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Sanaria Inc. announced that two new Phase 2 trials of its pioneering malaria vaccines have started. The first is in 6- to 10-year-old children living in Bancoumana, Mali, a malarious region of West Africa. The second is in Indonesian soldiers based in Sumatra, Indonesia. The soldiers will be deploying for six to nine months this coming August to an intensely malarious district in eastern Indonesia.

EOCRU team member working in the clinic with a soldier

“We are extremely excited to be sponsoring these two trials,” said Sanaria CEO Stephen L. Hoffman. “Both will examine the ability of our vaccines to protect against naturally transmitted malaria in populations that are highly susceptible to this deadly parasitic infection – children in Mali, and military personnel.”

Malaria vaccine

Sanaria Inc. has been developing vaccines against Plasmodium falciparum (Pf) since 2003.  Pf is the deadliest of the five types of parasites causing malaria in humans.  It was responsible for 627,000 deaths in 2020, the most deaths since 2012, mostly in children and pregnant women in sub-Saharan Africa.  Sanaria’s vaccines are composed of the infectious form of the Pf parasite, called the sporozoite (SPZ). The PfSPZ are attenuated by radiation, co-administration of an antimalarial drug, or gene-knockout, so that they can be administered safely to people.  The highly purified product has no adjuvant and injections have been safe and well tolerated in multiple trials.

Clinical trial in Mali

The Mali trial is being performed by the Malaria Research and Training Center (MRTC), University of Bamako, in collaboration with the Laboratory of Malaria Immunology and Vaccinology (LMIV) of the US National Institute of Allergy and Infectious Diseases (NIAID).  Dr. Issaka Sagara is the lead investigator from MRTC, and Dr. David Cook from LMIV.  Reflecting on the trial, Dr. Sagara stated “the children of Mali suffer tremendously from Pf malaria, particularly during the rainy season, which extends from July to December each year. Currently, we have a national program to provide antimalarial drugs during this period to 1- to 5-year-olds (called seasonal malaria chemoprophylaxis, or SMC) as recommended by the World Health Organization, but the 6-10-year-olds are not included in the program.  An effective vaccine would be the ideal solution.”

Dr. Hoffman added “the Mali trial builds on the results of prior studies where the product being tested, PfSPZ Vaccine, has shown significant protection against naturally transmitted Pf malaria in African adults, including women experiencing pregnancy, for whom Pf malaria is an especially dangerous infection. It’s time now to see if it works equally well in African children.”  PfSPZ Vaccine, which is composed of radiation-attenuated PfSPZ, is Sanaria’s first generation product. It has been tested in 22 prior trials.

Clinical trial in Indonesia

Like the trial in Mali, the trial in Indonesia is testing PfSPZ Vaccine, using the same regimen: 3 doses of PfSPZ administered over four weeks.  The Indonesia trial is concurrently testing a second generation PfSPZ vaccine, called PfSPZ-CVac (CQ).  “CVac” stands for chemoprophylaxis vaccine, describing the approach, which is to administer non-attenuated PfSPZ to humans, to allow the parasites to multiply briefly and then to kill them by co-administration of an antimalarial (“chemoprophylactic”) drug.  Because these PfSPZ are non-attenuated, they multiply harmlessly in the human liver, unlike PfSPZ Vaccine, which is unable to replicate itself, amplifying the amount of malaria protein, thereby giving the immune system a much stronger stimulus.  “PfSPZ-CVac (CQ) is many times more potent than PfSPZ Vaccine,” said Sanaria’s Chief Medical Officer, Dr. Thomas Richie. “We can achieve higher levels of protection using PfSPZ-CVac than we can with PfSPZ Vaccine, at just one fifth the dose.”  PfSPZ-CVac (CQ) is being administered as three doses over 8 weeks.

The Indonesian Army is especially interested in testing Sanaria’s vaccines because Pf malaria has been a significant cause of illness for soldiers during deployments.  Professor Amin, former Director of the Eijkman Institute for Molecular Biology in Jakarta, stated “we have succeeded in freeing much of Indonesia from malaria; however, there are areas, such as in the eastern provinces, where many species of malaria still circulate, creating a threat for the citizens as well as for deployed military personnel.  We will be very interested to see how well the Sanaria vaccines work, and to see if they provide cross-protection against the other species of malaria circulating there, such as Plasmodium vivax.”

The Indonesia trial is being performed as a collaboration between the Indonesian Army, the Eijkman Institute, the University of Indonesia School of Medicine, and the University of Oxford. Dr. Erni Nelwan, from the University of Indonesia, serves as lead investigator. The performing clinical team, led by Dr. Krisin Chand, is from the Eijkman-Oxford Clinical Research Unit (EOCRU), which is currently onsite working with Army medical officers to immunize the soldiers prior to deployment.

Both trials are randomized, double-blind, and placebo-controlled.  “This is the most powerful and objective way to assess our vaccines,” says Dr. Hoffman.  “We compare the vaccines to inert (salt water) placebo.” The Mali trial will be unblinded in the first or second quarter of 2023, and the Indonesia trial later that same year.  “By comparing malaria attack rates in vaccinees and controls, we can calculate the efficacy of the vaccine,” Dr. Hoffman explained.

Prof. Kevin Baird of Oxford University and the Director of EOCRU summed up hopes for the Sanaria vaccines: “Live sporozoite vaccine technologies have great promise as a tool of malaria elimination rather than mitigation. We hope these new trials will help demonstrate that and spur more rapid progress in their development.”

In addition to testing PfSPZ Vaccine (radiation-attenuated PfSPZ) and PfSPZ-CVac (chemo-attenuated PfSPZ), Sanaria and collaborators at the Seattle Children’s Research Institute are developing a third-generation vaccine, which is attenuated by the targeted deletion of genes needed for the parasite to transform from the benign liver stages to the deadly blood stages. This vaccine, called PfSPZ-LARC2 Vaccine, is slated to begin clinical testing later in 2022.

About Sanaria Inc.

Sanaria is a biotechnology company based in Rockville, Maryland (USA) that is developing whole parasite PfSPZ vaccines to protect against malaria. Sanaria's vaccines have been shown to be highly protective against Plasmodium infections in humans. Sanaria's vaccines will be used to prevent malaria in individuals and in combination with other malaria control measures to stop malaria transmission and eliminate malaria in defined geographic regions.

Forward Looking Statement

Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. Such statements include the availability of an effective vaccine, the expectations for conquering malaria, beliefs concerning the suitability of a successful vaccine, and the establishment of a path toward prevention of infection. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements.

For business information please email Alexander Hoffman at sanaria@sanaria.com, 301-339-0092.

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