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 has an ongoing Phase III clinical trial in older adults for its candidate vaccine for seasonal influenza, NanoFlu and a candidate vaccine for prevention of COVID-19.

Novavax, Inc.
Public
Traded asNASDAQ: NVAX
Russell 2000 Component
IndustryBiotechnology
Founded1987 (1987) [1]
Headquarters
Gaithersburg, Maryland
,
U.S.
Area served
Worldwide
ProductsVaccines
Number of employees
~375[2]
WebsiteNovavax.com

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. In July 2020, Novavax received $1.6 billion to fast track a coronavirus vaccine by the beginning of 2021.[3]

History

In June 2013, Novavax acquired the Matrix-MTM adjuvant platform with the purchase of Swedish company Isconova AB and renamed it 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 firing 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]

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, aimed at stimulating resistance to respiratory syncitial virus infection, targeting both adult and infant populations.[10] In January 2020, Novovax 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.[15]

COVID-19 vaccine candidate
See also: COVID-19 vaccine § Clinical trials started in 2020

In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2.[16]. NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 molecule[17]. Novavax's work is in competition for vaccine development among dozens of other companies.[18] In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[19] Under the partnership, Emergent BioSolutions will manufacture the vaccine at large-scale at their Baltimore facility.[20] The first human safety studies of the candidate, named NVX-CoV2373, started in May 2020 in Australia.[14][21] In July, the company announced it might receive $1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 —if clinical trials show the vaccine to be effective.[3] A spokesperson for Novavax stated that the $1.6 billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense,[3] where Gen. Gustave F. Perna has been selected as COO for Warp Speed.

See also

References
  1. "Bloomberg - Are you a robot?". Bloomberg.com. 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. Retrieved 2017-03-28.
  3. Katie Thomas (2020-07-07). "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine". The New York Times. Retrieved 2020-07-07.
  4. Taylor, Nick Paul (3 June 2013). "Novavax makes $30M bid for adjuvant business". FiercePharma. Retrieved 9 September 2016.
  5. "Gaithersburg Biotech Receives Grant Worth up to $89 million". Bizjournals.com. Retrieved 2017-03-28.
  6. "With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII | FierceBiotech". Fiercebiotech.com. Retrieved 2017-03-28.
  7. "Novavax RSV vaccine found safe for pregnant women, fetus". Reuters. 2016-09-29. Retrieved 2017-03-28.
  8. Herper, Matthew. "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Retrieved 2017-03-28.
  9. "Novavax's Ebola vaccine shows promise in early-stage trial". Reuters. 2017-07-21. Retrieved 2017-03-28.
  10. Adams, Ben (September 16, 2016). "Novavax craters after Phase III RSV F vaccine failure; seeks path forward". FierceBiotech. Questex. Retrieved 25 Jan 2020.
  11. Shtrubel, Marty (December 12, 2019). "3 Biotech Stocks That Offer the Highest Upside on Wall Street". Biotech. Nasdaq. Retrieved 25 Jan 2020.
  12. Budwell, George (January 20, 2020). "3 Top Biotech Picks for 2020". Markets. Nasdaq. Novavax: A catalyst awaits. Retrieved 25 Jan 2020.
  13. Mark Terry (February 16, 2018). "Why Novavax Could be a Millionaire-Maker Stock". BioSpace. Retrieved 6 March 2020.
  14. Eric Sagonowsky (2020-05-11). "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work". FiercePharma. Retrieved 2020-05-12.
  15. Sara Gilgore (January 15, 2020). "Novavax earns key FDA status for its flu vaccine. Wall Street took it well". Washington Business Journal. Retrieved 6 March 2020.
  16. Sara Gilgore (February 26, 2020). "Novavax is working to advance a potential coronavirus vaccine. So are competitors". Washington Business Journal. Retrieved March 6, 2020.
  17. Nidhi Parekh (July 24, 2020). "Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19". Retrieved July 24, 2020.
  18. "COVID-19 vaccine tracker (click on 'Vaccines' tab)". Milken Institute. 11 May 2020. Retrieved 12 May 2020. Lay summary.
  19. Gilgore, Sara (March 10, 2020). "Novavax's coronavirus vaccine program is getting some help from Emergent BioSolutions". Washington Business Journal. Retrieved March 10, 2020.
  20. "Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine". Washington Post. Retrieved 2020-05-08.
  21. "Novavax starts clinical trial of its coronavirus vaccine candidate". CNBC. 2020-05-25. Retrieved 2020-05-26.

Further reading
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