Novavax

Novavax, Inc.
Public
Traded as NASDAQ: NVAX
S&P 500 Component
Industry Biotechnology
Founded 1987 (1987)
Headquarters Gaithersburg, Maryland, United States
Area served
 Worldwide
Products Vaccines
Revenue 30,659M (2014)
Total assets 276,002M (2014)
Number of employees
 350 (2015)
Website www.novavax.com

Novavax, Inc. is a clinical-stage biopharmaceutical company committed to delivering novel products to prevent a broad range of infectious diseases. Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden.[1]

The company has recombinant vaccine engineering and manufacturing technology and adjuvant technology.

Pipeline

The company has initiated over 20 clinical trials as of December 8, 2015.[2][3] The company is conducting clinical trials of its respiratory syncytial virus (RSV) vaccine candidate in infants, older adults, and pregnant women.[4] Previous studies with the vaccine showed protection against RSV in cotton rats.[5]

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.[6]

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.[7]

In April 2014, a team from Novavax and the University of Maryland published preclinical data on a vaccine candidate for MERS-CoV.[8][9]

Respiratory Syncytial Virus (RSV)

On August 10, 2015 Novavax announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).[10] Novavax' vaccine candidate demonstrated efficacy by reducing the risk of the disease associated with lower respiratory infection by 46% when compared with placebo in 1,600 patients aged 60 and older.[11] According to the U.S. Centers for Disease Control and Prevention, there are currently no approved vaccines to prevent RSV, which kills about 14,000 American adults over 65 each year.[12] The study found 4.9% of participants who received placebo showed symptoms of RSV.[12]

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.[13] By vaccinating pregnant women, the antibodies produced by the mothers are passed on to the infants.[13] 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.[13]

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.[14] 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.[14] These genetic copies are then used to produce Ebola proteins deemed most likely to prompt immune response.[14]

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.[15] 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.[15] The vaccine was tested in 230 healthy Australian adults, and the data showed that the vaccine was safe and well-tolerated.[15] The subjects in the trial developed an immune response against the deadly virus.[15]

Adjuvants

In 2013, Novavax acquired the MatrixTM saponin-based adjuvant platform with the purchase of Swedish company Isconova AB.[16] The adjuvant is composed of saponins, cholesterol, and phosphatidylcholine.[17][18] Isconova AB currently operates as Novavax AB in Uppsala, Sweden.

See also

References

  1. ↑ "About Us – Novavax". novavax.com. Retrieved 2015-12-23.
  2. ↑ "Clinical Trials – Novavax". novavax.com. Retrieved 2015-12-23.
  3. ↑ "Search of: novavax - List Results - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2015-12-23.
  4. ↑ 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.
  5. ↑ Raghunandan, Rama; Lu, Hanxin; Zhou, Bin; Xabier, Mimi Guebre; Massare, Michael J.; Flyer, David C.; Fries, Louis F.; Smith, Gale E.; Glenn, Gregory M. (2014-11-12). "An insect cell derived respiratory syncytial virus (RSV) F nanoparticle vaccine induces antigenic site II antibodies and protects against RSV challenge in cotton rats by active and passive immunization". Vaccine 32 (48): 6485–6492. doi:10.1016/j.vaccine.2014.09.030.
  6. ↑ "Advanced Development of Recombinant Influenza Vaccine Products and Manufacturing Capabilities for Pandemic Preparedness - Federal Business Opportunities: Opportunities". www.fbo.gov. Retrieved 2015-12-23.
  7. ↑ 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.
  8. ↑ "Mers vaccine helps mice fight off deadly virus (Wired UK)". Wired UK. http://www.wired.co.uk/. Retrieved 2015-12-23. External link in |publisher= (help)
  9. ↑ "Purified coronavirus spike protein nanoparticles induce coronavirus neutralizing antibodies in mice". www.sciencedirect.com. Retrieved 2015-12-23.
  10. ↑ "Novavax hopes to crack elusive vaccine for common respiratory virus". Reuters. 2015-08-10. Retrieved 2016-01-11.
  11. ↑ Bloomfield, Doni. "Novavax Surges on Vaccine Success Against Respiratory Disease". Bloomberg.com. Retrieved 2016-01-11.
  12. 1 2 "RSV | Trends and Surveillance | Respiratory Syncytial Virus | CDC". www.cdc.gov. Retrieved 2016-01-11.
  13. 1 2 3 "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Retrieved 2016-01-11.
  14. 1 2 3 "In Ebola Crisis, New Vaccine Candidates Show Uncertain Promise". Forbes. Retrieved 2016-01-11.
  15. 1 2 3 4 Bloomfield, Doni. "Novavax Gains as Ebola Vaccine Shows Human Immune Response". Bloomberg.com. Retrieved 2016-01-11.
  16. ↑ "Novavax makes $30M bid for adjuvant business". FierceVaccines. Retrieved 2015-12-23.
  17. ↑ 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.
  18. ↑ Thomas, Dave (2013). "Direct Analysis of Multicomponent Vaccine Adjuvants by HPLC with Charged Aerosol Detection" (PDF). ThermoScientific. Retrieved 11 January 2016.

External links

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