Vaxart Announces Additional Data from Hamster Challenge Study of its Oral COVID-19 Vaccine



Robust Immune Response and Significantly Reduce Viral Load

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., (NASDAQ: VXRT), a medical-level biotechnology agency growing oral vaccines which might be administered via way of means of pill as opposed to via way of means of injection, introduced nowadays extra outcomes from its Hamster Challenge Study:

  • Significant discount in lung viral load of four-five logs in hamsters that obtained oral vaccine doses, in comparison to non-vaccinated animals.

  • Potent induction of antibody response, with serum IgG antibody titers above 10,000 in hamsters that obtained oral vaccine doses.

  • Oral vaccination included in addition to intranasal vaccination towards intranasal undertaking with recognize to key indicators: safety from weight loss, safety from boom in lung weight, viral load discount, and induction of serum IgG antibodies, demonstrating that mucosal safety via way of means of each routes of management became comparable.

As formerly introduced, all hamsters that obtained oral doses of Vaxart’s COVID-19 vaccine candidate confirmed no systemic weight loss, a key indicator of safety towards COVID-19 on this animal version. By contrast, the unvaccinated animals misplaced about 9% general weight. Additionally, unvaccinated hamsters had over times (2x) the relative lung weight of orally vaccinated hamsters, a touchy indicator of significant ailment that correlates with the viral load findings.

“These extra facts offer in addition proof helping the efficacy cappotential of our oral COVID-19 vaccine candidate,” stated Andrei Floroiu, leader government officer of Vaxart. “In addition, we agree with that our room-temperature-strong oral pill vaccine could be a greater convenient, greater sensible strategy to the COVID-19 pandemic in comparison to cold-chain established injectable vaccines.”

The take a look at evaluated Vaxart’s recombinant adenoviral vaccine, with doses administered at zero and four weeks. Animals had been challenged with SARS-CoV-2 at week 8. Hamsters are taken into consideration an remarkable version for assessing COVID-19 contamination seeing that they may be inflamed thru the intranasal route, and, if inflamed, they exhibit medical signs and symptoms consisting of weight loss, worked respiration and ruffled fur. Furthermore, hamsters additionally increase lung problems much like the ones visible in humans. Images of hamsters inflamed with SARS-CoV-2 monitor extreme lung harm similar to what has been located in inflamed human lungs, which include extreme, multi-lobular floor glass opacity, and areas of lung inflammation.

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About Vaxart

Vaxart is a medical-level biotechnology agency growing a variety of oral recombinant vaccines primarily based totally on its proprietary transport platform. Vaxart vaccines are designed to be administered the usage of pills that may be saved and shipped with out refrigeration and get rid of the chance of needle-stick harm. Vaxart has believes that its proprietary pill vaccine transport platform is appropriate to supply recombinant vaccines, positioning the agency to increase oral variations of presently advertised vaccines and to layout recombinant vaccines for brand spanking new indications. Its improvement applications presently encompass pill vaccines designed to shield towards coronavirus, norovirus, seasonal influenza and respiration syncytial virus (RSV), in addition to a healing vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication. Vaxart has filed wide home and worldwide patents protecting its proprietary generation and creations for oral vaccination the usage of adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press launch carries forward-searching statements that contain great dangers and uncertainties. All statements, apart from statements of ancient facts, protected on this press launch concerning Vaxart’s strategy, prospects, plans and objectives, outcomes from preclinical and medical trials, commercialization agreements and licenses, ideals and expectancies of control are forward-searching statements. These forward-searching statements can be followed via way of means of such phrases as “have to,” “agree with,” “should,” “cappotential,” “will,” “anticipated,” “plan” and different phrases and phrases of comparable meaning. Examples of such statements encompass, however aren't constrained to, statements referring to Vaxart’s cappotential to increase (which include enrolling a enough wide variety of topics and production enough portions of its product applicants) and commercialize its COVID-19 vaccine candidate and preclinical or medical outcomes and trial facts (which include plans with recognize to the COVID-19 vaccine product applicants); expectancies concerning the timing and nature of destiny bulletins which include, the ones associated with medical trials and outcomes of preclinical research; Vaxart’s expectancies with recognize to the essential blessings it believes its oral vaccine platform can provide over injectable alternatives, especially for coronaviruses; the cappotential applicability of outcomes visible in our preclinical research or trials to people who can be visible in human research or medical trials; the anticipated position of mucosal immunity in blocking off transmission of COVID-19; and Vaxart’s expectancies with recognize to the effectiveness of its merchandise or product applicants, which include Vaxart’s cappotential position in mitigating the effect of COVID-19 globally. Vaxart might not virtually acquire the plans, perform the intentions or meet the expectancies or projections disclosed withinside the forward-searching statements and also you have to now no longer location undue reliance on those forward-searching statements. Actual outcomes or occasions should fluctuate materially from the plans, intentions, expectancies and projections disclosed withinside the forward-searching statements. Various essential elements should purpose real outcomes or occasions to vary materially from the forward-searching statements that Vaxart makes, which include uncertainties inherent in studies and improvement, which include the cappotential to satisfy expected medical endpoints, graduation and/or final touch dates for medical trials or preclinical research, regulatory submission dates, regulatory approval dates and/or release dates, in addition to the opportunity of damaging new medical facts and in addition analyses of present medical facts; the chance that medical trial and preclinical take a look at facts are challenge to differing interpretations and checks via way of means of regulatory government; whether or not regulatory government can be happy with the layout of and outcomes from the medical research; selections via way of means of regulatory government impacting labeling, production processes, and protection that might have an effect on the provision or industrial cappotential of any product candidate, which include the opportunity that Vaxart’s product applicants might not be authorised via way of means of the FDA or non-U.S. regulatory government; that, even supposing authorised via way of means of the FDA or non-U.S. regulatory government, Vaxart’s product applicants might not acquire wide marketplace acceptance; that a Vaxart collaborator might not reap improvement and industrial milestones; that Vaxart or its companions may also enjoy production problems and delays because of occasions within, or out of doors of, Vaxart’s or its companions’ control, which include the current outbreak of COVID-19; problems in manufacturing, especially in scaling up preliminary manufacturing, which include problems with manufacturing expenses and yields, fine control, which include balance of the product candidate and fine warranty testing, shortages of certified employees or key uncooked materials, and compliance with strictly enforced federal, state, and overseas regulations; that Vaxart might not be capable of attain, hold and put into effect important patent and different highbrow belongings safety; that Vaxart’s capital sources can be inadequate; Vaxart’s cappotential to attain enough capital to fund its operations on phrases suitable to Vaxart, if at all; the effect of presidency healthcare proposals and policies; aggressive elements; and different dangers defined withinside the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does now no longer expect any responsibility to replace any forward-searching statements, besides as required via way of means of law.

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