Malaria, Falciparum

HDT Bio’s LION ™ platform to support malaria vaccine development by MalarVx SEATTLE, WA, USA I January 15, 2025 I MalarVx, Inc., a clinical-stage vaccine company, is proud to announce a license to HDT Bio’s proprietary self-amplifying replicon RNA (repRNA) and lipid nanoparticle (LION™) technologies for use in malaria vaccines. In addition to HDT Bio’s technologies, the agreement provides MalarVx additional support from HDT to develop and commercialize malaria vaccines. This license expands the long-standing relationship between the parties. Malaria was responsible for 597,000 deaths and 263 million cases in 2023, according to the World Health Organization. Despite the expenditure of $4 billion per year on control 1 , malaria deaths and cases have not substantively changed over the last decade. Consequently, a safe, effective, long-lasting, easy-to-use, and cost-effective vaccine to prevent malaria is desperately needed. HDT Bio Corp. is a clinical-stage biopharmaceutical company specializing in advanced RNA vaccine technologies, including the company’s proprietary LION nanoparticle delivery system. LION is well-suited for use in vaccines to prevent viral and bacterial infections. “We are excited to contribute our expertise in RNA vaccine technologies in an effort to develop malaria vaccines with MalarVx,” said Steve Reed, Ph.D., CEO of HDT Bio. “Our LION platform has a demonstrated ability to rapidly generate potent, durable immune responses with a favorable safety profile.” “This collaboration is an example of our aspiration to enable a new generation of global health technologies,” said Curt Malloy, HDT SVP Strategic Operations.  “We are dedicated to applying our technology to address critical global health challenges. From combating infectious diseases like malaria to pioneering breakthroughs in cancer prevention and treatment, we remain committed to catalyzing innovations that address unmet global health needs.” MalarVx has also demonstrated the potential of LION-based vaccines to prevent infections caused by Plasmodium parasites, the pathogens responsible for malaria in humans and other animals. “We believe the attributes of LION-based vaccines, including increased potency, product stability, and simplified manufacturing, are essential for vaccines designed for use in resource limited environments,” said James Davie, MalarVx CEO. “Of particular interest is the potential for a multi-species vaccine capable of preventing Plasmodium falciparum and Plasmodium vivax infections, since these pathogens are responsible for most cases of malaria in humans.” Dr. Marion Avril, Ph.D., MalarVx Program Director, added, “We recognize the transformative potential of our vaccines to combat one of humanity’s most devastating diseases. Our collaboration with HDT Bio is a significant step towards achieving a world free from malaria. Together, we are committed to advancing innovative solutions that will save lives and improve health outcomes for millions of people globally.” About MalarVx MalarVx is a Seattle-based clinical-stage biopharmaceutical company developing vaccines to prevent malaria. Current efforts focus on the clinical development of a replicon RNA-based vaccine for the prevention of Plasmodium falciparum infection and on culturing the mosquito stages of the parasite for the cost-effective production of whole organism vaccines. For more information on MalarVx and its work on safe and effective malaria vaccines, visit www.malarvx.com About HDT Bio HDT Bio is a Seattle-based, clinical-stage biopharmaceutical development company. With core technology and expertise in nucleic acid formulation, the company develops products that seek to harness host-directed immune responses. HDT Bio’s work focuses on infectious disease and oncology vaccines and therapeutics through early-stage collaborations with partners worldwide. The company’s vaccine platforms combine formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses. HDT Bio’s repRNA/LION™ was the first self-amplifying RNA vaccine platform to receive regulatory authorization. For more information on HDT Bio platforms, visit www.hdt.bio 1 “Malaria Cases Up Again in 2023, African Children Worst Hit, WHO Reports.” Reuters, December 11, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/malaria-cases-up-again-2023-african-children-worst-hit-who-reports-2024-12-11/ . SOURCE: MalarVx; HDT Bio

