Vaxart, Inc. is an American

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

company focused on the discovery, development, and commercialization of oral

recombinant vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.

s administered using temperature-stable tablets that can be stored and shipped without refrigeration, eliminating the need for needle injection. Its development programs for oral vaccine delivery (Vector-Adjuvant-Antigen Standardized Technology known as ''VAAST'') include

prophylactic Preventive healthcare, or prophylaxis, consists of measures taken for the purposes of disease prevention.Hugh R. Leavell and E. Gurney Clark as "the science and art of preventing disease, prolonging life, and promoting physical and mental hea ...

, enteric-coated tablet vaccines for inhibiting

norovirus Norovirus, sometimes referred to as the winter vomiting disease, is the most common cause of gastroenteritis. Infection is characterized by non-bloody diarrhea, vomiting, and stomach pain. Fever or headaches may also occur. Symptoms usually deve ...

seasonal influenza Flu season is an annually recurring time period characterized by the prevalence of an outbreak of influenza (flu). The season occurs during the cold half of the year in each hemisphere. It takes approximately two days to show symptoms. Influen ...

respiratory syncytial virus Respiratory syncytial virus (RSV), also called human respiratory syncytial virus (hRSV) and human orthopneumovirus, is a common, contagious virus that causes infections of the respiratory tract. It is a negative-sense, single-stranded RNA virus. ...

, and

human papillomavirus Human papillomavirus infection (HPV infection) is caused by a DNA virus from the ''Papillomaviridae'' family. Many HPV infections cause no symptoms and 90% resolve spontaneously within two years. In some cases, an HPV infection persists and res ...

. It was founded in 2004 by Sean Tucker. Originally incorporated as West Coast Biologicals, Inc. in California in 2004, the company later changed its name to Vaxart, Inc. in July 2007, after reincorporating in Delaware. A significant development in the company's history was the reverse merger with Aviragen Therapeutics, Inc. on February 13, 2018, which led to Vaxart becoming a wholly-owned subsidiary of Aviragen. Post-merger, the company continued as Vaxart, Inc. Vaxart's development portfolio includes a range of oral vaccines targeting infectious diseases such as norovirus, COVID-19, and seasonal influenza, as well as therapeutic vaccines like those targeting HPV. The company has achieved significant milestones in its vaccine development, including completing Phase 1 trials for its COVID-19 vaccine candidate and embarking on Phase 2 studies. Vaxart’s vaccines are designed to elicit not only systemic immune responses but also mucosal and T cell responses, which may enhance protection against specific diseases and offer potential benefits for certain cancers and chronic viral infections. The tablet form of these vaccines represents a significant advancement in vaccine administration, potentially improving patient acceptance and resolving distribution challenges.

Technology

The Vaxart technology is based on the potential to prevent or inhibit

infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...

s by using orally-delivered vaccines by tablets, eliminating

intramuscular Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have l ...

injection concerns which may involve pain,

fear of needles Fear of needles, known in medical literature as needle phobia, is the extreme fear of medical procedures involving injections or hypodermic needles. This can lead to avoidance of medical care, including vaccine hesitancy. It is occasionally refe ...

, cross-contamination, dosing inconsistencies, and higher cost for large-scale

immunization Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an infectious agent (known as the immunogen). When this system is exposed to molecules that are foreign to the body, called ''non-sel ...

s.{{cite journal , last1=Zheng , first1=Zhichao , last2=Diaz-Arévalo , first2=Diana , last3=Guan , first3=Hongbing , last4=Zeng , first4=Mingtao , title=Noninvasive vaccination against infectious diseases (Review), journal=Human Vaccines & Immunotherapeutics, volume=14 , issue=7 , date=17 May 2018 , issn=2164-5515 , pmid=29624470 , pmc=6067898 , doi=10.1080/21645515.2018.1461296 , pages=1717–1733{{cite journal, url=https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00252-2/fulltext#seccestitle10, title=An influenza vaccine pill - can we swallow it?, pmid=2633331, doi=10.1016/s1473-3099(15)00252-2, journal=The Lancet Infectious Diseases, date=1 September 2015, access-date=27 January 2020, volume=15, issue=9, last1=Fast, first1=Patricia E, last2=Cox, first2=Josephine H, pages=1051–6; discussion 1056–7 As a

proof of concept Proof of concept (POC or PoC), also known as proof of principle, is a realization of a certain method or idea in order to demonstrate its feasibility, or a demonstration in principle with the aim of verifying that some concept or theory has prac ...

