Vaxart (VXRT) Starts Recruitment in Oral COVID-19 Vaccine Study

Vaxart, Inc. VXRT recently announced that it has started recruiting subjects for its phase II study evaluating its oral vaccine tablet for COVID-19.

The company is developing oral recombinant vaccines that are administered by tablet rather than by injection.

Vaxart expects to begin dosing the first of 96 subjects in the United States later this month. The dosing will be split evenly between COVID-19 naïve and mRNA vaccinated subjects. Vaxart’s phase II COVID-19 program will also include countries outside of the United States. The company plans to initiate a study in India later this year.

In August, the FDA cleared Vaxart's Investigational New Drug (IND) application for an S-only oral tablet vaccine candidate. The company will explore multiple S-only constructs in clinical trials alongside the S+N (both S and N proteins) construct that has already completed its phase I study.

In the latest press release, Vaxart stated that its S-only vaccine produced much higher serum antibody levels than the S+N construct did in nonhuman primate studies.  Data from the new trials will enable the company to compare the S-only and S+N vaccine candidates and decide on the best development path forward for its COVID-19 vaccine program, particularly in the face of emerging variant strains.

The stock has rallied 24.4% this year so far against the industry‘s decline of 16.7%.


Zacks Investment ResearchImage Source: Zacks Investment Research

The successful development of an oral vaccine will be a significant boost for Vaxart, given the convenience and ease of an oral formulation over an injection.
Moreover, the emerging strains of COVID-19 have questioned the efficacy of the currently authorized injectable vaccines.  We note that the FDA has approved Comirnaty, a mRNA-based COVID-19 vaccine made by Pfizer PFE and BioNTech BNTX.

Vaxart is also developing an oral tablet vaccine for norovirus, a leading cause of acute gastroenteritis in the United States and Europe.

The company has signed an exclusive worldwide licensing agreement with Altesa Biosciences, Inc. whereby the latter will develop and commercialize Vaxart’s patented formulation of the capsid-binding vapendavir a clinical-stage broad spectrum antiviral.

Vaxart currently carries a Zacks Rank#2 (Buy). Another top-ranked stock in the healthcare sector is Regeneron Pharmaceuticals REGN, which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised upward by 15.4% for 2021 and 5.9% for 2022 over the past 30 days. The stock has soared 13.1% year to date.


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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