Sanaria Inc.
TypeCorporation
IndustryBiotechnology
Founded2003
FounderStephen L. Hoffman
HeadquartersRockville, Maryland, United States
ProductsMalaria Vaccines, COVID-19 Vaccines
Number of employees
65
Websitewww.sanaria.com

Sanaria is a biotechnology company developing vaccines protective against malaria and other infectious diseases 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 parasite, Plasmodium, as an immunogen, and as a platform technology for liver-vectored gene delivery. SPZ are normally introduced into humans by mosquito bite where they migrate to the liver and further develop to liver stages, and eventually back into the blood stream where the parasite infects red blood cells (RBC) and causes malaria. Plasmodium falciparum is the species responsible for more than 95% deaths caused by malaria.[2][3][4][5] The WHO estimates there were 249 million clinical cases and 608,000 deaths in 2022 alone.[6][7][8]

Sanaria has developed the technology to grow and harvest aseptic, purified Plasmodium falciparum (Pf) SPZ and formulate them as vaccines for human use. Sanaria's first generation vaccine is called Sanaria® PfSPZ Vaccine, and uses radiation attenuated (weakened) SPZ, that cannot divide or cause disease, to induce these protective immune responses in the liver. The next generation vaccines are attenuated differently. Sanaria® PfSPZ-CVac, uses infectious PfSPZ administered along with antimalarial drugs to develop through the liver stage and be killed before infecting RBCs and induce protective immunity. Sanaria® PfSPZ-LARC2 Vaccine is genetically attenuated to arrest (halt development) late in the liver stages of the life cycle. Sanaria is also developing a vaccine that will prevent malaria caused by Plasmodium vivax, the second most important type of malaria parasite worldwide[5] and is expanding its PfSPZ platform to develop vaccines for other diseases where an immune response in the liver may be beneficial, such as chronic hepatitis.

In addition to vaccines, Sanaria produces PfSPZ products for clinical research. Sanaria® PfSPZ Challenge consists of purified, aseptic, infectious PfSPZ and is used for controlled human malaria infections to assess the efficacy of vaccines and drugs against malaria, and acquired or induced immunity and resistance to malaria infection.[9]

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 worldwide and the malaria parasite for which there is the most significant drug resistance. The overall mission includes 1) developing vaccines that prevent all human malaria and using these vaccines to immunize entire populations in geographically defined areas to halt malaria transmission and thereby eliminate malaria[10][11] and 2) developing vaccines for prevention or treatment of other infectious diseases, and diseases of the liver.

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 subsequently by a $4.09M grant from the United States Army Medical Research Acquisition Activity Group to further develop its vaccine.[12][13] 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 Sanaria's manufacturing facility in Rockville, MD.[14][15] In 2009, Sanaria received approval from the FDA to test PfSPZ Vaccine in human trials.[14] Sanaria® PfSPZ Vaccine is highly protective against Pf malaria transmitted by controlled human malaria infection (CHMI) and naturally transmitted malaria.[16][17][18][19][20][21][22] PfSPZ Vaccine received FDA Fast Track Designation in 2016.[23] Sanaria's second generation baccine,PfSPZ-CVac (CQ) has shown even stronger protection against CHMI at a much lower dose than PfSPZ Vaccine.[24][25] Sanaria® PfSPZ-LARC2 Vaccine, developed most recently, has been manufactured and is expected to be assessed in clinical trials in 2023 and 2024.

Clinical Trials

Twenty-two clinical trials of PfSPZ Vaccine(radiation-attenuated SPZ) have been completed or are being conducted in Tanzania, Kenya, Mali, Burkina Faso, Gabon, Equatorial Guinea, Germany, the Netherlands, Indonesia, and the U.S.. Recent results from a study in women of child-bearing potential in Mali[26][27] showed significant vaccine efficacy (VE) against both malaria infection and clinical malaria over 18 months ranging from 40 to 85%.  Many of the women participating in the trial became pregnant during follow-up post immunization and VE during pregnancy against malaria infection was 49-57%. Based on these results, a new clinical trial will be initiated in 2023 in pregnant Malian women who will be immunized in the second or third trimesters to see if PfSPZ Vaccine is safe during pregnancy and will reduce the maternal and fetal morbidity and mortality associated with pregnancy malaria. This study will be conducted by the Malaria Research and Training Center, University of Bamako, and the Laboratory of Malaria Immunology and Vaccinology, NIAID, with Sanaria sponsorship. A second trial in 6–10-year-old Malian children was initiated in 2022 by the same collaborators.[28]

