccine showed that 100% of hamsters receiving two oral doses of vaccine in the study were protected against systemic weight loss, as well as lung weight gain, which is a key indicator of lung damage due to infection,” said
The study evaluated Vaxart’s recombinant adenoviral vaccine, with doses given at 0 and 4 weeks. Animals were challenged with SARS-CoV-2 at week 8. Topline data demonstrated that all unvaccinated animals lost at least 8% of their body weight, and all showed evidence of lung disease as measured by relative weight gain in the lungs. By contrast, all animals vaccinated with two doses of the oral vaccine maintained or gained body weight by the end of the experiment, a statistically significant result (p<0.001). Additionally, these animals were protected against the lung weight gain seen in the unvaccinated animals (p<0.001). For unvaccinated animals, lung weight as a percentage of body weight was approximately twice that of the animals that received two oral doses of the vaccine. The experiment was designed to monitor systemic weight for 5 days before animals were assessed for lung disease. N=8 per group. Hamsters receiving one oral dose had partial protection. Full results from the study will be published when data analysis is complete.
“We are happy that just as we dosed the first human subjects in our Phase 1 clinical trial, we showed indicators of protection against COVID-19 in an animal challenge study. These results support the efficacy potential of our oral COVID-19 vaccine candidate suggested by our earlier pre-clinical data,” said
Hamsters provide a very sensitive model for assessing COVID-19 infection since they can be infected via the intranasal route, and, if infected, they demonstrate pronounced clinical symptoms such as weight loss. They can also show signs such as labored breathing and ruffled fur. They also develop lung issues similar to those seen in humans. Images of hamsters infected with SARS-CoV-2 reveal severe lung injury similar to that seen in infected human lungs, including severe, multi-lobular ground glass opacity, and regions of lung inflammation and consolidation.
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
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This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop (including enrolling a sufficient number of subjects and manufacturing sufficient quantities of its product candidates) and commercialize its COVID-19 vaccine candidate and preclinical or clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations regarding the timing and nature of future announcements including, those related to clinical trials and results of preclinical studies; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses; the potential applicability of results seen in our preclinical trials to those that may be seen in human studies or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart’s expectations with respect to the effectiveness of its products or product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19 globally.
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Source: Vaxart, Inc.