Themis Bioscience and CEPI Announce Initiation of Phase 1 Clinical Trial with Lassa Fever Vaccine
Themis Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI) announced today the first administration to healthy volunteers in a Phase 1 clinical trial wth Themis’ vaccine candidate against Lassa fever. The MV-LASV Lassa fever vaccine candidate, is based on Themis’ proprietary measles vector platform and exclusively-licensed discoveries made at Institut Pasteur. The MV-LASV Lassa fever vaccine program is funded through a global partnership with CEPI that will support the candidate vaccine’s development up to the end of Phase 2, which is designed to provide clinical safety and immunological data. The investment, which was the first in CEPI’s portfolio, will also help establish investigational stockpiles of Themis’ vaccine candidate that will be ready for clinical efficacy trial testing during outbreaks.
“Themis’ versatile technology platform and our ability to rapidly advance candidates into the clinic has been demonstrated previously through the discovery, development and production of a Phase 3-ready vaccine candidate against Chikungunya as well as our recently announced trial for a novel Zika vaccine,” commented Erich Tauber, MD, CEO of Themis. “Our partnership with CEPI for Lassa fever further validates our capabilities and represents our combined commitment to tackle diseases that remain a public health threat globally.”
Dr. Melanie Saville, Director of Vaccine Development at CEPI added: “Themis was the first company CEPI partnered with to develop a vaccine against Lassa fever and MERS, two of our priority pathogens. Lassa fever remains a serious public health threat across West Africa, with Nigeria alone experiencing its largest ever outbreak of the disease this year1. This first in-human trial for Themis’ MV-LASV Lassa candidate is an important first step in its evaluation in the clinic and toward developing an effective vaccine which will be available to at-risk populations during outbreaks of this deadly emerging infectious disease.”
The MV-LASV vaccine candidate is a recombinant, live attenuated, viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection. The Phase 1 trial with MV-LASV is a randomized, placebo-controlled, dose-finding study in 60 healthy adult participants to investigate the safety, tolerability and immunogenicity of MV-LASV after administration of two different dose levels. The study, sponsored and led by Themis, is being conducted by the Centre for the Evaluation of Vaccination in Antwerp, Belgium, under the direction of Pierre Van Damme, MD, PhD, Professor at the University of Antwerp, Faculty of Medicine and Health Sciences. More information about the trial can be obtained using the ClinicalTrials.gov Identifier, NCT04055454.