for oral vaccination efficacy, an oral vaccine against

polio Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 70% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe s ...

was proved to be safe and effective, and is in common use in many countries.{{cite journal , last1=Bandyopadhyay , first1=Ananda S , last2=Modlin , first2=John F , last3=Wenger , first3=Jay , last4=Gast , first4=Chris , title=Immunogenicity of New Primary Immunization Schedules With Inactivated Poliovirus Vaccine and Bivalent Oral Polio Vaccine for the Polio Endgame: A Review , journal=Clinical Infectious Diseases, volume=67 , issue=suppl_1 , date=30 October 2018 , issn=1058-4838 , pmid=30376081 , pmc=6206125 , doi=10.1093/cid/ciy633 , pages=S35–S41{{cite web , title=Polio Vaccination: What Everyone Should Know , url=https://www.cdc.gov/vaccines/vpd/polio/public/index.html , publisher=National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention , access-date=5 March 2020 , date=May 4, 2018{{cite web , title=Polio: Global Eradication Initiative , url=http://polioeradication.org/polio-today/faq/ , publisher=Global Polio Eradication Initiative, World Health Organization , access-date=5 March 2020 , date=2020 Vaxart uses enteric-coated tablets to protect the active vaccine from acidic degradation in the stomach, delivering the vaccine into the

small intestine The small intestine or small bowel is an organ in the gastrointestinal tract where most of the absorption of nutrients from food takes place. It lies between the stomach and large intestine, and receives bile and pancreatic juice through the p ...

where it can engage the

immune system The immune system is a network of biological processes that protects an organism from diseases. It detects and responds to a wide variety of pathogens, from viruses to parasitic worms, as well as cancer cells and objects such as wood splinte ...

to stimulate

systemic Systemic fundamental to a predominant social, economic, or political practice. This refers to: In medicine In medicine, ''systemic'' means affecting the whole body, or at least multiple organ systems. It is in contrast with ''topical'' or ''loc ...

and

mucosa A mucous membrane or mucosa is a membrane that lines various cavities in the body of an organism and covers the surface of internal organs. It consists of one or more layers of epithelial cells overlying a layer of loose connective tissue. It is ...

immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could ...

s against a virus.{{cite web , title=Vaxart enters into research collaboration with Janssen to evaluate oral universal influenza vaccine: Oral vaccine candidate to be evaluated in pre-clinical challenge model , url=https://www.businesswire.com/news/home/20190709005100/en/Vaxart-Enters-Research-Collaboration-Janssen-Evaluate-Oral , publisher=Business Wire , access-date=1 March 2020 , date=July 9, 2019{{cite web , title=Vaxart (VXRT) - A long shot or perfect shot? , url=https://www.nasdaq.com/articles/vaxart-vxrt-a-long-shot-or-perfect-shot-2020-02-25 , publisher=NASDAQ, RTTNews.com , access-date=1 March 2020 , date=25 February 2020{{cite journal , author1=SN Tucker , author2=DW Tingley , author3=CD Scallan , title=Oral adenovirus-based vaccines: historical perspective and future opportunity , journal= Expert Review of Vaccines, volume=7, issue=1 , year=2008 , pages=25–31 , url=https://www.researchgate.net/publication/5599995 , access-date=1 March 2020, issn=1476-0584, doi=10.1586/14760584.7.1.25, pmid=18251691 , s2cid=7058518 Vaxart uses a specific virus called

adenovirus Adenoviruses (members of the family ''Adenoviridae'') are medium-sized (90–100 nm), nonenveloped (without an outer lipid bilayer) viruses with an icosahedral nucleocapsid containing a double-stranded DNA genome. Their name derives from the ...

