Sanaria

Last updated

Sanaria Inc.
Company typeCorporation
IndustryBiotechnology
Founded2003
FounderStephen L. Hoffman
Headquarters Rockville, Maryland, United States
ProductsMalaria Vaccines
Number of employees
55
Website www.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]

Contents

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 vaccine, 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 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 41 to 86%.  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 planned for 2024/2025 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. [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 have better potency than PfSPZ-CVac (chloroquine) 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]

Related Research Articles

<span class="mw-page-title-main">Malaria</span> Mosquito-borne infectious disease

Malaria is a mosquito-borne infectious disease that affects humans and other vertebrates. Human malaria causes symptoms that typically include fever, fatigue, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death. Symptoms usually begin 10 to 15 days after being bitten by an infected Anopheles mosquito. If not properly treated, people may have recurrences of the disease months later. In those who have recently survived an infection, reinfection usually causes milder symptoms. This partial resistance disappears over months to years if the person has no continuing exposure to malaria.

<i>Plasmodium falciparum</i> Protozoan species of malaria parasite

Plasmodium falciparum is a unicellular protozoan parasite of humans, and the deadliest species of Plasmodium that causes malaria in humans. The parasite is transmitted through the bite of a female Anopheles mosquito and causes the disease's most dangerous form, falciparum malaria. It is responsible for around 50% of all malaria cases. P. falciparum is therefore regarded as the deadliest parasite in humans. It is also associated with the development of blood cancer and is classified as a Group 2A (probable) carcinogen.

<span class="mw-page-title-main">Gametocyte</span> Eukaryotic germ stem cell

A gametocyte is a eukaryotic germ cell that divides by mitosis into other gametocytes or by meiosis into gametids during gametogenesis. Male gametocytes are called spermatocytes, and female gametocytes are called oocytes.

<i>Plasmodium vivax</i> Species of single-celled organism

Plasmodium vivax is a protozoal parasite and a human pathogen. This parasite is the most frequent and widely distributed cause of recurring malaria. Although it is less virulent than Plasmodium falciparum, the deadliest of the five human malaria parasites, P. vivax malaria infections can lead to severe disease and death, often due to splenomegaly. P. vivax is carried by the female Anopheles mosquito; the males do not bite.

<i>Plasmodium ovale</i> Species of single-celled organism

Plasmodium ovale is a species of parasitic protozoon that causes tertian malaria in humans. It is one of several species of Plasmodium parasites that infect humans, including Plasmodium falciparum and Plasmodium vivax which are responsible for most cases of malaria in the world. P. ovale is rare compared to these two parasites, and substantially less dangerous than P. falciparum.

<i>Plasmodium malariae</i> Species of single-celled organism

Plasmodium malariae is a parasitic protozoan that causes malaria in humans. It is one of several species of Plasmodium parasites that infect other organisms as pathogens, also including Plasmodium falciparum and Plasmodium vivax, responsible for most malarial infection. Found worldwide, it causes a so-called "benign malaria", not nearly as dangerous as that produced by P. falciparum or P. vivax. The signs include fevers that recur at approximately three-day intervals – a quartan fever or quartan malaria – longer than the two-day (tertian) intervals of the other malarial parasite.

<i>Plasmodium knowlesi</i> Species of single-celled organism

Plasmodium knowlesi is a parasite that causes malaria in humans and other primates. It is found throughout Southeast Asia, and is the most common cause of human malaria in Malaysia. Like other Plasmodium species, P. knowlesi has a life cycle that requires infection of both a mosquito and a warm-blooded host. While the natural warm-blooded hosts of P. knowlesi are likely various Old World monkeys, humans can be infected by P. knowlesi if they are fed upon by infected mosquitoes. P. knowlesi is a eukaryote in the phylum Apicomplexa, genus Plasmodium, and subgenus Plasmodium. It is most closely related to the human parasite Plasmodium vivax as well as other Plasmodium species that infect non-human primates.

Malaria prophylaxis is the preventive treatment of malaria. Several malaria vaccines are under development.

Malaria vaccines are vaccines that prevent malaria, a mosquito-borne infectious disease which annually affects an estimated 247 million people worldwide and causes 619,000 deaths. The first approved vaccine for malaria is RTS,S, known by the brand name Mosquirix. As of April 2023, the vaccine has been given to 1.5 million children living in areas with moderate-to-high malaria transmission. It requires at least three doses in infants by age 2, and a fourth dose extends the protection for another 1–2 years. The vaccine reduces hospital admissions from severe malaria by around 30%.

Pregnancy-associated malaria (PAM) or placental malaria is a presentation of the common illness that is particularly life-threatening to both mother and developing fetus. PAM is caused primarily by infection with Plasmodium falciparum, the most dangerous of the four species of malaria-causing parasites that infect humans. During pregnancy, a woman faces a much higher risk of contracting malaria and of associated complications. Prevention and treatment of malaria are essential components of prenatal care in areas where the parasite is endemic – tropical and subtropical geographic areas. Placental malaria has also been demonstrated to occur in animal models, including in rodent and non-human primate models.

