Sanaria

Sanaria Inc.
Corporation
Industry Biotechnology
Founded 2003
Headquarters Rockville, Maryland, United States
Key people
 Stephen L. Hoffman, M.D., Founder
Products Malaria Vaccines
Number of employees
 < 100
Website www.sanaria.com

Sanaria is a biotechnology company developing vaccines protective against malaria, as well as related products for use in malaria research.[1] Sanaria’s vaccines are based on the use of the sporozoite (SPZ) stage of the malaria Plasmodium parasite as immunogen. Sanaria has developed the technology to grow and harvest large quantities of aseptic, purified Plasmodium falciparum (Pf) sporozoites and formulate them for use in vaccines for human use. Pf is responsible for the most of the approximately 500,000 deaths caused by malaria annually. [2][3][4][5] Sanaria's most advanced candidate vaccine is called PfSPZ Vaccine, which uses radiation attenuated (weakened) sporozoites, that cannot divide or cause disease, to induce these protective immune responses. Sanaria is developing other vaccines, including Sanaria PfSPZ-CVac, which uses unattenuated, infectious PfSPZ adminstered along with antimalarial drugs to induce protective immunity, and Sanaria PfSPZ-GA1, which uses genetically attenuated PfSPZ as immunogen. Sanaria is also developing methods for producing a vaccine that will prevent malaria caused by Plasmodium vivax, the second most important cause of malaria world-wide.[6] Additionally Sanaria produces PfSPZ reagents, also known as PfSPZ Challenge, which is used for controlled human malaria infections to assess the efficacy of new vaccines and drugs against malaria.[7]

Mission statement

Sanaria's primary mission is to develop and commercialize whole-parasite sporozoite vaccines that confer high-level, long-lasting protection against Plasmodium falciparum, the malaria parasite responsible for more than 95% of malaria associated severe illness and death world-wide and the malaria parasite for which there is the most significant drug resistance. The overall mission includes developing vaccines that prevent all human malaria and to use those vaccines to immunize the entire population in geographically defined areas so as to halt malaria transmission and thereby eliminate malaria.[8][9]

History

Sanaria Inc. used funds from a phase I Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to expand its R&D efforts and move into its first facility in Rockville, MD in July 2003.[10] In 2007, Sanaria received a $29-million grant from the Bill and Melinda Gates Foundation, administered through the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative (MVI) which secured their state-of-the-art manufacturing facility in Rockville, MD.[11][12] This facility has been used to manufacture PfSPZ Vaccine and other PfSPZ products for all clinical research studies to date. In 2009, Sanaria received approval from the FDA to test the vaccine in human trials,[11] the results of which have now been published extensively in high impact and internationally peer reviewed journals. PfSPZ Vaccine has shown consistently high level protection against , both controlled human malaria infection and naturally transmitted malaria, infection by Plasmodium falciparum.[13][14][15][16][17][18][19] Sanaria received FDA Fast Track Designation in 2016.[20]

I-PfSPZ-C

Sanaria’s entire R&D process is conducted with the collaboration of the International PfSPZ Consortium (I-PfSPZ-C), a group of 200 investigators and funders from ~40 organizations in ~20 countries who are dedicated to development of whole PfSPZ malaria vaccines that can be used to prevent malaria in individuals and systematically eliminate malaria from geographically defined areas of the world.[21]

In addition to the U.S. NIAID, U.S. DoD, and the BMGF, significant funding for development of PfSPZ vaccines has come from the Government of Equatorial Guinea and the corporate social responsibility arms of three U.S. energy companies (Marathon Oil, Noble Energy and AMPCO), Top Institute Pharma (the Netherlands) and universities in Nijmegen and Leiden, the Netherlands, the German Centre for Infection Research (DZIF), the Swiss Tropical Public Health Institute and the Swiss Government, and the Tanzanian Commission on Science and Technology.[22][23][24][25][26]

Awards

  • 2015 Montgomery County Bioscience Company of the Year at the 3rd Annual Montgomery County Small Business Awards[27]
  • 2014 Best Prophylactic Vaccine – World Vaccine Congress, Vaccine Industry Excellence Awards[28]
  • 2013 Emerging Business of the Year – Montgomery County Chamber of Commerce[29]
  • 2012 Commercialization Award – Maryland Biotech Center[30]
  • 2011 Biotechnology Firm of the Year – Tech Council of Maryland[31]
  • 2010 Ranked 15th in The Gazette of Politics and Business Exceptional 53 Business Award[32]
  • 2009 Best Early-Stage Vaccine Biotech – World Vaccine Congress Washington, Vaccine Industry Excellence Awards[33]
  • 2009 Ranked 22nd in The Gazette of Politics and Business Exceptional 53 Business Award[34]
  • 2008 Emerging Company of the Year – Tech Council of Maryland Tech Awards[35]