type 5 (Ad5) as a delivery biological "vector" to carry

gene In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a ba ...

s coding for the

antigen In immunology, an antigen (Ag) is a molecule or molecular structure or any foreign particulate matter or a pollen grain that can bind to a specific antibody or T-cell receptor. The presence of antigens in the body may trigger an immune response. ...

to generate a protective immune response. The Ad5 vector delivers the antigen to the

epithelial cell Epithelium or epithelial tissue is one of the four basic types of animal tissue, along with connective tissue, muscle tissue and nervous tissue. It is a thin, continuous, protective layer of compactly packed cells with a little intercellula ...

s lining the mucosa of the small intestine where it stimulates the immune system to respond against the vaccine antigen, creating a systemic immune response against a virus. In addition to its focus on infectious diseases, Vaxart has expanded its vaccine development efforts to include therapeutic vaccines for chronic viral infections and cancer. These efforts are anchored in the company's innovative technology that enables the creation of tablet-based vaccines, which can generate broad and durable immune responses, including systemic, mucosal, and T-cell responses. This comprehensive immune activation is particularly critical in the context of chronic viral infections and cancer, where both systemic and localized immune responses play a pivotal role in effective treatment.

Vaccine development

Influenza Vaccine

The lead vaccine candidate by Vaxart is an influenza oral tablet vaccine, which showed safety and neutralizing

antibody An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of the ...

responses to influenza virus in a 2015

Phase I clinical trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

.{{cite journal , last1=Liebowitz , first1=David , last2=Lindbloom , first2=Jonathan D , last3=Brandl , first3=Jennifer R , last4=Garg , first4=Shaily J , last5=Tucker , first5=Sean N , title=High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial , journal=The Lancet Infectious Diseases , publisher=Elsevier BV , volume=15 , issue=9 , year=2015 , issn=1473-3099 , doi=10.1016/s1473-3099(15)00266-2 , pages=1041–1048, pmid=26333337 , url=https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00266-2/fulltext A 2016-17

Phase II trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

of the Vaxart oral flu vaccine, VXA-A1.1, showed that the vaccine was well-tolerated and provided immunity against virus shedding, outperforming the effectiveness of an established intramuscular vaccine.{{cite journal , last1=Liebowitz , first1=David , last2=Gottlieb , first2=Keith , last3=Kolhatkar , first3=Nikita S , last4=Garg , first4=Shaily J , last5=Asher , first5=Jason M , last6=Nazareno , first6=Jonathan , last7=Kim , first7=Kenneth , last8=McIlwain , first8=David R , last9=Tucker , first9=Sean N , title=Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study , journal=The Lancet Infectious Diseases, year=2020 , volume=20 , issue=4 , pages=435–444 , issn=1473-3099 , doi=10.1016/s1473-3099(19)30584-5, pmid=31978354 , s2cid=210892802 , url=https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(19)30584-5/fulltext In 2018, Vaxart completed a Phase II challenge study, in which the Vaxart influenza tablet vaccine demonstrated a 39 percent reduction in clinical disease relative to placebo, compared to a 27 percent reduction by the injectable flu vaccine,

Fluzone Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fro ...

COVID-19 vaccine

In January 2020, Vaxart announced development of a tablet vaccine to inhibit COVID-19. Some of its competitors were companies such as

Novavax Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory sy ...

Inovio Pharmaceuticals Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among some 100 companies, a ...

, and

Moderna Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to produ ...

. In February 2020, Vaxart began a program to develop an oral tablet vaccine for

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...

