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Vaxart, Inc. (VXRT)

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       TECHNOLOGY

The proprietary VAAST™ oral vaccine platform uses state-of-the-art recombinant technology that allows modular creation of a wide range of vaccines.

 

      Our Proprietary VAAST™ Platform

Vaxart uses a specific virus called adenovirus type 5 (Ad5) as part of its novel VAAST™ platform to help train our immune system to recognize and defeat dangerous invading pathogens. Vaxart recombinantly removes the DNA Ad5 uses for viral replication, so the virus cannot make copies of itself.
Vaxart then uses the disabled Ad5 virus as a delivery system, or “vector,” to carry the genes coding for the “antigen,” a component of the target virus that is known to generate a protective immune response, and the “adjuvant,” a molecule that stimulates the innate immune system. The Ad5 vector delivers these two genes to the epithelial cells lining the mucosa of the small bowel.
When the altered Ad5 virus enters a cell and delivers the genes for the antigen and the adjuvant, the genes are expressed, and the cell manufactures the vaccine antigen for the immune system to recognize, as well as the adjuvant that stimulates the immune system to mount a targeted response against the vaccine antigen.
These two molecules “teach” the immune system to recognize the antigen, a specific component of the pathogen. The next time the same antigen appears in the body, as part of a new infection, the immune system is prepared to mount a rapid and overwhelming response.
VAAST™ = Vector-Adjuvant-Antigen Standardized Technology

 

   Modular Vaccine Creation

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.

 

Current Pipeline

https://vaxart.com/pipeline/

Norovirus
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
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.”
 

Vaxart Announces IND Filed for COVID-19 Vaccine

August 10, 2020 at 8:00 AM EDT

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.

https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-development-and-manufacturing-0
 

 

VXRT Investor Relations

$VXRT THEN 1. Oral formulations vs Liquid inoculations
[remember $KIN has partnered wit $VXRT]
https://www.fool.com/investing/2020/08/13/3-reasons-doctors-will-prefer-vaxarts-coronavirus/

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.

 



https://www.otcmarkets.com/stock/VXRT/disclosure
https://www.otcmarkets.com/stock/VXRT/security
https://www.otcmarkets.com/stock/VXRT/profile
https://www.otcmarkets.com/stock/VXRT/quote
https://www.otcmarkets.com/stock/VXRT/overview



