Vaxart

Last updated
Vaxart, Inc.
Company type Public
Nasdaq:  VXRT
Industry Biotechnology
Founded2004
FounderSean Tucker
Headquarters South San Francisco, California
Key people
Steven Lo (CEO)
ProductsOral vaccines
RevenueIncrease2.svg US $7.38 million (2023)
Decrease2.svg US -$82.4 million (2023)
Number of employees
109 (2023)
Website vaxart.com
Footnotes /references
[1]

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] 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]

Contents

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 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. [10] [11] [6] [12]

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. [13] [6] [12] 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. [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 antibody responses to influenza virus in a 2015 Phase I clinical trial. [15] 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. [16] 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. [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

Related Research Articles

<span class="mw-page-title-main">Vaccine</span> Pathogen-derived preparation that provides acquired immunity to an infectious disease

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. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.

<span class="mw-page-title-main">H5N1 vaccine clinical trials</span> Clinical trials of influenza vaccine

H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.

GeoVax is a clinical-stage biotechnology company which develops vaccines. GeoVax's development platform uses Modified Vaccinia Ankara (MVA) vector technology, with improvements to antigen design and manufacturing capabilities. GeoVax uses recombinant DNA or recombinant viruses to produce virus-like particles (VLPs) in the person being vaccinated.

<span class="mw-page-title-main">Oxford Vaccine Group</span> Research group of the University of Oxford

The Oxford Vaccine Group (OVG) is a vaccine research group within the Department of Paediatrics at the University of Oxford. It was founded in 1994 by Professor E. Richard Moxon, was initially based at the John Radcliffe Hospital, and moved in 2003 to its current location in the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) at the Churchill Hospital in Oxford, England. The group, led by Professor Andrew Pollard since 2001, comprises around 75 members across a number of disciplines, including consultants in paediatrics and vaccinology, clinical research fellows, research nurses, statisticians, post-doctoral laboratory scientists, research assistants and DPhil students.

<span class="mw-page-title-main">Novavax</span> American biotechnology company

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 syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.

<span class="mw-page-title-main">Universal flu vaccine</span> Vaccine that prevents infection from all strains of the flu

A universal flu vaccine is a flu vaccine that is effective against all influenza strains regardless of the virus sub type, antigenic drift or antigenic shift. Hence it should not require modification from year to year. As of 2021 no universal flu vaccine had been approved for general use, several were in development, and one was in clinical trial.

Vaccine shedding is a form of viral shedding which can occasionally occur following a viral infection caused by an attenuated vaccine. Illness in others resulting from transmission through this type of viral shedding is rare. Most vaccines are not attenuated vaccines, and therefore cannot cause vaccine-induced viral shedding, though the idea of shedding is a popular anti-vaccination myth.

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, academic centers, or research organizations developing a vaccine candidate for treating people infected with COVID-19, with more than 170 total vaccine candidates in development.

A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.

<span class="mw-page-title-main">COVID-19 vaccine</span> Vaccine against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).

Helen Y. Chu is an American immunologist who is an assistant professor of medicine at the University of Washington. Her research considers maternal immunization, with a focus on influenza and respiratory syncytial virus. During the COVID-19 pandemic, Chu was the first physician to recognise community transmission of the coronavirus disease within the United States.

<span class="mw-page-title-main">Medicago Inc.</span> Canadian biotechnology company

Medicago Inc. was a Canadian biotechnology company focused on the discovery, development, and commercialization of virus-like particles using plants as bioreactors to produce proteins, candidate vaccines, and medications. By using live plant leaves as hosts in the discovery and manufacturing process, the Medicago "Proficia" technology intended to create a rapid, high-yield system for its product candidates. Privately owned by a subsidiary of Mitsubishi Tanabe Pharma, Medicago and its product development programs were terminated by Mitsubishi in February 2023.

A nasal vaccine is a vaccine administered through the nose that stimulates an immune response without an injection. It induces immunity through the inner surface of the nose, a surface that naturally comes in contact with many airborne microbes. Nasal vaccines are emerging as an alternative to injectable vaccines because they do not use needles and can be introduced through the mucosal route. Nasal vaccines can be delivered through nasal sprays to prevent respiratory infections, such as influenza.

<span class="mw-page-title-main">Covaxin</span> Vaccine against COVID-19

Covaxin is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Vaccine candidate against COVID-19

The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

<span class="mw-page-title-main">UB-612</span> Vaccine candidate against COVID-19

UB-612 is a COVID-19 vaccine candidate developed by United Biomedical Asia, and Vaxxinity, Inc. It is a peptide vaccine.

<span class="mw-page-title-main">Viral vector vaccine</span> Type of vaccine

A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material (DNA) that can be transcribed by the recipient's host cells as mRNA coding for a desired protein, or antigen, to elicit an immune response. As of April 2021, six viral vector vaccines, four COVID-19 vaccines and two Ebola vaccines, have been authorized for use in humans.

<span class="mw-page-title-main">Vaxart COVID-19 vaccine</span> Vaccine candidate against COVID-19

Vaxart COVID-19 vaccine is a COVID-19 vaccine candidate developed by Vaxart.

Live recombinant vaccines are biological preparations that stimulate immune responses to a pathogen through the use of genetically modified live bacteria or viruses. These live pathogens are biologically engineered to express exogenous antigens in the cytoplasm of target cells, thereby triggering immune responses. This form of vaccine combines the beneficial features of attenuated and recombinant vaccines, providing the long-lasting immunity of attenuated vaccines’ with recombinant vaccines’ genetically engineered precision and safety.

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. ↑ 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. 1 2 3 4 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. ↑ "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. 1 2 3 4 "Vaxart (VXRT) - A long shot or perfect shot?". NASDAQ, RTTNews.com. 25 February 2020. Retrieved 1 March 2020.
  12. 1 2 3 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.
  13. 1 2 3 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. ↑ 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. 15 (9). Elsevier BV: 1041–1048. doi:10.1016/s1473-3099(15)00266-2. ISSN   1473-3099. PMID   26333337.
  16. ↑ 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.
  17. 1 2 "Vaxart (VXRT) to make vaccines to check coronavirus, stock up". Yahoo Finance. Zacks Equity Research. February 3, 2020. Retrieved 1 March 2020.
  18. 1 2 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.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.