Vaxart

Vaxart, Inc. is an American biotechnology company focused on the discovery, development, and commercialization of oral recombinant vaccines 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, enteric-coated tablet vaccines for inhibiting norovirus, seasonal influenza, respiratory syncytial virus, and human papillomavirus. It was founded in 2004 by Sean Tucker.[2]

Vaxart, Inc.
TypePublic
Nasdaq: VXRT
IndustryBiotechnology
Founded2004
FounderSean Tucker
HeadquartersSouth San Francisco, California
Key people
Andrei "Andy" Floroiu (CEO)
ProductsOral vaccines
RevenueDecrease US$892,000 (2021)
Decrease –US$70.5 million (2021)
Number of employees
110 (2021)
Websitevaxart.com
Footnotes / references
[1]

Vaxart has a collaborative development program for oral delivery of a vaccine against universal flu using proprietary antigens from Janssen Pharmaceutica (Janssen Vaccines and Prevention B.V.).[3][4]

Technology

The Vaxart technology is based on the potential to prevent or inhibit infectious diseases by using orally-delivered vaccines by tablets, eliminating 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 enteric-coated tablets to protect the active vaccine from acidic degradation in the stomach, delivering the vaccine into the small intestine where it can engage the immune system to stimulate systemic and mucosal immune responses against a virus.[3][4][6][10]

Vaxart uses a specific virus called adenovirus type 5 (Ad5) as a delivery biological "vector" to carry genes coding for the antigen to generate a protective immune response.[11][6][10] The Ad5 vector delivers the antigen to the 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.[4][6][10]

Vaccine development
Main article: Vaxart COVID-19 vaccine

The lead vaccine candidate by Vaxart is an influenza oral tablet vaccine, which showed safety and neutralizing antibody responses to influenza virus in a 2015 Phase I clinical trial.[12] A 2016-17 Phase II trial 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.[13] 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.[4]

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.[14][11][15][4]

In February 2020, Vaxart began a program to develop an oral tablet vaccine for COVID-19.[14][11][15]

In April, the company reported positive immune responses in laboratory animals from its tests with a vaccine candidate for COVID-19.[16]

In October 2020, Vaxart was under investigation by the SEC and federal prosecutors after the company may have exaggerated its role in and investment from Operation Warp Speed.[17] Vaxart settled the investor lawsuit for $12 million in July 2022.[18]

Investment

In 2019, several hedge funds invested in Vaxart, with the largest investment coming from Armistice Capital which acquired 25.2 million shares.[19][20]

See also

References
  1. "FORM 10-K". Vaxart. Dec 31, 2021. pp. 48, 103.
  2. Leuty, Ron (August 6, 2013). "Flu vaccine developer Vaxart snags $20 million". www.bizjournals.com. Retrieved 2022-01-09.
  3. "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.
  4. "Vaxart (VXRT) - A long shot or perfect shot?". NASDAQ, RTTNews.com. 25 February 2020. Retrieved 1 March 2020.
  5. Zheng, Zhichao; Diaz-Arévalo, Diana; Guan, Hongbing; Zeng, Mingtao (17 May 2018). "Noninvasive vaccination against infectious diseases (Review)". Human Vaccines & Immunotherapeutics. 14 (7): 1717–1733. doi:10.1080/21645515.2018.1461296. ISSN 2164-5515. PMC 6067898. PMID 29624470.
  6. Fast, Patricia E; Cox, Josephine H (1 September 2015). "An influenza vaccine pill - can we swallow it?". The Lancet Infectious Diseases. 15 (9): 1051–6, discussion 1056–7. doi:10.1016/s1473-3099(15)00252-2. PMID 2633331. Retrieved 27 January 2020.
  7. Bandyopadhyay, Ananda S; Modlin, John F; Wenger, Jay; Gast, Chris (30 October 2018). "Immunogenicity of New Primary Immunization Schedules With Inactivated Poliovirus Vaccine and Bivalent Oral Polio Vaccine for the Polio Endgame: A Review". Clinical Infectious Diseases. 67 (suppl_1): S35–S41. doi:10.1093/cid/ciy633. ISSN 1058-4838. PMC 6206125. 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. SN Tucker; DW Tingley; CD Scallan (2008). "Oral adenovirus-based vaccines: historical perspective and future opportunity". Expert Review of Vaccines. 7 (1): 25–31. doi:10.1586/14760584.7.1.25. ISSN 1476-0584. PMID 18251691. S2CID 7058518. Retrieved 1 March 2020.
  11. Karen Carey (February 26, 2020). "Increasing number of biopharma drugs target COVID-19 as virus spreads". BioWorld. Retrieved 1 March 2020.
  12. Liebowitz, David; Lindbloom, Jonathan D; Brandl, Jennifer R; Garg, Shaily J; Tucker, Sean N (2015). "High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial". The Lancet Infectious Diseases. Elsevier BV. 15 (9): 1041–1048. doi:10.1016/s1473-3099(15)00266-2. ISSN 1473-3099. PMID 26333337.
  13. Liebowitz, David; Gottlieb, Keith; Kolhatkar, Nikita S; Garg, Shaily J; Asher, Jason M; Nazareno, Jonathan; Kim, Kenneth; McIlwain, David R; Tucker, Sean N (2020). "Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study". The Lancet Infectious Diseases. 20 (4): 435–444. doi:10.1016/s1473-3099(19)30584-5. ISSN 1473-3099. PMID 31978354. S2CID 210892802.
  14. "Vaxart (VXRT) to make vaccines to check coronavirus, stock up". Yahoo Finance. Zacks Equity Research. February 3, 2020. Retrieved 1 March 2020.
  15. 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.
  16. "Vaxart announces positive pre-clinical data for its oral COVID-19 vaccine program". Yahoo Finance. 2020-04-21. Retrieved 2020-04-21.
  17. "Vaccine company Vaxart faces federal investigation for allegedly exaggerating role in Operation Warp Speed". ABC News. 17 October 2020. Retrieved 17 October 2020.
  18. "Tablet Covid vaccine hopeful settles suit claiming it overhyped its prospects for success". bizjournals.com. 2022-07-29.
  19. 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.
  20. "Vaxart - Top institutional holders". Yahoo Finance. 28 February 2020. Retrieved 1 March 2020.
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