Sanofi and GlaxoSmithKline have begun enrolling participants into a Phase III clinical study of their adjuvanted recombinant-protein Covid-19 vaccine candidate. The global randomised, double-blinded, placebo-controlled study will include about 35,000 volunteers aged 18 years and older from different countries, including sites in Asia, Africa, the US and Latin America. The study will assess vaccine formulations targeting the original D.614 virus and the B.1.351 variant across geographies. A booster trial is likely to begin in the coming weeks, with the vaccine expected to be approved by the end of 2021.
Novartis and Switzerland-based biopharma Molecular Partners have commenced the EMPATHY clinical trial, a Phase II and III study exploring the use of its DARPin therapeutic candidate ensovibep (MP0420) for treating Covid-19. Novartis is expected to conduct the clinical trial programme, with Molecular Partners as sponsor of the trials. Molecular Partners reported positive results from its initial Phase I trial of ensovibep in healthy individuals in March 2021. EMPATHY will enrol 2,100 patients across the two studies, with the aim of preventing the severity of the disease and hospitalisation.
Swiss biotechnology company ACM Biosciences has received a grant from Innosuisse, the Swiss Innovation Agency, to collaborate and develop a novel delivery system for mRNA Covid-19 vaccines. Dr Steve Pascolo, an mRNA vaccines expert at the University Hospital Zurich, will partner with ACM Biosciences to develop a new stable carrier for mRNA with improvements to the flexibility, logistics, and refrigeration of the vaccines.