Pharmaceutical Business review

Themis begins phase 1 trial of MV-LASV Lassa fever vaccine candidate

Themis initiates phase 1 trial of MV-LASV Lassa fever vaccine candidate. Photo: courtesy of Liz Masoner from Pixabay.

The Austrian biotech company is partnering with the Coalition for Epidemic Preparedness Innovations (CEPI) for the development of the MV-LASV Lassa fever vaccine candidate.

The phase 1 trial for MV-LASV is a randomised, placebo-controlled, dose-finding study, which will have 60 healthy adult participants.

The early-stage clinical trial is being held by the Centre for the Evaluation of Vaccination in Antwerp, Belgium. It will assess the safety, tolerability and immunogenicity of MV-LASV after administration of two different dose levels.

Themis CEO Erich Tauber said: “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.

“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.”

Also known as Lassa hemorrhagic fever, Lassa fever is caused by a virus of the same name which is transmitted to humans through contact with food or household items that are contaminated with rat urine or feces.

Currently, there are no vaccines that give protection against Lassa fever. Symptoms of the condition are vomiting, face swelling, bleeding, and pain in the chest, abdomen, and back.

The MV-LASV vaccine candidate has been developed based on Themis’ measles vector platform and exclusively-licensed discoveries made at Institut Pasteur.

The investigational vaccine is a recombinant, live attenuated, viral vectored vaccine. It is based on the backbone of the measles Schwarz virus strain.

The vaccine programme is funded by a global partnership forged by Themis with CEPI that will support the development of the MV-LASV vaccine candidate until the end of phase 2. According to Themis, the phase 2 programme of the vaccine candidate is designed to generate clinical safety and immunological data.

CEPI vaccine development director Melanie Saville said: “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.”