Vaxart (NASDAQ:VXRT), 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%.
Image 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 (NASDAQ:REGN) 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $2.4 trillion by 2028 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Recommendations from previous editions of this report have produced gains of +205%, +258% and +477%. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Pfizer Inc. (NYSE:PFE): Free Stock Analysis Report
VAXART, INC. (VXRT): Get Free Report
BioNTech SE Sponsored ADR (NASDAQ:BNTX): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research