HELICOVAXOR® refers to a consortium of European pharmaceutical companies and research institutions that were brought together and funded under an European Community’s Seven Framework Programme.  The consortium came together in 2013 to work toward the goal of developing an oral vaccine against Helicobacter pylori, the leading cause of stomach ulcers and a proven factor in the development of gastric cancer.  The consortium was granted research funding from the European Community’s Seventh Framework Programme under grant agreement number 315640.  The consortium was brought together and was led by Sigmoid Pharma Ltd, a private company based in Ireland with a novel oral drug delivery technology; SmPill®.  Two other Small/Medium-Sized Enterprises (SMEs); Gotovax AB and Telormedix SA were lead members of the consortium. The consortium included a number of academic and commercial organisations who brought specific expertise and skills to certain aspects of the consortium’s workplan.  These organisations are referred to as RTD (Research, Technological development and Demonstration activities) participants and included Allied Automation Ltd., Particular Sciences Ltd., Almac Group Ltd., Diamond Pharma Services, Trinity College Dublin, University of Gothenburg Vaccine Research Institute, Corden Pharma, and MediTox (previously known as BioTest).

To develop an oral Helicobacter pylori vaccine the consortium evaluated the appropriate combination of antigen and adjuvant and presented the combination in a customised formulation.  Sigmoid, Gotovax and Telormedix each provided proprietary formulations, antigens and adjuvants respectively to achieve the goal of a Helicobacter pylori oral vaccine suitable for evaluation in human clinical trials.

An antigen is a substance that causes an immune response, specifically the production of antibodies. An adjuvant is substance that enhances the immune response to the antigen, thus improving the efficacy of the antigen as a vaccine.  Vaccines are often administered by injection, but developing an oral vaccine can offer substantial advantages including, but not limited to, patient convenience and reduced health care costs.

The consortium conducted preclinical development and testing, with a view to developing an oral vaccine prototype suitable for human clinical testing.  Specialist industry and academic groups provided expert capabilities and services to the HELICOVAXOR® consortium to complete the preclinical work.

The initial funding term has now concluded.  The consortium leaders continue to explore different aspects of the HELICOVAXOR® prototype.  The lead preclinical HELICOVAXOR® prototype showed significant promise but did not meet all of the criteria to advance directly to human clinical trials.  The consortium leaders are currently focused on:

- Scaling up the manufacturing process for the oral drug delivery technology, SmPill®

- Scaling up antigen production at Gotovax

- Accessing and further optimising adjuvant composition