Fraunhofer USA receives FDA clearance for IND malaria TBV that targets Pfs25 antigen

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.

"Entering this clinical trial is an important milestone," said Dr. Yusibov, Executive Director of FhCMB. "We have moved targets from molecular engineering all the way through to pilot scale manufacturing in plants under good manufacturing practices and evaluation in a Phase 1 clinical trial."

Development of this malaria TBV is an effort to improve global health by supporting the development of critical platform technologies for delivering vaccines to malaria-endemic countries. As part of the planned collaboration strategy, FhCMB, the PATH Malaria Vaccine Initiative (MVI) and Accelovance entered into an agreement to conduct a Phase 1 clinical trial.

"We are excited to see this promising new vaccine approach advance to clinical testing," says Ashley J. Birkett, PhD, Director of MVI. "Vaccines that can induce immunity to break the cycle malaria parasite transmission between humans and mosquitoes have the potential important interventions to accelerate future elimination and eradication efforts."

This Phase 1 clinical trial was initiated in early November and is being conducted by Accelovance.