Novavax

Novavax, Inc. is an American vaccine development company headquartered in Gaithersburg, Maryland, with additional facilities in Rockville, Maryland and Uppsala, Sweden. As of 2020, it had an ongoing Phase III clinical trial in older adults for its candidate vaccine for seasonal influenza, NanoFlu and a candidate vaccine (NVX-CoV2373) for prevention of COVID-19.

Novavax, Inc.
TypePublic
NASDAQ: NVAX
Russell 2000 Component
IndustryBiotechnology
Founded1987 (1987) [1]
Headquarters
Gaithersburg, Maryland
,
United States
Area served
Worldwide
Key people
Stanley Erck (CEO)
ProductsVaccines
Number of employees
~375[2]
Websitewww.novavax.com

History

Novavax was founded in 1987. It focused principally on experimental vaccine development, but did not achieve a successful launch up to 2021.[3]

In June 2013, Novavax acquired the Matrix-M adjuvant platform with the purchase of Swedish company Isconova AB and renamed its new subsidiary Novavax AB.[4]

In 2015, the company received an $89 million grant from the Bill & Melinda Gates Foundation to support the development of a vaccine against human respiratory syncytial virus for infants via maternal immunization.[5][6][7][8]

In March 2015 the company completed a Phase I trial for its Ebola vaccine candidate,[9] as well as a phase II study in adults for its RSV vaccine, which would become ResVax.[10] The ResVax trial was encouraging as it showed significant efficacy against RSV infection.[10]

2016 saw the company's first phase III trial, the 12,000 adult Resolve trial,[10] for its respiratory syncytial virus vaccine, which would come to be known as ResVax, fail in September.[2] This triggered an eighty-five percent dive in the company's stock price.[2] Phase II adult trial results also released in 2016 showed a stimulation of antigencity, but failure in efficacy.[10] Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials.[2] The company's difficulties in 2016 led to a three part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a Zika virus vaccine.[2]

Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.[10]

In 2019, late-stage clinical testing of ResVax, failed for a second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm.[11][12] As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted.[12]

The company positions NanoFlu for the unmet need for a more effective vaccine against influenza, particularly in the elderly who often experience serious and sometimes life-threatening complications. In January 2020, it was granted fast track status by the U.S. Food and Drug Administration (FDA) for NanoFlu.

External sponsorships

In 2018, Novavax received a US$89 million research grant from the Bill and Melinda Gates Foundation for development of vaccines for maternal immunization.[13]

In May 2020, Novavax received US$384 million from the Coalition for Epidemic Preparedness Innovations to fund early-stage evaluation in healthy adults of the company's COVID-19 vaccine candidate NVX-CoV2373 and to develop resources in preparation for large-scale manufacturing, if the vaccine proves successful.[14] CEPI had already invested $4 million in March.[14]

Drugs in development

ResVax is a nanoparticle-based treatment using a recombinant F lipoprotein or saponin, "extracted from the Quillaja saponaria [or?] Molina bark together with cholesterol and phospholipid."[15] It is aimed at stimulating resistance to respiratory syncytial virus infection, targeting both adult and infant populations.[10]

In January 2020, Novavax was given Fast Track status by the FDA to expedite the review process for NanoFlu, a candidate influenze vaccine undergoing a Phase III clinical trial scheduled for completion by mid-2020.[16]

COVID-19 vaccine candidate
See also: NVX-CoV2373 and COVID-19 vaccine

In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2.[17] NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus.[18] Novavax's work is in competition for vaccine development among dozens of other companies.

In January 2021, the company released phase 3 trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants.[19] It has applied for emergency use in the US and UK.

See also

References
  1. "Company Overview of Novavax, Inc". Bloomberg.com. Archived from the original on 24 February 2017. Retrieved 2 June 2019.
  2. Bell, Jacob (November 14, 2016). "Novavax aims to rebound with restructuring, more trials". BioPharma Dive. Washington, D.C.: Industry Dive. Archived from the original on 2017-03-29. Retrieved 2017-03-28.
  3. Thomas, Katie; Twohey, Megan (2020-07-16). "How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine". The New York Times. ISSN 0362-4331. Retrieved 2021-01-29.
  4. Taylor, Nick Paul (3 June 2013). "Novavax makes $30M bid for adjuvant business". FiercePharma. Archived from the original on 14 September 2016. Retrieved 9 September 2016.
  5. "Gaithersburg Biotech Receives Grant Worth up to $89 million". Bizjournals.com. Archived from the original on 2017-04-01. Retrieved 2017-03-28.
  6. "With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII | FierceBiotech". Fiercebiotech.com. Archived from the original on 2017-04-14. Retrieved 2017-03-28.
  7. "Novavax RSV vaccine found safe for pregnant women, fetus". Reuters. 2016-09-29. Archived from the original on 2016-10-07. Retrieved 2017-03-28.
  8. Herper, Matthew. "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Archived from the original on 2016-09-21. Retrieved 2017-03-28.
  9. "Novavax's Ebola vaccine shows promise in early-stage trial". Reuters. 2017-07-21. Archived from the original on 2016-10-02. Retrieved 2017-03-28.
  10. Adams, Ben (September 16, 2016). "Novavax craters after Phase III RSV F vaccine failure; seeks path forward". FierceBiotech. Questex. Archived from the original on 18 August 2020. Retrieved 25 Jan 2020.
  11. Shtrubel, Marty (December 12, 2019). "3 Biotech Stocks That Offer the Highest Upside on Wall Street". Biotech. Nasdaq. Archived from the original on 2020-01-26. Retrieved 25 Jan 2020.
  12. Budwell, George (January 20, 2020). "3 Top Biotech Picks for 2020". Markets. Nasdaq. Novavax: A catalyst awaits. Archived from the original on 2020-01-25. Retrieved 25 Jan 2020.
  13. Mark Terry (February 16, 2018). "Why Novavax Could be a Millionaire-Maker Stock". BioSpace. Archived from the original on 22 November 2020. Retrieved 6 March 2020.
  14. Eric Sagonowsky (2020-05-11). "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work". FiercePharma. Archived from the original on 2020-05-16. Retrieved 2020-05-12.
  15. "Novavax addresses urgent global public health needs with innovative technology". novavax.com. Archived from the original on 10 September 2020. Retrieved 30 August 2020.
  16. Sara Gilgore (January 15, 2020). "Novavax earns key FDA status for its flu vaccine. Wall Street took it well". Washington Business Journal. Archived from the original on 10 November 2020. Retrieved 6 March 2020.
  17. Sara Gilgore (February 26, 2020). "Novavax is working to advance a potential coronavirus vaccine. So are competitors". Washington Business Journal. Archived from the original on March 16, 2020. Retrieved March 6, 2020.
  18. Nidhi Parekh (July 24, 2020). "Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19". Archived from the original on November 22, 2020. Retrieved July 24, 2020.
  19. "Covid-19: Novavax vaccine shows 89% efficacy in UK trials". BBC news. Retrieved 1 February 2021.

Further reading
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