.{{cite news , title=Vaxart (VXRT) to make vaccines to check coronavirus, stock up , url=https://finance.yahoo.com/news/vaxart-vxrt-vaccines-check-coronavirus-161604338.html , access-date=1 March 2020 , work=Yahoo Finance , publisher=Zacks Equity Research , date=February 3, 2020{{cite web , author1=Karen Carey , title=Increasing number of biopharma drugs target COVID-19 as virus spreads , url=https://www.bioworld.com/articles/433331-increasing-number-of-biopharma-drugs-target-covid-19-as-virus-spreads , publisher=BioWorld , access-date=1 March 2020 , date=February 26, 2020{{cite web , author1=Gwen Everett , title=These 5 drug developers have jumped this week on hopes they can provide a coronavirus treatment , url=https://markets.businessinsider.com/news/stocks/drug-stocks-gain-companies-coronavirus-vaccine-potential-wall-street-buys-2020-2-1028947495 , publisher=Markets Insider , access-date=1 March 2020 , date=February 27, 2020 In April, the company reported positive immune responses in laboratory animals from its tests with a vaccine candidate for COVID-19. In January 2024, Vaxart received a grant from the United States

Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, in ...

(BARDA). The grant, amounting to $9.27 million, is allocated for the preparation of a large-scale Phase 2b clinical trial involving 10,000 participants. This trial is designed to evaluate the efficacy of Vaxart's innovative oral pill XBB COVID-19 vaccine candidate in comparison to an approved mRNA vaccine. The funding is part of Project NextGen, a substantial $5 billion initiative by the U.S. Department of Health and Human Services (HHS) focusing on the development of new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19. The oral vaccine platform developed by Vaxart is noted for its potential advantages, including generating mucosal immunity and offering a cross-reactive response to various COVID-19 variants.

Norovirus vaccine

Vaxart has been progressing in the development of an oral tablet vaccine for Norovirus, the leading cause of acute gastroenteritis globally. Norovirus significantly impacts all age groups, particularly young children and the elderly, causing millions of cases annually with substantial healthcare and economic burdens. Its vaccine candidate is a bivalent oral tablet targeting major norovirus genogroups GI and GII. The tablet form is specifically crafted to generate antibodies in the intestine, the primary site of norovirus infection. In December 2022, Vaxart received significant funding and support from the

Bill & Melinda Gates Foundation The Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was l ...

for a study focusing on breastfeeding mothers and their infants. This study aligns with Vaxart’s broader norovirus vaccine program goals, targeting critical and at-risk populations globally. In 2023, Vaxart initiated a Phase 1 trial (VXA-NVV-108) focused on lactating mothers, aiming to evaluate the vaccine's ability to induce breast milk antibodies and their transfer to infants. Furthermore, in July 2023, Vaxart announced positive topline data from a dose-ranging Phase 2 clinical trial of its bivalent norovirus vaccine candidate. The study met all primary endpoints, showing the vaccine was well-tolerated with robust immunogenicity. Additionally, in September 2023, Vaxart announced top-line data from its Phase 2 challenge study of the monovalent norovirus vaccine candidate. This study met 5 of its 6 primary endpoints, demonstrating a statistically significant reduction in norovirus infection rate and a substantial reduction in viral shedding, while maintaining a well-tolerated safety profile.

Investment

In 2019, several

hedge fund A hedge fund is a pooled investment fund that trades in relatively liquid assets and is able to make extensive use of more complex trading, portfolio-construction, and risk management techniques in an attempt to improve performance, such as sho ...

s invested in Vaxart, with the largest investment coming from Armistice Capital which acquired 25.2 million shares.{{cite web , author1=Debasis Saha , title=Hedge funds have never been this bullish on Vaxart, Inc. (VXRT) , url=https://www.insidermonkey.com/blog/hedge-funds-have-never-been-this-bullish-on-vaxart-inc-vxrt-812685/ , publisher=Hedge Fund News, Insider Monkey , access-date=1 March 2020 , date=December 22, 2019{{cite web , title=Vaxart - Top institutional holders , url=https://finance.yahoo.com/quote/VXRT/holders?p=VXRT , publisher=Yahoo Finance , access-date=1 March 2020 , date=28 February 2020

References

{{Reflist Companies listed on the Nasdaq Companies based in San Francisco Biotechnology companies of the United States Pharmaceutical companies established in 1982 Life sciences industry Specialty drugs Biotechnology companies established in 1982 Vaccine producers COVID-19 vaccine producers Medical research