A World Health Organization (WHO) study has listed the top endemic pathogens for which new vaccines are “urgently needed”. The study details the 17 pathogens that regularly cause diseases in communities and represents the first global effort to “systematically prioritise” endemic pathogens based on criteria such as antimicrobial resistance risk, regional disease burden and socioeconomic impact, WHO said. Alongside reconfirming long-standing priorities for vaccine research and development, including for malaria and HIV, the study also identifies pathogens such as Group A streptococcus and Klebsiella pneumoniae as top disease control priorities in all regions. Kate O’Brien, director of the immunisation, vaccines and biologicals department at WHO, said: “Too often global decisions on new vaccines have been solely driven by return on investment, rather than by the number of lives that could be saved in the most vulnerable communities. “This study uses broad regional expertise and data to assess vaccines that would not only significantly reduce diseases that greatly impact communities today but also reduce the medical costs that families and health systems face.” Vaccines for the 17 pathogens are at different stages of development, WHO outlined, with Group A streptococcus, hepatitis C virus, HIV-1 and Klebsiella pneumoniae on the list of pathogens where vaccine research is needed. The list of pathogens where vaccines need to be further developed includes Cytomegalovirus, influenza virus (broadly protective vaccine), Leishmania species, non-typhoidal Salmonella, Norovirus, Plasmodium falciparum (malaria), Shigella species and Staphylococcus aureus. Meanwhile, the pathogens where vaccines are approaching regulatory approval, policy recommendation or introduction are dengue virus, Group B streptococcus, extra-intestinal pathogenic E. coli, Mycobacterium tuberculosis and respiratory syncytial virus. The announcement comes just a few months after WHO released its 2024 Bacterial Priority Pathogens List, which highlights the antibiotic-resistant bacterial pathogens that should be prioritised to address the evolving challenges of antibiotic resistance, recognised as one of the biggest threats to public health globally. The updated list covers 24 pathogens spanning 15 families and categorises them into critical, high and medium priority groups to inform research and development and public health interventions.

On August 14th, 2024, The Lancet Infectious Diseases released a publication entitled: "Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials."Read More In a report published on March 21, 2024 in EMBO Molecular Medicine (A replication competent Plasmodium falciparum parasite completely attenuated by dual gene deletion) investigators at Seattle Children’s Research Institute and Sanaria Inc. describe the development of a whole malaria parasite vaccine strain that infects the liver, develops to the late liver stage, and then gets completely stuck and cannot burst out of the liver to cause symptomatic blood infection.Read More Sanaria receives $1.5M from the Gates Foundation to make PfSPZ Challenge more accessible for future controlled human malaria infections (CHMIs) in the form of a repository.Read More Scientists from Sanaria Inc., and collaborators at multiple institutions publish results in Nature reporting “In vitro production of infectious Plasmodium falciparum sporozoites.”Read More ROCKVILLE, MD, USA – July 12, 2022 – Sanaria Inc., University of Maryland School of Medicine, Naval Medical Research Center, National Institutes of Health (USA), University of Bamako Malaria Research and Training Center (Mali), and University of Tübingen (Germany) published results in Nature Communications showing Plasmodium falciparum 7G8 human challenge trials provide a conservative prediction of efficacy of PfNF54-based PfSPZ Vaccine in Africa.Read More Sanaria Inc. announces 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.Read More Sanaria Inc. and Seattle Children’s Research Institute are proud to announce the signing of an agreement to collaborate on the development and commercialization of next generation PfSPZ vaccines attenuated by genetic engineering.Read More In an article published today in Nature, Sanaria’s PfSPZ-CVac (CQ) vaccine is reported as being safe and protecting 100% of six subjects against a variant malaria parasite three months after their last dose in the company’s Phase 1 safety and efficacy trial. This is the first time complete protection against a variant malaria parasite has ever been achieved that long after vaccine administration.Read More Sanaria and its collaborators have had to take a step by step empirical approach to optimizing immunization with PfSPZ vaccines to achieve a safe, effective, durable, and broadly protective malaria vaccine. Two recent landmark