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Novavax

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Novavax, Inc.
Company typePublic
Nasdaq: NVAX
S&P 500 Component
IndustryBiotechnology
Founded1987 (1987)
Headquarters
Gaithersburg, Maryland
,
United States
Area served
Worldwide
ProductsVaccines
Revenue30,659M (2014)
Total assets276,002M (2014)
Number of employees
350 (2015)
Websitewww.novavax.com

Novavax, Inc. is a clinical-stage vaccine company headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden.


Pipeline

Novavax is developing a vaccine for respiratory syncytial virus (RSV), which is being studied in older adults, infants via maternal immunization and pediatrics.[1][2][3][4]

In 2011, Novavax was awarded a contract valued at up to $179 million by the Biomedical Advanced Research and Development Authority (BARDA) to develop both seasonal and pandemic influenza vaccines.[5]

The BARDA contract, which was originally intended, in part, to develop a vaccine for H5N1 avian influenza, was redirected to H7N9 avian influenza due to H7N9's higher case count. Novavax subsequently published Phase 1 clinical data in the New England Journal of Medicine indicating high levels of immunogenicity with its H7N9 influenza virus-like particle (VLP) vaccine.[6]

In April 2014, a team from Novavax and the University of Maryland published preclinical data on a vaccine candidate for MERS-CoV.[7]

In 2013, Novavax acquired the MatrixTM saponin-based adjuvant platform with the purchase of Swedish company Isconova AB.[8] The adjuvant is composed of saponins, cholesterol, and phosphatidylcholine.[9] Isconova AB currently operates as Novavax AB in Uppsala, Sweden.

Respiratory Syncytial Virus (RSV)

On August 10, 2015 Novavax announced positive top-line data from a Phase 2 clinical trial of its RSV-F vaccine in elderly adults.[10] Novavax' vaccine candidate demonstrated efficacy by reducing the risk of the disease by 46% when compared with placebo in 1,600 patients aged 60 and older.[11]

Each year, on average, in the United States, RSV leads to 177,000 hospitalizations and 14,000 deaths among adults older than 65 years.[12] There are currently no vaccines for approved for RSV.[13]

Novavax was awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to fund the development of the RSV F vaccine for infants through maternal immunization.[14] By vaccinating pregnant women, the antibodies produced by the mothers are passed on to the infants.[15] On September 29, 2015, clinical data from a Phase 2 study showed that the antibody levels in infants were 90% to 100% of the mothers' antibody levels.[14]

Ebola

Novavax researchers are able to precisely target the virus behind the current Ebola outbreak because they began their efforts with the known genetic sequence of the current viral strain.[16] Novavax synthesized the relevant genetic material from the most-current, published viral sequence data, and used a cell culture made from insect eggs to create multiple copies of the virus' genetic material.[16] These genetic copies are then used to produce Ebola proteins deemed most likely to prompt immune response.[16]

On July 21, 2015, Novavax announced positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-MTM.[17] In a randomized study, compared to placebo, the vaccine stimulated participants' immune systems to build up antibodies to fight Ebola when combined to fight Ebola when combined with supplement to boost production of the proteins.[17] The vaccine was tested in 230 healthy Australian adults, and the data showed that the vaccine was safe and well-tolerated.[17] The subjects in the trial developed an immune response against the deadly virus.[17]

See also

References

  1. ^ "A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults". clinicaltrials.gov. Retrieved 30 August 2016.
  2. ^ "A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization". clinicaltrials.gov. Retrieved 30 August 2016.
  3. ^ Glenn, Gregory M. (10 August 2015). "A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age". The Journal of Infectious Diseases. 213 (3): 411–422. doi:10.1093/infdis/jiv406. Retrieved 29 August 2016.
  4. ^ "A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age". clinicaltrials.gov. Retrieved 30 August 2016.
  5. ^ "Advanced Development of Recombinant Influenza Vaccine Products and Manufacturing Capabilities for Pandemic Preparedness - Federal Business Opportunities: Opportunities". www.fbo.gov. Retrieved 2015-12-23.
  6. ^ Fries, Louis F.; Smith, Gale E.; Glenn, Gregory M. (2013-12-26). "A Recombinant Viruslike Particle Influenza A (H7N9) Vaccine". New England Journal of Medicine. 369 (26): 2564–2566. doi:10.1056/NEJMc1313186. ISSN 0028-4793. PMID 24224560.
  7. ^ "Purified coronavirus spike protein nanoparticles induce coronavirus neutralizing antibodies in mice". Vaccine. 32: 3169–3174. doi:10.1016/j.vaccine.2014.04.016. Retrieved 2015-12-23. {{cite journal}}: Cite has empty unknown parameter: |1= (help)
  8. ^ "Novavax makes $30M bid for adjuvant business". FierceVaccines. Retrieved 2015-12-23.
  9. ^ Reimer, Jenny M.; Karlsson, Karin H.; Lövgren-Bengtsson, Karin; Magnusson, Sofia E.; Fuentes, Alexis; Stertman, Linda (2012-07-23). "Matrix-M™ Adjuvant Induces Local Recruitment, Activation and Maturation of Central Immune Cells in Absence of Antigen". PLoS ONE. 7 (7): e41451. doi:10.1371/journal.pone.0041451. PMC 3402407. PMID 22844480.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  10. ^ Grover, Natalie (10 August 2015). "Novavax hopes to crack elusive vaccine for common respiratory virus". Reuters. Retrieved 29 August 2016.
  11. ^ Bloomfield, Doni. "Novavax Surges on Vaccine Success Against Respiratory Disease". Bloomberg.com. Retrieved 2016-01-11.
  12. ^ Falsey, Ann R. (28 April 2005). "Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults". The New England Journal of Medicine. 352: 1749–1759. doi:10.1056/NEJMoa043951. Retrieved 29 August 2016.
  13. ^ Broadbent, Lindsay; Groves, Helen; Shields, Michael D.; Power, Ultan F. (2015-07-01). "Respiratory syncytial virus, an ongoing medical dilemma: an expert commentary on respiratory syncytial virus prophylactic and therapeutic pharmaceuticals currently in clinical trials". Influenza and Other Respiratory Viruses. 9 (4): 169–178. doi:10.1111/irv.12313. ISSN 1750-2659. PMC 4474493. PMID 25847510.
  14. ^ a b "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Retrieved 2016-01-11.
  15. ^ Koons, Cynthia; Gokhale, Ketaki (30 June 2016). "Why Drug Companies Want to Sell Vaccines to Pregnant Women". Bloomberg. Retrieved 29 August 2016.
  16. ^ a b c "In Ebola Crisis, New Vaccine Candidates Show Uncertain Promise". Forbes. Retrieved 2016-01-11.
  17. ^ a b c d Bloomfield, Doni. "Novavax Gains as Ebola Vaccine Shows Human Immune Response". Bloomberg. Retrieved 2016-01-11.
  • http://www.novavax.com/
  • Business data for Novavax, Inc.:
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