The Vaxart tablet vaccine is composed of three basic elements:
The vector: the Ad5 delivery vehicle that carries the DNA “payload” to the gut
The antigen: the pathogen protein designed to trigger the targeted immune response
The adjuvant: a “booster” molecule that stimulates and adds to the immune response
By using the same vector, but with different antigens, Vaxart has designed a modular, scalable and standardized approach to vaccine development.
With this system, we can support the rapid development of numerous vaccines against established targets, as well as against new and emerging pathogens.
We can achieve important synergies – we can use the same manufacturing processes for all of our vaccines.
Three Phase 1 studies of Vaxart’s norovirus tablet vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. The most recent Bivalent Phase 1b study demonstrated subjects obtained robust responses to both the mucosal and the systemic immune system.
Influenza is a worldwide infectious disease, with symptoms that range from mild to life-threatening and sometimes resulting in death. Serious illness occurs not only in susceptible populations, such as older adults, but also in the general population when unique strains of influenza arise.
Respiratory Syncytial Virus (RSV)
Respiratory syncytial virus (RSV) is increasingly recognized as an important cause of respiratory infection. While RSV infections can occur at any age, the elderly and those immunocompromised and living with underlying cardiopulmonary disease are particularly vulnerable.
Human Papillomavirus (HPV)
HPV is a group of more than 100 related DNA viruses that have the ability to infect the skin or mucous membranes. HPV is the most common sexually transmitted virus in the U.S. and infection is very prevalent following the onset of sexual activity. Vaxart is targeting HPV infection that causes cervical dysplasia and cancer due to HPV 16 and 18.
Vaxart’s COVID-19 Vaccine Selected
for the U.S. Government’s Operation Warp Speed
June 26, 2020 at 8:00 AM EDT
OWS to Test First Oral COVID-19 Vaccine in Non-Human Primates
SOUTH SAN FRANCISCO, Calif., June 26, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, today announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021.
The study is designed to demonstrate the efficacy of Vaxart’s oral COVID-19 vaccine candidate.
“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,” said Andrei Floroiu, Chief Executive Officer of Vaxart Inc. “In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.”
SOUTH SAN FRANCISCO, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its COVID-19 Investigational New Drug (IND) application has been filed with the US Food and Drug Administration (FDA).
“We are very excited to reach this important milestone in advancing our oral COVID-19 vaccine candidate towards the clinic,” said Andrei Floroiu, chief executive officer of Vaxart. “We expect our upcoming Phase I study to generate data that will further differentiate our oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19. We believe that this mechanistic benefit combined with the significant advantages of oral administration to the patient while eliminating the need for cold chain distribution, could make our COVID-19 vaccine an ideal candidate for successful mass vaccination campaigns globally.”
“Filing the IND is the first major step of many we are taking to advance our oral vaccine in the prevention of COVID-19,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “We are excited to be moving this project toward clinical trials, and potentially demonstrating similarly potent mucosal and systemic immune responses like we have seen with our other vaccine candidates using the same oral tablet vaccine platform.”
Emergent BioSolutions Signs Development and Manufacturing Agreement
with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease
GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.
VXRT Investor Relations
F.D.A. great read KindredBio Partners with Vaxart for COVID-19 Oral Vaccine
October 9, 2020
$VXRT THEN 1. Oral formulations vs Liquid inoculations
[remember $KIN has partnered wit $VXRT]
1. Oral formulations make for easier storage and transport
When most people think of vaccines, they think of a syringe filled with liquid which is administered by a healthcare worker into the muscles or veins of the patient.
In contrast, Vaxart's technology platform produces oral tablets containing the equivalent active components.
This may seem like a minor distinction,
but it's actually a critical factor that works strongly to Vaxart's advantage when it comes to currying favor with doctors and other providers.
Liquid inoculations typically require refrigeration during manufacturing, shipping, and storage at the point of use.
If they aren't consistently kept at the correct temperature, their efficacy may drop, or they may spoil completely.
This means that traditional liquid vaccines imply a substantial logistical burden on healthcare systems,
as well as their suppliers, as a result of the additional refrigeration hardware and energy expenditures required.
Vaxart's tablets are stable at room temperature, however,
so healthcare systems won't need to spend nearly as much to transport or store its coronavirus prophylactic,
and the risk of spoilage is much low
2. Tablets don't require any consumables to administer
When patients get an inoculation in tablet form, there's no need
for the clinic that distributed it to purchase additional disposable syringes, sterilizing swabs, bandages, or even gloves.
As a bonus, after the patient has taken the vaccine, clinics won't
need to pay for additional biohazard trash removal services to dispose of the used materials.
Thanks to the sum of these savings, healthcare systems won't need to spend as much to administer Vaxart's candidate as they might with a traditional liquid inoculation,
enabling them to vaccinate more patients than they could otherwise.
If these savings seem like they might be trivial, consider that an effective coronavirus prophylactic program would need to be deployed
to about 3 billion people globally,
which could easily create shortages and price spikes for the basic healthcare materials or services required for traditional liquid vaccinations.
3. Less risky self-administration
You've probably taken pills without a doctor or nurse standing at
your side to supervise,
but it's unlikely that you've ever prepared and self-injected a vaccination on your own.
With an oral tablet, Vaxart hopes that patients will have the freedom
to vaccinate themselves in the safety of their homes.
This would be particularly advantageous because it would nullify the risk of patients getting infected in crowded clinics while waiting for their turn to be inoculated.
Vaxart's inoculations win via superior logistics, but oral vaccines aren't for everyone
Vaxart's shelf-stable, syringe-free, and easy-to-deploy prophylactic tablets would thus be popular among clinicians around the world thanks to their lower costs,
and savvy investors should recognize that these advantages could be decisive for future earnings.
However, there is one reason why doctors in underdeveloped regions might not favor Vaxart's candidate.
While the scientific consensus is still forming,
it may be the case that malnutrition makes oral vaccination less effective compared with intramuscular vaccination, especially in children.
Therefore, clinics in areas with low food security might opt for a traditional formulation instead of Vaxart's solution.
Even with this potential disadvantage, I think that the vaccine's logistical strengths -- should it be approved
-- will give the company an enduring advantage over the competition.
Time will tell whether Vaxart's coronavirus candidate can live up
to the necessary medical standards. In the meantime, look for the company's phase 1 clinical trial to start later in the summer.
Alex Carchidi has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned.
The Motley Fool has a disclosure policy.
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