This Oral Vaccine Maker Could Have The Answer We’re All Looking For

How Junior Bay Area Biotech Firm Vaxart Inc. (NASDAQ:VXRT) Jumped Out Months Ahead to Develop the ONLY U.S.-Made Oral Vaccine for Coronavirus (COVID-19)

The war against the coronavirus is well underway, with governments around the world trying to stay in front of this novel disease. What we are witnessing is indeed a historical, deadly pandemic, the likes of which no generation alive today has seen before. The disease’s impact is being felt across communities and economies around the globe, as many are scared by the visuals of empty shelves due to panic buying, and the reality of state-enforced blockades, curfews, and quarantines.

As the general public struggles in confusion with the almost surreal turn of events of the last few months, scientists around the world are fast-tracking research—and vaccines are on the way.

However, where the vaccines are developed and manufactured also matters greatly.

While news of a Chinese Vaccine being approved for human testing seems positive on the surface, on the flip side there are MAJOR domestic concerns over US reliance on Chinese drug producers arising in what’s looking to be an ever-more-ominous trade war brewing.

An despite reports coming out of Israel on progress on another vaccine inside the allied country, other concerns arise, regarding regional stability, thanks to neighbouring Iran’s explosive outbreaks, and other delays are expected to sidetrack progress on that answer. It’s becoming clearer that the best hope for Americans will come from a domestic breakthrough—especially if the US and China go through what’s being dubbed a ‘decoupling’.

Human trials have only recently began in the US, but there are plenty of companies offering their support. Among the US firms developing covid-19 vaccines only ONE company in the country is developing an oral vaccine.

That company is Bay Area based Vaxart, Inc. (NASDAQ:VXRT).

Over a month ahead of some of the country’s largest biotech companies, Vaxart was already initiating its work on their coronavirus vaccine in January of this year. Now the company has recently announced it has entered an agreement with multi-billion-dollar biotech firm Emergent Biosolutions (NYSE:EBS) to develop and manufacture their oral coronavirus (COVID-19) vaccine candidate.

There are potentially several MAJOR benefits to an oral vaccination vs an injected version—which will be discussed below. But given the state of the global economy, supply lines, and other factors, it’s also likely that all the pieces are in place now for Vaxart, Inc. (NASDAQ:VXRT) to truly rise to the occasion in this unprecedented time of need.

Let’s take a closer look at what has Vaxart, Inc. (NASDAQ:VXRT) gaining the interest of analysts, the market, and has led to its recent surge.

MEET VAXART AND THE VAASTtm PLATFORM

Even before it announced its targeting of a coronavirus vaccine, analysts began watching Vaxart, Inc. (NASDAQ:VXRT) with keen interest.

Since last year, Vaxart’s analyst coverage includes:

Ahead of the rush, Vaxart, Inc. (NASDAQ:VXRT) announced initiation of its Coronavirus Vaccine Program on January 31,2020—a wise strategic move that could soon potentially yield them a coveted first-to-market advantage should they gain approval.

Normally vaccines require longer development arcs… but desperate times call for desperate measures. Reports are coming out that researchers are already skipping key animal testing first during this crisis. Not all developers are following this route, but this key change in standard procedure marks the urgency, and potential for faster-than-normal approvals.

The US Food and Drug Administration is having to work overtime during this crisis, including emergency granting of approvals on faster tests, and receiving public calls to fast-track a vaccine. 

So now, more than pre-coronavirus outbreak times, the spotlight will be on companies like Vaxart, Inc. (NASDAQ:VXRT) who are working diligently to get their vaccines ready faster.

SIGNIFICANT VACCINE ADVANTAGES OF ORAL VS INJECTION

Upon the announcement of its agreement with a multi-billion-dollar biotech partner to develop and manufacture its oral vaccine, the CEO of Vaxart, Inc. (NASDAQ:VXRT) highlighted some of the major potential advantages of his company’s product.

“We believe our oral tablet vaccines provide substantial potential advantages, especially when targeting mucosal pathogens such as flu, norovirus, RSV and the recently emerged coronavirus. In addition, the logistical advantages of an oral vaccine that is administered using a convenient room temperature-stable tablet could be of critical benefit when rolling out a major public health vaccination campaign.”

Wouter Latour, MD, chief executive officer of Vaxart.

According to researchers from the University of Texas in Austin, there are several advantages worth noting for oral administration of vaccines:

  • Greater coverage, accessibility
  • Lower costs of administration and distribution
  • More practical access to developing nations with limited resources
  • Self-administration potential
  • Potential reduction of vaccine program costs (less training and mobilization of health care workers) for up to 25% of the cost of introducing a new vaccine
  • Needle-free administration eliminates occupational needle-stick injuries, which occur in approximately 5% of health-care workers each year
  • More costeffective production, since they don’t require the extensive purification necessary for injected formulations.
  • Less biohazardous waste (no needles), which the majority of developing countries simply don’t have the infrastructure to handle
  • With wider accessibility and coverage, oral immunization also has the potential to improve overall vaccine efficacy

Vaxart’s oral vaccines represent an important advance in vaccination technology. They’re designed to generate broad and durable immune responses, including mucosal and systemic responses. The oral route of administration provides a more efficient and convenient method of administration relative to injectable vaccines.

