Prokarium has announced an investment of £4.59 million from Wellcome to fund two clinical trials of its lead programme, Entervax.
The bivalent vaccine against enteric fever is based on the Vaxonella platform and is the combination of Prokarium’s proprietary strain ZH9 (Salmonella enterica serovar Typhi ZH9), which has been safely administered to 351 individuals including 101 children in the UK, US and Vietnam, plus a novel strain modified to express antigens specific to SalmonellaParatyphi A.
The company has announced that the funding from Wellcome will be used for a Phase I study in the UK and a Phase Ib age-descending, dose-escalation study in an endemic region in South Asia. It also confirmed that the Phase I study is a randomised, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of the bivalent vaccine, and that the company plans to initiate dosing in the first half 2020.
“Funding from a prestigious foundation such as the Wellcome Trust underlines the strength of our approach and provides the support necessary to progress to the clinic,” said Ted Fjallman, chief executive officer, Prokarium. “Entervax performed as expected in the preclinical and nonclinical models and we look forward to building on the results we observed previously with our monovalent typhoid vaccine candidate, ZH9.
“Our oral vaccine candidate being developed for the prevention of enteric fever could provide a significant public health benefit for these at-risk populations in endemic regions and beyond.”
Enteric fever, a preventable illness caused by Salmonella enterica serovars Typhi and Paratyphi, is the most common bacterial bloodstream infection in South Asia. Despite progress being made in controlling enteric fever in several parts of the world, it remains an important public health burden in South Asia and Africa and has been estimated to cause more than 15 million illnesses and nearly 153,000 deaths worldwide annually.