LONDON--(BUSINESS WIRE)--Prokarium, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received 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, which invested £4.6m earlier this year to fund two clinical trials with Entervax™. The MHRA approved trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of Entervax™ in healthy volunteers.
“The Entervax™ CTA is additional validation of our vaccine candidate and underlying technology. Importantly, it brings Entervax™ one step closer to those who need it” said Prokarium’s CEO Ted Fjallman, Ph.D. 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 an extensively drug resistant (XDR) strain which is creating a growing global demand for new vaccines. 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.
Notes to Editors
About Enteric Fever
Enteric fever, a preventable illness caused predominantly by Salmonella enterica serovars Typhi and Paratyphi A, accounts for at least 20 million cases (range 10.8–43.3 million) annually and is the most common bacterial bloodstream infection in South Asia. Misdiagnoses and lack of efficacy of first-line treatments have led to an outbreak of extensively drug resistant strains and vaccination is the most effective medical intervention to stop the spread of the disease.
Entervax™ is an oral, bivalent vaccine based on the Vaxonella® platform and is the combination of Prokarium’s proprietary strain ZH9 (Salmonella enterica serovar Typhi ZH9), which has been safely studied in clinical trials in the UK, USA and Vietnam as a live oral vaccine for typhoid fever, plus a novel strain modified to express antigens specific to S. Paratyphi A.
Prokarium, a venture-backed biotechnology company, is a developer of targeted vaccines against infectious diseases. Its lead candidate is Entervax™, a vaccine against enteric fever, and the Company is also developing vaccines against Chlamydia trachomatis and Yersinia pestis, the latter being developed with the UK government. Prokarium is also investigating the use of its Salmonella platform as microbial immunotherapy for the treatment of solid tumors.