Novavax

Coordinates: 39°08′14″N 77°13′33″W / 39.1371167°N 77.2258056°W / 39.1371167; -77.2258056

Novavax, Inc.
Public
Traded as NASDAQ: NVAX
S&P 500 Component
Industry Biotechnology
Founded 1987 (1987)
Headquarters Gaithersburg, Maryland, U.S.
Area served
 Worldwide
Products Vaccines
Revenue 36.259M (2015)
Total assets 386.042M (2015)
Number of employees
 350 (2015)
Website www.novavax.com

Novavax, Inc. is a clinical-stage vaccine company headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is a public company that trades under the symbol "NVAX".[1] In June 2013, Novavax acquired the Matrix-MTM adjuvant platform with the purchase of Swedish company Isconova AB.[2]

Pipeline

Respiratory Syncytial Virus (RSV)

Novavax is developing a vaccine candidate for respiratory syncytial virus (RSV), which is being studied in older adults, infants via maternal immunization and pediatrics.[3][4][5][6] There are currently no vaccines approved for RSV.[7]

Novavax announced positive top-line data from a Phase 2 clinical trial of its RSV-F vaccine in older adults.[8][9][10] A Phase 3 clinical trial of the RSV-F vaccine for older adults was initiated in November 2015.[11] In September 2016, Novavax announced that its RSV-F vaccine for lower respiratory tract disease did not meet its objectives in a clinical trial. The vaccine was well-tolerated by patients. But it did not demonstrate efficacy in preventing RSV-associated lower respiratory tract disease or reducing the occurrence of all symptomatic respiratory disease, according to a company statement. Company's stock collapsed more than 85% after the announcement.[12]

The Bill & Melinda Gates Foundation granted $89 million to support the development of the RSV-F vaccine for infants via maternal immunization based on positive top-line Phase 2 clinical data.[13][14][15][16] A Phase 3 clinical trial of the RSV-F vaccine for infants via maternal immunization was initiated in December 2015.[17]

Influenza

In March 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.[18][19] Novavax announced positive top-line Phase 2 data quadrivalent seasonal flu vaccine in July 2015.[20] Novavax announced positive top-line Phase 1/2 clinical data for its H7N9 avian influenza vaccine in September 2014.[21]

Ebola

Novavax is developing a Ebola virus vaccine candidate and initiated a Phase 1 clinical trial of the vaccine in February 2015.[22][23][24][25][26][27] In July 2015, Novavax announced positive top-line data from the trial.[28][29][30]

Middle East Respiratory Syndrome (MERS)

In April 2014, the University of Maryland and Novavax published preclinical data on a vaccine candidate for Middle East respiratory syndrome coronavirus (MERS-CoV).[31]

See also

References

  1. ↑ "Novavax, Inc. News Headlines". NASDAQ. Retrieved 8 September 2016.
  2. ↑ Taylor, Nick Paul (3 June 2013). "Novavax makes $30M bid for adjuvant business". FiercePharma. Retrieved 9 September 2016.
  3. ↑ "A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults". clinicaltrials.gov. Retrieved 30 August 2016.
  4. ↑ "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.
  5. ↑ 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.
  6. ↑ "A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age". clinicaltrials.gov. Retrieved 30 August 2016.
  7. ↑ 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 4474493Freely accessible. PMID 25847510.
  8. ↑ Bloomfield, Doni (10 August 2015). "Novavax Surges on Vaccine Success Against Respiratory Disease". Bloomberg. Retrieved 8 September 2016.
  9. ↑ Grover, Natalie (10 August 2015). "Novavax hopes to crack elusive vaccine for common respiratory virus". Reuters. Retrieved 8 September 2016.
  10. ↑ Al Idrus, Amirah (12 August 2015). "Novavax reports positive top-line data from PhII trial of RSV vaccine". FiercePharma. Retrieved 8 September 2016.
  11. ↑ Al Idrus, Amirah (11 November 2015). "Novavax kicks off PhIII trial for its RSV vaccine". FiercePharma. Retrieved 8 September 2016.
  12. ↑ "Novavax Stock Tanking in After-Hours Trading on Vaccine Trial Failure". TheStreet. Retrieved 16 September 2016.
  13. ↑ Reed, Tina (29 September 2015). "Gaithersburg biotech receives grant worth up to $89 million grant from Gates Foundation". The Washington Business Journal. Retrieved 8 September 2016.
  14. ↑ Carroll, John (29 September 2015). "With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII". FierceBiotech. Retrieved 8 September 2016.
  15. ↑ Grover, Natalie (29 September 2015). "Novavax RSV vaccine found safe for pregnant women, fetus". Reuters. Retrieved 8 September 2016.
  16. ↑ Herper, Matt (29 September 2015). "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Retrieved 8 September 2016.
  17. ↑ Al Idrus, Amirah (8 December 2015). "Novavax takes RSV vaccine into Phase III ahead of schedule". FiercePharma. Retrieved 8 September 2016.
  18. ↑ "Advanced Development of Recombinant Influenza Vaccine Products and Manufacturing Capabilities for Pandemic Preparedness - Federal Business Opportunities: Opportunities". www.fbo.gov. Retrieved 2015-12-23.
  19. ↑ Clabaugh, Jeff (1 March 2011). "Novavax gets $97M for new flu vaccines". The Washington Business Journal. Retrieved 8 September 2016.
  20. ↑ Al Idrus, Amirah (3 August 2015). "Novavax reports PhII success for quadrivalent seasonal flu vax". FiercePharma. Retrieved 8 September 2016.
  21. ↑ Helfand, Carly (30 October 2014). "Novavax nabs FDA fast-track tag as search for H7N9 vaccine continues". FiercePharma. Retrieved 8 September 2016.
  22. ↑ "Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects". clinicaltrials.gov. Retrieved 8 September 2016.
  23. ↑ Flam, Faye (28 October 2014). "In Ebola Crisis, New Vaccine Candidates Show Uncertain Promise". Forbes. Retrieved 8 September 2016.
  24. ↑ Grover, Natalie (12 February 2015). "Novavax starts Ebola vaccine trial in humans". Reuters. Retrieved 8 September 2016.
  25. ↑ Overly, Steven (28 October 2014). "Gaithersburg-based Novavax developing vaccine to prevent spread of Ebola". The Washington Post. Retrieved 8 September 2016.
  26. ↑ Grover, Natalie. "Novavax starts Ebola vaccine trial in humans". Reuters (12 February 2015). Retrieved 8 September 2016.
  27. ↑ Reed, Tina (12 February 2015). "Gaithersburg's Novavax begins Phase 1 Ebola vaccine trials". The Washington Business Journal. Retrieved 8 September 2016.
  28. ↑ Bloomfield, Doni. "Novavax Gains as Ebola Vaccine Shows Human Immune Response". Bloomberg (21 July 2015). Retrieved 8 September 2016.
  29. ↑ Grover, Natalie (21 July 2015). "Novavax's Ebola vaccine shows promise in early-stage trial". Reuters. Retrieved 8 September 2016.
  30. ↑ Al Idrus, Amirah (22 July 2015). "Novavax's Ebola vaccine shows promise in PhI". FiercePharma. Retrieved 8 September 2016.
  31. ↑ "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.
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