Sanaria

Sanaria is a biotechnology company developing vaccines protective against malaria and now recently COVID-19, 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. The SPZ stage of the malaria parasite is inoculated into humans by mosquito bite. Sanaria has developed the technology to grow and harvest aseptic, purified Plasmodium falciparum (Pf) SPZ 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 Sanaria® PfSPZ Vaccine, which uses radiation attenuated (weakened) SPZ, that cannot divide or cause disease, to induce these protective immune responses. Sanaria is developing other PfSPZ vaccines, including Sanaria® PfSPZ-CVac, which uses non-attenuated, infectious PfSPZ administered along with antimalarial drugs to induce protective immunity, and Sanaria® PfSPZ-GA1, which uses genetically attenuated PfSPZ as immunogen. Sanaria is also developing a vaccine that will prevent malaria caused by Plasmodium vivax, the second most important cause of malaria world-wide.[5] Additionally Sanaria produces PfSPZ products for clinical research. Sanaria® PfSPZ Challenge consists of purified, aseptic, non-attenuated PfSPZ and is used for controlled human malaria infections to assess the efficacy of new vaccines and drugs against malaria, and resistance to malaria.[6] As of 2020 a collaboration with the University of Tübingen, Sanaria Inc. and Protein Potential are developing a vaccine against COVID-19: OraCOV with promising development.[7]

Sanaria Inc.
TypeCorporation
IndustryBiotechnology
Founded2003
HeadquartersRockville, Maryland, United States
Key people
Stephen L. Hoffman, M.D., Founder
ProductsMalaria Vaccines, Corona vaccines
Number of employees
100
Websitewww.sanaria.com

Mission statement

Sanaria's primary mission is to develop and commercialize whole-parasite PfSPZ 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 entire populations in geographically defined areas to halt malaria transmission and thereby eliminate malaria.[8][9]

History

Sanaria moved into its first facility in Rockville, MD in July 2003 supported by 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) and a $4.09M grant from the United States Army Medical Research Acquisition Activity Group to further develop its vaccine.[10][11] In 2007, Sanaria received a $29.3-million grant from the Bill and Melinda Gates Foundation (BMGF), administered through the PATH Malaria Vaccine Initiative (MVI) which supported the construction of their manufacturing facility in Rockville, MD.[12][13] In 2009, Sanaria received approval from the FDA to test the vaccine in human trials,[12] the results of which have now been published in multiple high impact and internationally peer reviewed journals. Sanaria® PfSPZ Vaccine has shown high level protection against, both controlled human malaria infection and naturally transmitted malaria, infection by Plasmodium falciparum.[14][15][16][17][18][19][20] Sanaria received FDA Fast Track Designation in 2016.[21]

Clinical Trials

Nineteen clinical trials of PfSPZ Vaccine have been completed or are being conducted in Tanzania, Kenya, Mali, Burkina Faso, Gabon, Equatorial Guinea, Germany, the Netherlands, and the U.S.. Seven clinical trials of PfSPZ-CVac have been conducted in the Netherlands, the U.S., Germany, Equatorial Guinea and Mali.[22][23][24] PfSPZ-GA1 is being assessed in its first clinical trial in the Netherlands.[25] PfSPZ Challenge has enabled research teams worldwide to conduct controlled human malaria infection studies in the U.S., the Netherlands, Germany, United Kingdom, Spain, Tanzania, Kenya, Mali, Gabon, Equatorial Guinea, and the Gambia.[22][26][27]

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.[28]

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), universities in Nijmegen and Leiden, the Netherlands, the University of Tübingen, 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.[29][30][31][32][33]

European Union Malaria Fund

The European Union Malaria Fund (EUMF) is a public-private partnership between the European Union, international organizations, corporations, and organized civic society, providing a novel funding instrument to address market failures in infectious diseases with significant relevance to public health globally. The fund aims to fight malaria by furthering all modes of impact, including human vaccination.[34]

On November 5th, 2020, Sanaria Inc. entered into a contract with the EUMF to receive €12.9M for the development of two malaria vaccines, one malaria prophylactic, and a SARS-CoV-2 vaccine. [35]

Awards
  • 2020 Highly Commended Prophylactic Vaccine, 13th Annual Vaccine Industry Excellence Awards[36]
  • 2020 USPTO Patents for Humanity Award[37]
  • 2019 P3 Impact Award Winner, Concordia Summit[38][39]
  • 2015 Montgomery County Bioscience Company of the Year at the 3rd Annual Montgomery County Small Business Awards[40]
  • 2014 Best Prophylactic Vaccine – World Vaccine Congress, Vaccine Industry Excellence Awards[41]
  • 2013 Emerging Business of the Year – Montgomery County Chamber of Commerce[42]
  • 2012 Commercialization Award – Maryland Biotech Center[43]
  • 2011 Biotechnology Firm of the Year – Tech Council of Maryland[44]
  • 2010 Ranked 15th in The Gazette of Politics and Business Exceptional 53 Business Award[45]
  • 2009 Best Early-Stage Vaccine Biotech – World Vaccine Congress Washington, Vaccine Industry Excellence Awards[46]
  • 2009 Ranked 22nd in The Gazette of Politics and Business Exceptional 53 Business Award[47]
  • 2008 Emerging Company of the Year – Tech Council of Maryland Tech Awards[48]