Eleven clinical trials of PfSPZ-CVac (chemo-attenuated SPZ) have been or are being conducted in the Netherlands, the U.S., Germany, Equatorial Guinea, Mali, and Indonesia. In a 2021 article in Nature, two Phase I clinical trials of PfSPZ-CVac were highlighted for efficacy against a malaria parasite variant, including 100% protection at three months after immunization, marking by far the best protection ever achieved in the history of malaria vaccine development.[25][29][30]

A vaccine that relies on targeted genetic alteration (gene deletion). arrests early during the liver stage. This vaccine, called Sanaria® PfSPZ-GA1 was assessed in its first clinical trial in the Netherlands.[31] While this vaccine was safe, it did not offer any advantages over PfSPZ Vaccine, and is not being pursued further. Sanaria is now preparing for first-in-human clinical trials of PfSPZ-LARC2 Vaccine, a late-arresting, replication-competent genetically altered parasite with improved antigen expression compared to PfSPZ-GA1. PfSPZ-LARC2 vaccine is predicted to equal PfSPZ-CVac (chloroquine) in potency and have the same excellent safety profile as PfSPZ Vaccine. This new generation genetically altered parasite is being developed in collaboration with the Seattle Children's Research Institute.[32]

An important Sanaria product is non-attenuated sporozoites, called Sanaria® PfSPZ Challenge. This is the immunogen used in PfSPZ-CVac and can be used to infect research participants with P. falciparum malaria to test the efficacy of vaccines and drugs (called controlled human malaria infection, or CHMI) and the impact of innate and acquired immunity and genetic background on malaria.  The fully infectious sporozoites of PfSPZ Challenge have enabled research teams worldwide to conduct CHMI studies, including in the U.S., the Netherlands, Germany, United Kingdom, Spain, Tanzania, Kenya, Mali, Gabon, Equatorial Guinea, and the Gambia.[29][33][34] Sanaria has two variants of PfSPZ Challenge, one from West Africa and one from Brazil, and plans to develop additional variants in the coming years.

I-PfSPZ-C

Sanaria's research and development is conducted with the collaboration of the International PfSPZ Consortium (I-PfSPZ-C), a group of ~290 investigators and funders from 86 organizations in 28 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.[35][36] The I-PfSPZ-C meets 1-2 times each year to present data, discuss ideas, and map out plans for future studies in an open forum.

Funding

In addition to 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.[37][38][39][40][41]

In 2020, Sanaria Inc. received €12.9M from the European Union Malaria Fund (EUMF) for the development of two malaria vaccines, one malaria prophylactic, and a SARS-CoV-2 vaccine.[42][43]

