- The UK HVC awards GENEART a contract on designing and producing a DNA vaccine mix against HIV
- Genes delivered are to be used as basis for subsequent clinical studies
- DIN EN ISO 9001:2000 certification and GENEART’s comprehensive documentation provide optimal conditions for approval process
- Gene synthesis and gene design are considered gold standard for the development of vaccines
Regensburg, June 19, 2009 – GENEART AG, global leader in gene synthesis and specialist in the field of Synthetic Biology, announces being awarded a contract for the design and production of two DNA vaccine candidates against HIV by the UK HVC. The genes (blueprints for virus proteins), optimized and customized by GENEART, are to be used as basis for clinical studies.
Two gene constructs, developed by GENEART in cooperation with the Institute of Medical Microbiology and Hygiene at the University of Regensburg, are currently being evaluated at Clinical Phase I/II under the umbrella of the European research syndicate EuroVacc, since Phase I results were promising. The genes ordered by the UK HVC are based on a different HIV isolate but rest on the same concept as the gene constructs already used in clinical studies. Blueprints of selected proteins of the HIV virus are modified using GENEART’s proprietary GeneOptimizer® Software such that they can be produced with maximal yield and therefore most efficiently, triggering an optimal immune response but at the same time losing their toxic capacity, thus contributing to an increased safety profile. GENEART will not only provide the respective genes, but will in addition – as an extension of the value chain – analyze and ensure the producibility of the resulting proteins in cell cultures (Expression Proof).
The UK HVC does not only benefit from the rational design of the respective genes or virus proteins but also from a production in accordance with DIN EN ISO 9001:2000 as well as a documentation of the production process. Thereby, GENEART provides ideal conditions for the subsequent approval process. “This order shows once again how we established both gene design and gene synthesis as the gold standard for the development of vaccines. Customers benefit from optimal properties with respect to immune response and safety due to maximal design flexibility during the development of vaccines”, said Prof. Dr. Ralf Wagner, CEO and CSO of GENEART.
This document may contain estimates, prognoses and opinions about company plans and objectives, products or services, future results, opinions about these results or opinions leading up to these results. All these projections into the future are subject to risk, uncertainty and unforeseeable change outside the control of the GENEART Group. Many factors may lead to actual results, which considerably deviate from the given projections for these results.
About the UK HVC
The UK HIV Vaccine Consortium is an integrated and project-managed collaboration between Imperial College London, St George’s University London, University of Oxford, Royal Holloway – London University, IAVI and the Medical Research Council (Clinical Trials Unit) supported by a strategic award from the Wellcome Trust. The aim of the consortium is to study diverse potential HIV vaccine constructs and immunization strategies. Its overarching strategy is the comparative clinical study of GMP products bearing common HIV inserts, using short schedule, small scale clinical trials in healthy volunteers. The UK HVC acts as a “hub” providing GMP vaccines under the terms and conditions of the UK HVC Access Strategy to academic groups called “spokes”. Approved spokes apply for funding for clinical trials with the support of the UK HVC without having to bear the cost of vaccines production. The UK HVC is strategically important, as it will gain the maximum added value from independent research projects currently funded from diverse sources. It will allow data on the direct comparison of diverse immunogens and strategies to be reported in a timely manner to inform the choice of constructs for wider testing and is highly relevant internationally as a contributor to the Global HIV Vaccine Enterprise (GHAVE).
About the Wellcome Trust
The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending over £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.
About GENEART AG
In 2000 GENEART entered the Gene Synthesis market and has since become the global market leader. Today, the company is one of the leading specialists in the Synthetic Biology field. Experts at GENEART provide key technologies for the development and production of new therapeutics and vaccines. Customers also take advantage of GENEART services to customize enzyme attributes, such as the attributes of enzymes used as detergent additives, and to construct bacteria, which produce complex biopolymers or break down polymers, such as synthetics, petroleum components, etc. GENEART’s service portfolio ranges from the optimization and production of synthetic genes according to DIN EN ISO 9001:2008, to the generation of gene variants or complex gene libraries and the production of cell lines, to the development and production of DNA and protein based drug candidates. GENEART AG in Regensburg and its subsidiaries GENEART Inc. in Toronto (Canada) and GENEART Inc. in San Francisco (USA) employ about 180 people. The company is listed on the German Stock Exchange since May 2006. Since April 2010, the US-American Life Technologies Corporation, one of the leading biotechnology companies worldwide with 2009 revenues of 3.3B U.S. dollars and about 9,000 employees, is majority shareholder of GENEART AG.