LONDON, UK – Prokarium, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received today the Clinical Trial Authorization (CTA) acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a first-in-human Phase I trial with Entervax™, a bivalent vaccine against Enteric fever. Prokarium anticipates dosing of the first subject to begin in the first quarter of 2020.
The trial is part of a collaboration between Prokarium and the Wellcome Trust, who invested £4.6M earlier this year to fund two clinical trials with Entervax™. The first trial, now accepted by the MHRA, is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of Entervax™ in healthy volunteers.
“The acceptance of the Entervax™ CTA is additional validation of our vaccine candidate and underlying technology” said Ted Fjallman, Ph.D, Chief Executive Officer, Prokarium, “it also brings Entervax™ one step closer to those who need it.” The endemic population in low- and middle-income countries (LMICs) is about 5.6 billion of which 1.6 billion are at high-risk of developing a typhoid infection. This is complicated by the spread of extensively drug resistant (XDR) strains which is creating a global need for new vaccines and Entervax™ has the potential to provide broader protection for these at-risk individuals in LMICs and travellers to those countries. Following this Phase I trial, Prokarium plans to run a Phase Ib age-descending, dose-escalation study in South Asia.