References

  1. ↑ "Malaria eradication through vaccination". Sanaria. Retrieved September 14, 2018.
  2. ↑ Ritchie, Hannah; Roser, Max (November 12, 2013). "Malaria". Our World in Data. Retrieved October 8, 2018.
  3. ↑ "UNICEF Eastern and Southern Africa - Media Centre - 25 April 2018: Ten things you didn't know about malaria". www.unicef.org. Retrieved October 8, 2018.
  4. ↑ "Severe Malaria". Malaria Site. February 27, 2015. Retrieved October 8, 2018.
  5. 1 2 "Malaria". World Health Organization. Retrieved October 8, 2018.
  6. ↑ "World malaria report 2021". www.who.int. Retrieved January 12, 2022.
  7. ↑ "World malaria report 2022". www.who.int. Retrieved April 26, 2023.
  8. ↑ "World malaria report 2023". www.who.int. Retrieved December 5, 2023.
  9. ↑ "Products". sanaria.com. Retrieved October 8, 2018.
  10. ↑ "Sanaria Foundation for Mission Statement". sanaria.com.
  11. ↑ "Sanaria Research & Development Plan". sanaria.com.
  12. ↑ "Sanaria | NIH SBIR/STTR". sbir.nih.gov. Retrieved October 8, 2018.
  13. ↑ Adler, Neil (June 3, 2005). "Sanaria gets $4M in gov't funds for malaria vaccine" (PDF). sanaria.com. Washington Business Journal. Archived from the original (PDF) on November 28, 2011. Retrieved June 10, 2023.
  14. 1 2 "Dr. Hoffman vs. the Mosquito - Washingtonian". October 23, 2013.
  15. ↑ "$29.3M Gates grant boosts Sanaria". www.gazette.net.
  16. ↑ 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. S2CID 206536528.
  17. ↑ 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. S2CID 22462258.
  18. ↑ 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.
  19. ↑ 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.
  20. ↑ 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.
  21. ↑ 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. S2CID 205396815.
  22. ↑ 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.
  23. ↑ "Malaria vaccine wins FDA fast" (PDF). Washington Business Journal. 2016.
  24. ↑ Mordmüller, Benjamin; Surat, Güzin; Lagler, Heimo; Chakravarty, Sumana; Ishizuka, Andrew S.; Lalremruata, Albert; Gmeiner, Markus; Campo, Joseph J.; Esen, Meral; Ruben, Adam J.; Held, Jana (February 2017). "Sterile protection against human malaria by chemoattenuated PfSPZ vaccine". Nature. 542 (7642): 445–449. Bibcode:2017Natur.542..445M. doi:10.1038/nature21060. ISSN 1476-4687. PMID 28199305. S2CID 205253429.
  25. 1 2 Mwakingwe-Omari, Agnes; Healy, Sara A.; Lane, Jacquelyn; Cook, David M.; Kalhori, Sahand; Wyatt, Charles; Kolluri, Aarti; Marte-Salcedo, Omely; Imeru, Alemush; Nason, Martha; Ding, Lei K. (July 2021). "Two chemoattenuated PfSPZ malaria vaccines induce sterile hepatic immunity". Nature. 595 (7866): 289–294. Bibcode:2021Natur.595..289M. doi:10.1038/s41586-021-03684-z. hdl:1721.1/142862. ISSN 1476-4687. PMID 34194041. S2CID 235696393.
  26. ↑ National Institute of Allergy and Infectious Diseases (NIAID) (May 19, 2022). "Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali". Malaria Research and Training Center, University of Science Techniques and Technologies of Bamako Sanaria Inc. {{cite journal}}: Cite journal requires |journal= (help)
  27. ↑ "ASTMH 2021 Annual Meeting". app.core-apps.com. Retrieved July 21, 2022.
  28. ↑ "Sanaria Announces the Start of Clinical Trials of its PfSPZ Vaccines in Mali and Indonesia – Sanaria". Retrieved July 8, 2022.
  29. 1 2 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 (December 22, 2015). "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.
  30. ↑ "New malaria vaccine effective in clinical trial: Researchers achieve protection of up to 100 percent using fully viable malaria parasites". ScienceDaily. Retrieved October 18, 2018.
  31. ↑ "Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers - Full Text View - ClinicalTrials.gov". Retrieved October 18, 2018.
  32. ↑ "SANARIA INC. AND SEATTLE CHILDREN'S RESEARCH INSTITUTE ANNOUNCE COLLABORATION FOR DEVELOPMENT OF GENETICALLY ATTENUATED MALARIA VACCINES – Sanaria". Retrieved July 8, 2022.
  33. ↑ "Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea. - Full Text View - ClinicalTrials.gov". Retrieved October 18, 2018.
  34. ↑ "Susceptibility of Gambian Adults to PfSPZ-Challenge Infection in the Controlled Human Malaria Infection Model - Full Text View - ClinicalTrials.gov". Retrieved October 18, 2018.
  35. ↑ "Sanaria Foundation for Mission Statement". www.sanaria.com.
  36. ↑ "Major Breakthroughs Presented at the International PfSPZ Consortium Meeting – Sanaria". Retrieved January 12, 2022.
  37. ↑ LUMC. "First clinical trial volunteers injected with promising malaria vaccine | LUMC". www.lumc.nl. Retrieved October 8, 2018.
  38. ↑ "Hopes rise for malaria vaccine as oil companies fund trials". Financial Times. Archived from the original on May 24, 2021. Retrieved October 8, 2018.
  39. ↑ "First controlled malaria infection trial in Africa paves way for drug and vaccine development". EurekAlert!. Retrieved October 8, 2018.
  40. ↑ "DZIF: New process allows tailor-made malaria research". www.dzif.de. Retrieved October 8, 2018.
  41. ↑ "DZIF: New malaria vaccine effective in clinical trial". www.dzif.de. Retrieved October 8, 2018.
  42. ↑ "news". www.controlmalaria.eu. Retrieved November 9, 2020.
  43. ↑ "controlMalaria". www.controlmalaria.eu. Retrieved November 9, 2020.
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