Under the terms of the agreement, development services will begin immediately, and upon Vaxart’s election, Emergent is expected to produce bulk cGMP vaccine allowing Vaxart to initiate a Phase 1 clinical study early in the second half of 2020. 

Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart, Inc. (NASDAQ:VXRT) firmly believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. 

Aside from the state-funded developments in Israel, Vaxart, Inc. (NASDAQ:VXRT) is the ONLY US company to publicly announce development of an oral vaccine for coronavirus (COVID-19).

TIMELINE: DEVELOPMENT WILL BEGIN IMMEDIATELY

Time is of the essence, and Vaxart, Inc. (NASDAQ:VXRT) isn’t wasting a single second.

Cases of pneumonia detected in Wuhan, China were first reported on December 31, 2019, while the virus itself was still unknown. Chinese authorities wouldn’t confirm the identification of the novel coronavirus until January 7, 2020, and the first death wasn’t reported until January 11th. The National Institutes of Health began working on a vaccine on January 20th. The first confirmed case on US soil was reported on January 21st

Vaxart, Inc. (NASDAQ:VXRT) announced its initiation of development of a coronavirus on January 31st… more than a month ahead of most others in the space.

In the world of vaccines, and diseases that spread as fast as this current outbreak… months MATTER. The fastest effort to date was during the Zika outbreak in 2015, which had a vaccine ready for testing in about seven months before the epidemic fizzled out.

But with the coronavirus things are different. 

At a meeting with officials earlier in March, US President Donald Trump said, “I like the sound of a couple months better, if I must be honest.”

So, it’s worth looking at the ongoing efforts of the many companies that have publicly stated their intention to develop a vaccine for this crisis, and how Vaxart, Inc. (NASDAQ:VXRT) stands out from the pack.

Public Coronavirus Vaccine Developers

Company Ticker Symbol Market Cap Share Price Covid-19 Vaccine Initiation Date
Vaxart, Inc. NASDAQ:VXRT $110.69M $2.11 Jan 31, 2020
BioNTech SE  NASDAQ: BNTX $19.92B $87.80 Mar 17, 2020
Pfizer, Inc.  NYSE:PFE $176.25B $31.67 Mar 17, 2020
Gilead Sciences NASDAQ: GILD $96.85B $76.60 Feb 26, 2020
GlaxoSmithKline NYSE: GSK $87.7B $33.96 Feb 24, 2020  Feb 3, 2020 
Inovio Pharmaceuticals NASDAQ:INO $1.03B $7.07 Jan 30, 2020 
Johnson & Johnson NYSE:JNJ $346.23B $131.14 Feb 11, 2020 
Moderna Inc. NASDAQ:MRNA $10.3B $31.32 Jan 13, 2020 
Regeneron Pharmaceuticals NASDAQ:REGN $54B $491 Feb 4, 2020 
Sanofi NASDAQ:SNY $102.32B $40.73 Feb 18, 2020 
Vir Biotechnology NASDAQ:VIR $4.86B $48.24 Jan 22, 2020 
Tonix Pharmaceuticals NASDAQ:TNXP $6.945M $0.56 Feb 26, 2020 
Arcturus Therapeutics NASDAQ:ARCT $207.39M $13.70 Mar 4, 2020 
Heat Biologix NASDAQ:HTBX $32.8M $0.57 Mar 3, 2020 
Applied DNA Sciences NASDAQ:APDN $11.85M $3.40 Mar 2, 2020 
Altimmune, Inc. NASDAQ:ALT $42.75M $2.75 Feb 28, 2020 
Novavax, Inc. NASDAQ:NVAX $569.39M $11.03 Feb 26, 2020

NOTE: All Prices in USD, and reflect midday trading March 18, 2020

It’s clear that Vaxart, Inc. (NASDAQ:VXRT) was among the fastest companies to respond to this crisis, and put their proprietary VAAST™ platform into action.

Of the 17 companies listed above, only FOUR had made announcements before February.

And it’s very important to note that Vaxart, Inc. (NASDAQ:VXRT) is the ONLY company in the US listed above developing an oral vaccine for the Wuhan coronavirus (COVID-19).

MONUMENTAL PARTNERSHIP, MADE IN THE USA

Because Vaxart, Inc. (NASDAQ:VXRT) is developing oral recombinant vaccines administered by tablet rather than by injection, it was able to attract the partnership of Emergent BioSolutions Inc. (NYSE:EBS).

As per the deal, Emergent will deploy its molecule-to-market contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Under the terms of the agreement, development services will begin immediately! Once Vaxart gives the greenlight, Emergent is expected to produce bulk cGMP vaccine allowing Vaxart to initiate a Phase 1 clinical study early in the second half of 2020.  