<span class="mw-page-title-main">RTS,S</span> Malaria vaccine

RTS,S/AS01 is a recombinant protein-based malaria vaccine. It is one of two malaria vaccines approved. As of April 2022, the vaccine has been given to 1 million children living in areas with moderate-to-high malaria transmission, with millions more doses to be provided as the vaccine's production expands. 18 million doses have been allocated for 2023-2025. It requires at least three doses in infants by age 2, with a fourth dose extending the protection for another 1–2 years. The vaccine reduces hospital admissions from severe malaria by around 30% and reduces toddler deaths by 15%.

Plasmodium coatneyi is a parasitic species that is an agent of malaria in nonhuman primates. P. coatneyi occurs in Southeast Asia. The natural host of this species is the rhesus macaque and crab-eating macaque, but there has been no evidence that zoonosis of P. coatneyi can occur through its vector, the female Anopheles mosquito.

Circumsporozoite protein (CSP) is a secreted protein of the sporozoite stage of the malaria parasite and is the antigenic target of RTS,S and other malaria vaccines. The amino-acid sequence of CSP consists of an immunodominant central repeat region flanked by conserved motifs at the N- and C- termini that are implicated in protein processing as the parasite travels from the mosquito to the mammalian vector. The amino acid sequence of CSP was determined in 1984.

PfSPZ Vaccine is a metabolically active non-replicating whole sporozoite (SPZ) malaria vaccine being developed by Sanaria against Plasmodium falciparum (Pf) malaria. Clinical trials have been safe, extremely well tolerated and highly efficacious. The first generation PfSPZ product is attenuated by gamma irradiation; the second generation vaccines PfSPZ-CVac and PfSPZ LARC2 are, respectively, attenuated chemically and genetically. Multiple studies are ongoing with trials of the PfSPZ vaccines. All three products are produced using the same manufacturing process. These products are stored and distributed below -150 °C using liquid nitrogen (LN2) vapor phase (LNVP) freezers and cryoshippers.

Ruth Sonntag Nussenzweig was an Austrian-Brazilian immunologist specializing in the development of malaria vaccines. In a career spanning over 60 years, she was primarily affiliated with New York University (NYU). She served as C.V. Starr Professor of Medical and Molecular Parasitology at Langone Medical Center, Research Professor at the NYU Department of Pathology, and finally Professor Emerita of Microbiology and Pathology at the NYU Department of Microbiology.

<i>Plasmodium cynomolgi</i> Species of single-celled organism

Plasmodium cynomolgi is an apicomplexan parasite that infects mosquitoes and Asian Old World monkeys. In recent years, a number of natural infections of humans have also been documented. This species has been used as a model for human Plasmodium vivax because Plasmodium cynomolgi shares the same life cycle and some important biological features with P. vivax.

Plasmodium falciparum erythrocyte membrane protein 1 (PfEMP1) is a family of proteins present on the membrane surface of red blood cells that are infected by the malarial parasite Plasmodium falciparum. PfEMP1 is synthesized during the parasite's blood stage inside the RBC, during which the clinical symptoms of falciparum malaria are manifested. Acting as both an antigen and adhesion protein, it is thought to play a key role in the high level of virulence associated with P. falciparum. It was discovered in 1984 when it was reported that infected RBCs had unusually large-sized cell membrane proteins, and these proteins had antibody-binding (antigenic) properties. An elusive protein, its chemical structure and molecular properties were revealed only after a decade, in 1995. It is now established that there is not one but a large family of PfEMP1 proteins, genetically regulated (encoded) by a group of about 60 genes called var. Each P. falciparum is able to switch on and off specific var genes to produce a functionally different protein, thereby evading the host's immune system. RBCs carrying PfEMP1 on their surface stick to endothelial cells, which facilitates further binding with uninfected RBCs, ultimately helping the parasite to both spread to other RBCs as well as bringing about the fatal symptoms of P. falciparum malaria.

Peter Gottfried Kremsner is a specialist in tropical medicine and Full Professor at the University of Tübingen, Germany. Since 1992 he has been leading the Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon, now as president.

Sanjeev Krishna,, is a British physician and parasitologist whose research focuses on affordable diagnosis and treatment of diseases such as COVID-19, malaria, Ebola, African trypanosomiasis, leishmaniasis, and colorectal cancer. Krishna is Professor of Medicine and Molecular Parasitology at St George's, University of London and St George's Hospital.

Stephen L. Hoffman is an American physician-scientist, tropical medicine specialist and vaccinologist, who is the founder and chief executive and scientific officer of Sanaria Inc., a company dedicated to developing PfSPZ vaccines to prevent malaria.

References

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