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VXRT News: Current Report Filing (8-k) 09/15/2020 06:18:58 AM
VXRT News: Statement of Changes in Beneficial Ownership (4) 08/27/2020 08:18:37 AM
VXRT News: Initial Statement of Beneficial Ownership (3) 08/27/2020 08:16:29 AM
VXRT News: Current Report Filing (8-k) 08/27/2020 08:10:33 AM
VXRT News: Statement of Changes in Beneficial Ownership (4) 08/14/2020 04:23:21 PM
PostSubject
#4465  Sticky Note 3 Small-Cap Coronavirus Stocks That Could Skyrocket YJ4LIFE 08/02/20 05:58:28 PM
#5292   Got back in after hours @ 7.95. muneeflo 09/17/20 11:59:48 PM
#5291   You’re okay until the next news hit. Good YJ4LIFE 09/17/20 09:13:28 PM
#5290   * * $VXRT Video Chart 09-17-2020 * * ClayTrader 09/17/20 04:06:58 PM
#5289   Any worry of an offering? I always get bcapps66 09/17/20 12:53:19 PM
#5288   That’s big time resistance In the 9s. Pass YJ4LIFE 09/17/20 11:35:03 AM
#5287   It's a kind of psychological warfare, trust in DD... Pisd 09/17/20 10:35:26 AM
#5286   Kicking myself. I sold at 7.04. I said muneeflo 09/17/20 10:32:11 AM
#5285   yep in and out multiple times.. $treet $inatra 09/17/20 10:18:22 AM
#5284   VXRT will test 9.5 and retrace a bit. ursa 09/17/20 10:04:57 AM
#5283   nice pop to $9 so far.. lets see $treet $inatra 09/17/20 09:58:55 AM
#5282   Yes there is I have posted summary below xray168 09/17/20 09:53:52 AM
#5281   Running hard but not seeing any new news. joro44 09/17/20 09:48:47 AM
#5280   Word getting out another horse in the race VXRT$... Pisd 09/17/20 08:36:54 AM
#5279   Oral COVID-19 vaccine candidate to enter Phase I Tamtam 09/17/20 03:20:05 AM
#5278   The studies summarized within this section demonstrated that xray168 09/17/20 02:11:08 AM
#5277   An oral formulation could greatly facilitate vaccine administration, xray168 09/17/20 01:55:13 AM
#5276   Vaxart has conducted preclinical studies to determine the xray168 09/17/20 01:40:43 AM
#5275   September 16, 2020 YJ4LIFE 09/17/20 01:21:17 AM
#5274   I think so. The EU patent approval today YJ4LIFE 09/17/20 01:11:08 AM
#5273   More good news are coming. Exciting!!!! YJ4LIFE 09/17/20 01:09:32 AM
#5272   Big day tomorrow kreeech 09/16/20 11:25:26 PM
#5271   We need to knock down that $8.25 wall... bleu22 09/16/20 07:52:25 PM
#5270   UP BIG AFTER HOURS! mcnierney1 09/16/20 07:46:28 PM
#5269   https://youtu.be/X-Nhrl3S8Yo YJ4LIFE 09/16/20 07:07:46 PM
#5268   Maybe funding news is coming this month! Crystal ball.... ursa 09/16/20 06:33:42 PM
#5267   LOL. YOU ARE A PROPHET. I DUMPED VXRT otcmoneydoubler 09/16/20 06:30:16 PM
#5266   US20180161458 - FORMULATIONS FOR SMALL INTESTINAL DELIVERY OF YJ4LIFE 09/16/20 05:32:47 PM
#5265   Vaxart Can Still Be a Major Force in YJ4LIFE 09/16/20 04:49:55 PM
#5264   * * $VXRT Video Chart 09-16-2020 * * ClayTrader 09/16/20 04:21:08 PM
#5263   Sinatra will chase this very soon... he is ursa 09/16/20 12:58:23 PM
#5262   This one trades like penny stock. The float ursa 09/16/20 11:56:10 AM
#5261   I was gonna say... the devil got involved YJ4LIFE 09/16/20 11:27:54 AM
#5260   Can't even cheerlead, trades all over the map ... Pisd 09/16/20 11:16:56 AM
#5259   Are we there yet? LOL LOL LOL. The YJ4LIFE 09/16/20 11:12:24 AM
#5258   LOL LOL LOL!!!! YJ4LIFE 09/16/20 11:10:31 AM
#5257   I was gonna hold, but when it moves muneeflo 09/16/20 11:02:07 AM
#5256   Sold @ 7.05 on the run up to muneeflo 09/16/20 11:01:26 AM
#5255   just stick with support & resistance and play $treet $inatra 09/16/20 10:53:53 AM
#5254   Same, like the company and story, but struggling Pisd 09/16/20 10:51:31 AM
#5253   I play both long and short. Right now $treet $inatra 09/16/20 10:45:18 AM
#5252   Curious? short seller, or wanting to buy gap-fill? ... Pisd 09/16/20 10:42:32 AM
#5251   VXRT trying to break through resistance - denied $treet $inatra 09/16/20 10:39:36 AM
#5250   nasdaq ticker for long time, no pink sheet.. VXRT$... Pisd 09/16/20 10:35:53 AM
#5249   Yes its nasdaq now, but it still trades ccfume 09/16/20 10:15:43 AM
#5248   Yep, Its a stinky pinky. Months ago this ccfume 09/16/20 10:08:01 AM
#5247   VXRT is NASDAQ, guys and it's running right now. muneeflo 09/16/20 09:46:06 AM
#5246   Do you even know what a pink sheet pcjockey 09/16/20 09:19:14 AM
#5245   VXRT 6.25 ouch. We are starting off red. muneeflo 09/16/20 08:43:48 AM
#5244   Average down to get out of this ccfume 09/16/20 07:32:18 AM
#5243   I left a lot on the table here Pisd 09/16/20 06:55:22 AM
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