Follow-on agreement will lead to clinical trials
The PATH Malaria Vaccine Initiative (MVI) and Inovio Pharmaceuticals have expanded their partnership to advance malaria vaccine development and new vaccination delivery technologies. Scientists will test whether a vaccine that combines genetically engineered DNA with a vaccine delivery technology called electroporation could induce an immune response in humans that protects against malaria.
This follow-on agreement for clinical development builds on a 2010 R&D partnership between Inovio and MVI in which they developed novel DNA plasmids targeting multiple malaria parasite antigens and conducted studies in rodents to demonstrate induction of broad immune responses. The success of these studies resulted in an expanded collaboration, in which further testing demonstrated potent T cell and antibody responses in other animal models.
The DNA-based vaccine approach involves delivery of plasmid DNA by electroporation, which deploys controlled electrical impulses to create temporary pores in a cell membrane, allowing uptake of the synthetic DNA. The cell then uses the DNA's instructions to produce proteins that mimic the presence of the malaria pathogen, with the aim of inducing an immune response that provides protection against malaria.
We are excited to work with our collaborators at MVI toward the ultimate goal of conquering malaria
There will be two arms to the clinical studies. The first will include three antigens, two pre-erythrocytic (CSP and TRAP) and one blood stage (AMA-1), shown previously to protect against Plasmodium falciparum, the most deadly malaria strain. The second will include two additional pre-erythrocytic-stage antigens (LSA-1 and CelTOS).
Joseph Kim, president and CEO of Inovio, said: ‘Our synthetic vaccine platform has produced vaccine candidates against HPV, HIV, and influenza targets that have generated potent T cell immune responses observed in human clinical studies. Using the same platform technology, we have now generated encouraging data with preclinical testing of our malaria antigen plasmids. We are excited to work with our collaborators at MVI toward the ultimate goal of conquering malaria.’
The Phase 1/2a clinical trial, which will begin early next year, will test Inovio's plasmid DNA and electroporation technology in 30 individuals, as part of a ‘challenge’ trial by controlled human malaria infection. Volunteers will be administered the DNA and then exposed to the malaria parasite through the bite of infected mosquitoes to see whether this approach prevents infection. If successful, this trial would provide valuable information that may further the development of a highly effective vaccine against malaria.