Emergent will provide development services out of its Gaithersburg, MD location and manufacture drug substance at its Bayview facility in Baltimore, MD, designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services

“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate. We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”

Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions

Accomplished Brain-Trust Leading the Way

Led by Chairman and CEO Wouter Latour, M.D., M.B.A., the Vaxart team is stacked with a team that’s been on the teams of some of the world’s top companies, including SmithKline Beecham, Merck, Novartis, Dow, Dynavax and more.

Dr. Latour previously held executive positions at various pharmaceutical and biotechnology companies including Genelabs, SmithKline Biologicals and Novartis. 

Some other highlighted members of the management team include:

Founder, Chief Scientific Officer and Director, Dr. Sean Tucker, who has held numerous scientific and engineering roles at various biotechnology companies. Dr. Tucker received a B.S. in chemical engineering from the University of Washington, an M.S. in chemical engineering from the University of California, Berkeley, and a Ph.D. in immunology from the University of Washington.

Senior VP Commercial Operation, Brant Biehn is responsible for Business Development and Commercial Readiness for the organization. Earlier, he served as chief commercial officer at Dynavax Technologies Corporation, and held sales and marketing positions of increasing seniority at Merck, culminating in the position of Global Brand Leader with global responsibility for the manufacturing, commercial, clinical and regulatory activities for vaccines such as ZOSTAVAX®, PNEUMOVAX®, RECOMBIVAX HB® and VAQTA®.

Some highlighted directors include:

Michael J. Finney, Ph.D. who formerly served as CEO of Vaxart from 2009 to 2011. He received an A.B. in biochemical sciences from Harvard University and a Ph.D. in biology (genetics) from the Massachusetts Institute of Technology. Dr. Finney has served as a member of Vaxart’s board of directors since July 2007, and currently sits on six private boards. 

Steven Boyd is the Chief Investment Officer of Armistice Capital, a long-short equity hedge fund focused on the health care and consumer sectors based in New York City. 

Bob Yedid hasover 25 years of healthcare experience as a buy-side analyst, portfolio manager, private equity investor and investment banker and since 2014 has been Managing Director of LifeSci Advisors, the largest healthcare dedicated investor relations/public relations firm globally. 

Anne M. VanLent is President of AMV Advisors, providing corporate strategy and financial consulting services to emerging growth life sciences companies. Ms. VanLent also serves as a member of the board of directors and audit committee chair of Ocera Pharmaceuticals, Inc. and Applied Genetics Technologies Corporation (AGTC), both Nasdaq-listed companies. 

Todd Davis is the Founder and Managing Partner of RoyaltyRx Capital, a special opportunities investment firm and has been involved in over $3 billion in healthcare financings including growth equity, public equity turnarounds, structured debt and royalty acquisitions, and has also led, structured and closed over 40 additional intellectual property licenses, as well as hybrid royalty-debt deals. 

Key members of the Advisory Team, include:

John Treanor, M.D. who is the Chief of the Infectious Diseases Division in the Department of Medicine and leader of the clinical core of the Respiratory Pathogens Research Unit at the University of Rochester Medical Center (URMC).

Ann Arvin, M.D. is Lucille Salter Packard Professor of Pediatrics (Infectious Diseases) and Professor of Microbiology and Immunology, Stanford University.

Peter Patriarca, M.D. is Senior Regulatory Consultant, Biologics Consulting Group, and former director of the Division of Viral Products/OVRR at CBER and Vice President Regulatory Affairs, MedImmune.

Harry Greenberg, M.D. is Senior Associate Dean of Research and Director of Spectrum, the NIH-funded Stanford Clinical and Translational Science Center, Professor of Medicine and Microbiology and Immunology, Stanford University School of Medicine, and former Senior Vice President, Research, Aviron (now MedImmune Vaccines, AstraZeneca).

Robert Belshe, M.D. is a Dianna and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology Emeritus and Director of the Division of Infectious Diseases and Immunology at the Saint Louis University School of Medicine.

Jo Viney, Ph.D. is Vice President, Immunology Research, Biogen Idec., former president of the Society for Mucosal Immunology and founder of the journal Mucosal Immunology.

— 

7 Reasons to Further Examine
Vaxart, Inc. (NASDAQ:VXRT

  1. Vaxart is currently the ONLY US-based company to have publicly announced it is developing an oral vaccine for the Wuhan coronavirus (COVID-19)
  2. Among a very small handful of companies that publicly announced the initiation of a coronavirus vaccine before February of this year… getting out over a month ahead of most others in the race.
  3. Partnership in place with Emergent Biosolutions to develop and manufacture the oral vaccine in the USA, with Vaxart’s proprietary VAASTTM platform.
  4. Oral vaccines come with significant potential benefits, including safer, faster, and cheaper distribution to countries around the world.
  5. Stable room-temperature tablet form presents significant advantages in fight against coronavirus (COVID-19), especially in developing nations.
  6. Phase 1 clinical study expected in early second half of 2020
  7. Highly capable leadership team, with diverse experience backgrounds at major corporations including Merck, Novartis, and DOW.

Editorial Team
Biotech Insider


Sources:


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