References
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  2. Ritchie, Hannah; Roser, Max (2013-11-12). "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. "Products". sanaria.com. Retrieved 2018-10-08.
  7. "OraCOV vaccine against covid 19". sanaria.com.
  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. sanaria.com (PDF) http://sanaria.com/pdf/Press-11-4million-WBJ-6-03-05.pdf. Retrieved 2018-12-06. Missing or empty |title= (help)
  12. "Dr. Hoffman vs. the Mosquito - Washingtonian". 23 October 2013.
  13. "$29.3M Gates grant boosts Sanaria". www.gazette.net.
  14. 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. Bibcode:2011Sci...334..475E. doi:10.1126/science.1211548. PMID 21903775.
  15. 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. Bibcode:2013Sci...341.1359S. doi:10.1126/science.1241800. PMID 23929949.
  16. 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. PMC 6803168. PMID 28216244.
  17. 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.
  18. 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.
  19. 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 (Submitted manuscript). 22 (6): 614–23. doi:10.1038/nm.4110. PMID 27158907.
  20. 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.
  21. "Malaria vaccine wins FDA fast" (PDF). www.bizjournals.com. 2016.
  22. Richie, Thomas L.; Billingsley, Peter F.; Sim, B. Kim Lee; James, Eric R.; Chakravarty, Sumana; Epstein, Judith E.; Lyke, Kirsten E.; Mordmüller, Benjamin; Alonso, Pedro (2015-12-22). "Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines". Vaccine. 33 (52): 7452–7461. doi:10.1016/j.vaccine.2015.09.096. ISSN 0264-410X. PMC 5077156. PMID 26469720.
  23. "New malaria vaccine effective in clinical trial: Researchers achieve protection of up to 100 percent using fully viable malaria parasites". ScienceDaily. Retrieved 2018-10-18.
  24. "Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children - Full Text View - ClinicalTrials.gov". Retrieved 2018-10-18.
  25. "Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers - Full Text View - ClinicalTrials.gov". Retrieved 2018-10-18.
  26. "Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea. - Full Text View - ClinicalTrials.gov". Retrieved 2018-10-18.
  27. "Susceptibility of Gambian Adults to PfSPZ-Challenge Infection in the Controlled Human Malaria Infection Model - Full Text View - ClinicalTrials.gov". Retrieved 2018-10-18.
  28. "Sanaria Foundation for Mission Statement". www.sanaria.com.
  29. LUMC. "First clinical trial volunteers injected with promising malaria vaccine | LUMC". www.lumc.nl. Retrieved 2018-10-08.
  30. "Subscribe to read". Financial Times. Retrieved 2018-10-08. Cite uses generic title (help)
  31. "First controlled malaria infection trial in Africa paves way for drug and vaccine development". EurekAlert!. Retrieved 2018-10-08.
  32. "DZIF: New process allows tailor-made malaria research". www.dzif.de. Retrieved 2018-10-08.
  33. "DZIF: New malaria vaccine effective in clinical trial". www.dzif.de. Retrieved 2018-10-08.
  34. "controlMalaria". www.controlmalaria.eu. Retrieved 2020-11-09.
  35. "news". www.controlmalaria.eu. Retrieved 2020-11-09.
  36. "Sanaria PfSPZ Vaccines Wins Highly Commended Prophylactic Vaccine at the 13th Annual Vaccine Industry Excellence Awards – Sanaria". Retrieved 2020-11-04.
  37. "2020 award recipients". www.uspto.gov. Retrieved 2020-09-23.
  38. "P3 Impact Award". Concordia. Retrieved 2019-11-07.
  39. "Bioko Island Malaria Elimination Program". Concordia. Retrieved 2019-11-07.
  40. "Resources and Information". Montgomery County Government. Retrieved 2018-09-14.
  41. "Sanaria Wins ViE's "Best Prophylactic Vaccine" 2014". Pharmaceuticalonline.com. 2014-04-04. Retrieved 2018-09-14.
  42. "About the Awards and Past Winners". Montgomery County Chamber of Commerce. Archived from the original on 26 April 2017.
  43. Sohr N (3 May 2012). "State Awards Biotech Grants". Archived from the original on 18 February 2017.
  44. "Tech Council of Maryland Announces 2011 Tech Awards Finalists". Marketwired.com. 2011-04-15. Retrieved 2018-09-14.
  45. "P&B Exception 53" (PDF). The Gazette. Maryland Department of Commerce. September 2010. Retrieved 2018-09-14.
  46. "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 19 May 2017.
  47. "Awards". Sanaria. Archived from the original on 27 August 2018.
  48. "Tech Council of Maryland Announces Winners of the 20th Annual Dinner & Tech Awards Celebration". Business Wire. 2008-05-16. Retrieved 2018-09-14.
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