References

  1. ↑ "Malaria eradication through vaccination". Sanaria. Retrieved 2018-09-14.
  2. ↑ "Malaria". Our World in Data. Retrieved 2018-10-08.
  3. ↑ "UNICEF Eastern and Southern Africa - Media Centre - 25 April 2018: Ten things you didn't know about malaria". www.unicef.org. Retrieved 2018-10-08.
  4. ↑ "Severe Malaria". Malaria Site. 2015-02-27. Retrieved 2018-10-08.
  5. ↑ "Malaria". World Health Organization. Retrieved 2018-10-08.
  6. ↑ "Malaria". World Health Organization. Retrieved 2018-10-08.
  7. ↑ "Products". sanaria.com. Retrieved 2018-10-08.
  8. ↑ "Sanaria Foundation for Mission Statement". sanaria.com.
  9. ↑ "Sanaria Research & Development Plan". sanaria.com.
  10. ↑ "Sanaria | NIH SBIR/STTR". sbir.nih.gov. Retrieved 2018-10-08.
  11. 1 2 "Dr. Hoffman vs. the Mosquito - Washingtonian". 23 October 2013.
  12. ↑ "$29.3M Gates grant boosts Sanaria". www.gazette.net.
  13. ↑ Epstein JE, Tewari K, Lyke KE, Sim BK, Billingsley PF, Laurens MB, et al. (October 2011). "Live attenuated malaria vaccine designed to protect through hepatic CD8⁺ T cell immunity". Science. 334 (6055): 475–80. doi:10.1126/science.1211548. PMID 21903775.
  14. ↑ Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, et al. (September 2013). "Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine". Science. 341 (6152): 1359–65. doi:10.1126/science.1241800. PMID 23929949.
  15. ↑ Sissoko MS, Healy SA, Katile A, Omaswa F, Zaidi I, Gabriel EE, et al. (May 2017). "Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial". The Lancet. Infectious Diseases. 17 (5): 498–509. doi:10.1016/S1473-3099(17)30104-4. PMID 28216244.
  16. ↑ Olotu A, Urbano V, Hamad A, Eka M, Chemba M, Nyakarungu E, et al. (January 2018). "Advancing Global Health through Development and Clinical Trials Partnerships: A Randomized, Placebo-Controlled, Double-Blind Assessment of Safety, Tolerability, and Immunogenicity of PfSPZ Vaccine for Malaria in Healthy Equatoguinean Men". The American Journal of Tropical Medicine and Hygiene. 98 (1): 308–318. doi:10.4269/ajtmh.17-0449. PMC 5928718. PMID 29141739.
  17. ↑ Jongo SA, Shekalaghe SA, Church LW, Ruben AJ, Schindler T, Zenklusen I, et al. (August 2018). "Plasmodium falciparum Sporozoite Vaccine in Tanzanian Adults". The American Journal of Tropical Medicine and Hygiene. 99 (2): 338–349. doi:10.4269/ajtmh.17-1014. PMC 6090339. PMID 29943719.
  18. ↑ Ishizuka AS, Lyke KE, DeZure A, Berry AA, Richie TL, Mendoza FH, et al. (June 2016). "Protection against malaria at 1 year and immune correlates following PfSPZ vaccination". Nature Medicine. 22 (6): 614–23. doi:10.1038/nm.4110. PMID 27158907.
  19. ↑ Lyke KE, Ishizuka AS, Berry AA, Chakravarty S, DeZure A, Enama ME, et al. (March 2017). "Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection". Proceedings of the National Academy of Sciences of the United States of America. 114 (10): 2711–2716. doi:10.1073/pnas.1615324114. PMC 5347610. PMID 28223498.
  20. ↑ "Malaria vaccine wins FDA fast" (PDF). www.bizjournals.com. 2016.
  21. ↑ "Sanaria Foundation for Mission Statement". www.sanaria.com.
  22. ↑ LUMC. "First clinical trial volunteers injected with promising malaria vaccine | LUMC". www.lumc.nl. Retrieved 2018-10-08.
  23. ↑ "Subscribe to read". Financial Times. Retrieved 2018-10-08.
  24. ↑ "First controlled malaria infection trial in Africa paves way for drug and vaccine development". EurekAlert!. Retrieved 2018-10-08.
  25. ↑ "DZIF: New process allows tailor-made malaria research". www.dzif.de. Retrieved 2018-10-08.
  26. ↑ "DZIF: New malaria vaccine effective in clinical trial". www.dzif.de. Retrieved 2018-10-08.
  27. ↑ "Resources and Information". Montgomery County Government. Retrieved 2018-09-14.
  28. ↑ "Sanaria Wins ViE's "Best Prophylactic Vaccine" 2014". Pharmaceuticalonline.com. 2014-04-04. Retrieved 2018-09-14.
  29. ↑ "About the Awards and Past Winners". Montgomery County Chamber of Commerce. Archived from the original on 26 April 2017.
  30. ↑ Sohr N (3 May 2012). "State Awards Biotech Grants". Archived from the original on 18 February 2017.
  31. ↑ "Tech Council of Maryland Announces 2011 Tech Awards Finalists". Marketwired.com. 2011-04-15. Retrieved 2018-09-14.
  32. ↑ "P&B Exception 53" (PDF). The Gazette. Maryland Department of Commerce. September 2010. Retrieved 2018-09-14.
  33. ↑ "Malaria Vaccine Developer, Sanaria Inc., Receives 2009 Vaccine Industry Excellence Award for Best Early-Stage Vaccine Biotech". PR News Wire. Sanaria Inc. Archived from the original on 2 June 2009.
  34. ↑ "Awards". Sanaria. Archived from the original on 27 August 2018.
  35. ↑ "Tech Council of Maryland Announces Winners of the 20th Annual Dinner & Tech Awards Celebration". Business Wire. 2008-05-16. Retrieved 2018-09-14.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.