Price action is very important when it comes to trading and investing. On a day when COVID-19 vaccine plays dropped on the news that Russia approved a new vaccine, VXRT stock was the only biotech to rise. This is a strong indication that investors not only booked profits in big names like Moderna and Novovax but that some of that buying went into Vaxart.
We told our readers and subscribers back in June to get out of Moderna and into VXRT stock, which you can read here. While VXRT stock did run to $17.49, the stock has since pulled back. We believe this presents another opportunity for investors to get in before Vaxart stock runs to new highs. As we take a closer look, there’s a lot to like with VXRT stock.
First up, here’s a little background info for those that aren’t familiar with VXRT stock. Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and have the potential to provide sterilizing immunity for diseases such as COVID-19. Vaxart believes that a room temperature stable tablet vaccine is easier to distribute, store and administer than injectable vaccines and may provide significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV).
IND Filed For COVID-19 Vaccine
One of the many reasons to be bullish on VXRT stock is its COVID-19 Investigational New Drug (IND) application filed with the US FDA on Monday. This is the first step in advancing its oral COVID-19 vaccine candidate towards the clinic. This upcoming Phase I study will further differentiate Vaxart’s oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19.
Vaxart’s coronavirus vaccine candidate is based on its proprietary oral vaccine platform, VAAST. To date, Vaxart has conducted multiple clinical trials with vaccines based on its VAAST platform, demonstrating its oral tablet vaccines consistently generate robust mucosal responses in humans. In addition, Vaxart’s vaccines have demonstrated efficacy in humans for H1 influenza, and in pre-clinical models for chikungunya, aerosolized Venezuelan Equine Encephalitis (VEE) and Respiratory Syncytial Virus (RSV). Worth noting is that the VAAST platform has never failed neither a pre-clinical nor a clinical trial. The odds of success are very high.
VXRT Stock And Operation Warp Speed
Operation Warp Speed is a new national program aiming to provide substantial quantities of a safe, effective vaccine for Americans by January 2021. The program originally began when the White House selected 5 candidates in early June. They included candidates from Moderna, AstraZeneca, Johnson & Johnson, Merck, and Pfizer. Joining this prestigious list in June was VXRT stock with its oral COVID-19 vaccine. Vaxart will participate in a non-human primate (NHP) challenge study. The study is designed to demonstrate the efficacy of Vaxart’s oral COVID-19 vaccine candidate. Andrei Floroiu, Chief Executive Officer of Vaxart Inc, said:
“We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated. SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa – nose, mouth, or eyes – strongly suggesting that mucosal immunity could serve as the first line of defense. In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.”
Why An Oral Vaccine Is Better
VXRT stock is the ONLY company in Operation Warp Speed with an oral, room-temperature-stable tablet. Its technology has “the potential to offer superior protection against airborne viruses such as SARS-CoV-2 by triggering both mucosal and systemic immunity” – it might be the only current COVID-19 candidate that will be able to introduce a front-line response that works directly with the mucosal membranes, such as those lining the nose and mouth.
In contrast to a typical vaccine, a tablet offers stability at room temperature. This facilitates distribution and storage since the tablet does not need refrigeration, a typical component of normal injectable vaccinations. Should the COVID-19 tablet prove safety and efficacy in clinical trials, two of the new FDA requirements, the ability to ship and distribute large doses of tablets worldwide would be far easier.
1 Billion COVID-19 Vaccine Doses Minimum
VXRT stock got moving in June after announcing a deal with Attwill Medical Solutions Sterilflow, LP affirming the parties’ intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine. AMS will be assigning dedicated resources and equipment for the scale-up and commercial production of the vaccine upon entering a formal agreement. Andrei Floroiu, CEO of Vaxart Inc, said:
“We believe AMS’ experience coupled with its ability to manufacture a billion or more doses per year would be a beneficial addition to our group of CDMO partners and enable the large scale manufacturing and ultimate supply of our COVID-19 vaccine for the US, Europe and other countries in need. We believe our oral vaccines, generated on our proven platform, have the potential to offer superior protection against airborne viruses such as SARS-CoV-2 by triggering both mucosal and systemic immunity while being administered by a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.”
Preclinical Studies Results
VXRT stock just released preclinical data on its SARS-CoV-2 (COVID-19) vaccine based on Vaxart’s oral adenovirus platform. The data is available on an online preprint server at https://biorxiv.org/cgi/content/short/2020.09.04.283853v1. The findings showed:
- Immunization with the vaccine candidate induced IgA response in the lungs of animals, which is indicative of a mucosal immune response. Of particular note, neutralizing antibodies in the lungs were observed at a very high percentage of the total antibody response.
- Immunization with our vaccine candidate expressing full length S and N proteins induced IgG responses in a dose-dependent manner.
- Antigen-specific CD4+ and CD8+ T cells were induced at both low and high doses.
- Vaccine administration induced only low levels of IL-4 production, suggesting little risk of vaccine- dependent disease enhancement.
Sean Tucker, Ph.D., chief scientific officer of Vaxart, commented:
“The data from these studies suggest that our vaccine candidate is capable of inducing immunogenicity on three levels: first, to induce potent serum neutralizing antibodies to the viral S protein, second to induce a mucosal immune response, and third to induce T cell responses. As we continue to learn more about COVID-19, there is a growing body of evidence that mucosal immunity may become a key factor for the development of an efficacious vaccine. Both mucosal IgA and mucosal T cells have been shown to contribute to sterilizing immunity in other respiratory diseases. Importantly, while systemic immunity is important for controlling the development of illness, it has been suggested that mucosal immunity may be essential for blocking transmission which will be crucial for an effective vaccine campaign. We believe this will be essential in reducing infection rates and eventually eradicating COVID-19 globally.”
VXRT Stock Bottom Line
Currently trading with a $560 million market cap, VXRT stock has enormous potential. The company is now well-funded after raising $90 million over the summer to fund its COVID-19 vaccine clinical trial. As the only oral vaccine candidate in Operation Warp Speed, $90 million in the bank, and a market cap a fraction of Moderna or Novovax, we believe VXRT stock remains one of the best bets for investors in the COVID-19 vaccine space. It’s not a matter of if VXRT stock will reach new highs, but when, especially with 12% of the float short.
As always, good luck to all (except the shorts)
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Disclosure: We have no position in NASDAQ:VXRT or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.