NEWARK, Del.--(BUSINESS WIRE)--Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announced today that clearance was obtained from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND), Fraunhofer’s plant-derived malaria transmission-blocking vaccine (TBV), which targets the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety and immunogenicity study. Antibodies directed at Pfs25 can block transmission of the malaria parasite from mosquitoes to humans by preventing the parasite from developing in the mosquito. In preclinical models, purified plant-derived virus-like particles containing Pfs25, in combination with the adjuvant Alhydrogel®, have been shown to induce antibodies that effectively block infection of mosquitoes that have fed on an infectious blood meal. If these results can be reproduced in humans, the vaccine approach may provide a strategy to interrupt malaria transmission and thereby contribute to reduction of the P. falciparum disease burden.
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