Vaxart

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Vaxart, Inc.
Company typePublic
Nasdaq: VXRT
IndustryBiotechnology
Founded2004
FounderSean Tucker
HeadquartersSouth San Francisco, California
Key people
Steven Lo (CEO)
ProductsOral vaccines
RevenueIncrease US $7.38 million (2023)
Decrease US -$82.4 million (2023)
Number of employees
109 (2023)
Websitevaxart.com
Footnotes / references
[1]

Vaxart, Inc. is an American

human papillomavirus. It was founded in 2004 by Sean Tucker.[2] 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.[3]

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.[4]

Technology

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

intramuscular injection concerns which may involve pain, fear of needles, cross-contamination, dosing inconsistencies, and higher cost for large-scale immunizations.[5][6] As a proof of concept for oral vaccination efficacy, an oral vaccine against polio was proved to be safe and effective, and is in common use in many countries.[7][8][9]

Vaxart uses

mucosal immune responses against a virus.[10][11][6][12]

Vaxart uses a specific virus called

epithelial cells 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.[11][6][12]

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.[14]

Vaccine development

Influenza Vaccine

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

Fluzone.[11]

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, Inovio Pharmaceuticals, and Moderna.[17][13][18][11]

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

COVID-19.[17][13][18]

In April, the company reported positive immune responses in laboratory animals from its tests with a vaccine candidate for COVID-19.[19]

In January 2024, Vaxart received a grant from the United States Biomedical Advanced Research and Development Authority (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. [20]

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 Foundationfor 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.[21]

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.[22] 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. [23]

Additionally, in September 2023, Vaxart announced top-line data from its Phase 2 challenge study of the monovalent norovirus vaccine candidate. [24] 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 funds invested in Vaxart, with the largest investment coming from Armistice Capital which acquired 25.2 million shares.[25][26]

See also

References

  1. ^ {{Cite web|date=Dec 31, 2023|title=FORM 10-K|url=}
  2. ^ Leuty, Ron (August 6, 2013). "Flu vaccine developer Vaxart snags $20 million". www.bizjournals.com. Retrieved 2022-01-09.
  3. ^ "Vaxart Inc. Closes Merger with Aviragen Therapeutics, Inc". Business Wire. February 13, 2018. Retrieved January 29, 2024.
  4. ^ "Vaxart, Inc. 2023 10-K Filing". Vaxart, Inc. March 15, 2023. Retrieved January 29, 2024.
  5. PMID 29624470
    .
  6. ^
    PMID 2633331
    . Retrieved 27 January 2020.
  7. PMID 30376081
    .
  8. ^ "Polio Vaccination: What Everyone Should Know". National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention. May 4, 2018. Retrieved 5 March 2020.
  9. ^ "Polio: Global Eradication Initiative". Global Polio Eradication Initiative, World Health Organization. 2020. Retrieved 5 March 2020.
  10. ^ "Vaxart enters into research collaboration with Janssen to evaluate oral universal influenza vaccine: Oral vaccine candidate to be evaluated in pre-clinical challenge model". Business Wire. July 9, 2019. Retrieved 1 March 2020.
  11. ^ a b c d "Vaxart (VXRT) - A long shot or perfect shot?". NASDAQ, RTTNews.com. 25 February 2020. Retrieved 1 March 2020.
  12. ^
    S2CID 7058518
    . Retrieved 1 March 2020.
  13. ^ a b c Karen Carey (February 26, 2020). "Increasing number of biopharma drugs target COVID-19 as virus spreads". BioWorld. Retrieved 1 March 2020.
  14. ^ "Vaxart, Inc. 2023 10-K Filing". Vaxart, Inc. March 15, 2023. Retrieved January 29, 2024.
  15. PMID 26333337
    .
  16. S2CID 210892802
    .
  17. ^ a b "Vaxart (VXRT) to make vaccines to check coronavirus, stock up". Yahoo Finance. Zacks Equity Research. February 3, 2020. Retrieved 1 March 2020.
  18. ^ a b Gwen Everett (February 27, 2020). "These 5 drug developers have jumped this week on hopes they can provide a coronavirus treatment". Markets Insider. Retrieved 1 March 2020.
  19. ^ "Vaxart announces positive pre-clinical data for its oral COVID-19 vaccine program". Yahoo Finance. 2020-04-21. Retrieved 2020-04-21.
  20. ^ "Vaxart Receives $9.27 Million BARDA Project NextGen Award to Prepare for Phase 2b Clinical Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate". Vaxart, Inc. January 19, 2024. Retrieved January 29, 2024.
  21. ^ "Vaxart Announces Collaborative Funding from Leading Foundation to Study Its Norovirus Vaccine Candidate in Breastfeeding Mothers". GlobeNewswire. December 1, 2022. Retrieved January 29, 2024.
  22. ^ "Vaxart Doses First Subject in Phase 1 Trial of Its Norovirus Vaccine Candidate in Lactating Mothers". GlobeNewswire. November 2, 2023. Retrieved January 29, 2024.
  23. ^ "Vaxart Announces Positive Preliminary Topline Data from Dose-Ranging Phase 2 Study of its Bivalent Norovirus Vaccine Candidate". GlobeNewswire. July 6, 2023. Retrieved January 29, 2024.
  24. ^ "Vaxart Announces Topline Data from the Phase 2 Challenge Study of its Monovalent Norovirus Vaccine Candidate". GlobeNewswire. September 6, 2023. Retrieved January 29, 2024.
  25. ^ Debasis Saha (December 22, 2019). "Hedge funds have never been this bullish on Vaxart, Inc. (VXRT)". Hedge Fund News, Insider Monkey. Retrieved 1 March 2020.
  26. ^ "Vaxart - Top institutional holders". Yahoo Finance. 28 February 2020. Retrieved 1 March 2020.
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