FhCMB announces FDA approval for Clinical 1 trial of anti-malarial vaccine

Fraunhofer USA Center for Molecular Biotechnology announced on Wednesday that it received clearance from the U.S. Food and Drug Administration to begin a Phase 1 safety and immunogenicity study for its new anti-malarial drug.

The new investigational drug is plant-based and targets the Pfs25 antigen. The vaccine directs antibodies at Pfs25 antigens to prevent the P. falciparum malaria parasite from developing in mosquitoes, which can prevent the disease from being transmitted to humans.

In preclinical studies, plant-based virus-like particles containing Pfs25 and the Alhydrogel adjuvant showed effectiveness in preventing infection in mosquitoes that were fed an infectious blood meal. The research team hopes to produce the same response in humans to provide a wide-scale solution to malaria infection globally.

"Entering this clinical trial is an important milestone," FhCMB Executive Director Dr. Yusibov said. "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."

The research team hopes to develop the vaccine as an effective method to combat malaria in endemic countries. The Phase 1 clinical trial is a part of the combined FhCMB, PATH Malaria Vaccine Initiative and Accelovance initiative.

"We are excited to see this promising new vaccine approach advance to clinical testing," MVI Director Ashley J. Birkett said. "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."