malaria vaccine studies have moved the optimization process forward and highlighted the strong protective efficacy of Sanaria® PfSPZ-CVac in malaria-naïve adults. Read More Sanaria to receive €12.9M for the development of two Malaria vaccines, one Malaria prophylactic, and a SARS-CoV-2 vaccine from the EU Malaria Fund.Read More USPTO awards Sanaria with the 2020 Patents for Humanity Award for Sanaria's malaria vaccine.Read More Sanaria Inc. and the Government of Equatorial Guinea last week signed an agreement that continues their joint commitment to develop Sanaria® PfSPZ Vaccine as a tool for malaria elimination. This follows a new, broader agreement between the Government of Equatorial Guinea (EG) and industry partners, Marathon Oil Corporation, Noble Energy Inc. and Atlantic Methanol Production Company (AMPCO), to sponsor clinical development of Sanaria® PfSPZ Vaccine, including the Phase 3 clinical program starting in 2020. This long standing, successful partnership highlights the unique involvement of an African government and private-sector energy companies in developing a vaccine for a largely African problem.Read More Building upon publication of clinical trial results in Nature, PNAS, Lancet Infectious Diseases, and JCI Insight in 2017, Sanaria Inc. is highlighting the work of its many collaborators at a symposium entitled “Moving Toward a PfSPZ Malaria Vaccine for Protecting Travelers and Use in Elimination Campaigns” (session 133) at the 66th meeting of the American Society of Tropical Medicine and Hygiene in Baltimore, and then at the second 2017 International PfSPZ Consortium meeting held at the University of Maryland School of Medicine.Read More In a report published today in the Proceedings of the National Academy of Sciences, investigators from the National Institute of Allergy and Infectious Diseases (NIAID), NIH and the University of Maryland School of Medicine reported that nine of fourteen subjects (64%) immunized with three doses of Sanaria® PfSPZ Vaccine were protected against homologous challenge with Plasmodium falciparum malaria 19 weeks after their last vaccine dose. Moreover, five of six of the protected subjects who underwent a subsequent heterologous challenge with Plasmodium falciparum 33 weeks after their last vaccine dose were protected.Read More In a report published today in The Lancet Infectious Diseases, investigators reported that Sanaria® PfSPZ Vaccine protected against natural infections of Plasmodium falciparum, the leading cause of malaria deaths and that protection was sustained for the 24 weeks of the study in an area of intense malaria transmission.Read More In a report published today in Nature, investigators from the University of Tübingen reported all nine subjects (100%) immunized with three doses of Sanaria® PfSPZ-CVac malaria vaccine in a recently completed clinical trial were protected against Plasmodium falciparum malaria when exposed to the disease 10 weeks after last vaccine dose. Professor Peter Kremsner, MD, Director of the Institute of Tropical Medicine at the University, led the clinical team.Read More Sanaria Inc. continues to achieve success in its coordinated efforts to develop a safe, effective and affordable vaccine that delivers mass malaria protection in humans and promotes elimination of the disease worldwide. Research published today in JCI Insight by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research reports that Sanaria® PfSPZ Vaccine protected against Plasmodium falciparum malaria when clinical trial participants were exposed to two strains of parasites.Read More Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine. Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.Read More Results of a clinical trial of Sanaria® PfSPZ (Plasmodium falciparum sporozoite) Vaccine to prevent malaria infections, published today in the online issue of Nature Medicine magazine, show that the vaccine provided protection against infection with malaria parasites for at least 14 months in subjects who were exposed to Plasmodium falciparum parasites. The findings put the Sanaria vaccine on track to be the first malaria vaccine providing durable protection against infection with malaria parasites. Plasmodium falciparum is the malaria parasite that causes about 438,000 deaths and 214 million cases annually.Read More The Government of the Republic of Equatorial Guinea announced an agreement with industry partners, Marathon Oil Corporation, Noble Energy Inc. and AMPCO, to sponsor the clinical development of Sanaria® PfSPZ Vaccine against malaria, including a series of clinical trials from 2015 until 2018.Read More