GlycoVaxyn announces the initiation of a Phase I clinical trial in collaboration with Janssen for a vaccine against Extra-intestinal pathogenic Escherichia coli causing urinary tract infection

ZURICH-SCHLIEREN, Switzerland, July 1, 2014 /PRNewswire/ -- GlycoVaxyn AG, a leader in the development of innovative conjugate vaccines, today announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs). The investigational vaccine is being co-developed by GlycoVaxyn AG and Janssen Pharmaceuticals Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The first-in-human clinical study includes 180 women affected by recurrent UTI. It is a multicenter, placebo-controlled study conducted in Switzerland. The primary aim is to assess the safety of the candidate vaccine. In addition, the immunogenicity, measured by the induction of bactericidal (opsonophagocytic) antibodies, will be determined. Finally, the serotype-specific efficacy of the vaccine will be evaluated. The glycoconjugate ExPEC vaccine was produced using GlycoVaxyn's proprietary biological conjugation platform and contains surface polysaccharide antigens of the most predominant ExPEC strains.

Urinary tract infection (UTI) is the most common urological disease and one of the most frequent bacterial infections. Up to 50% of all women experience at least one UTI and 10-15% have recurrent UTI, which is a significant clinical problem in terms of morbidity, ongoing medical care, and associated health care costs. ExPEC bacteria cause 80% of community-acquired UTIs and approximately 50% of hospital-acquired UTIs. Increasing resistance to antibiotics among ExPEC strains thereby reducing the efficacy of treatment emphasizes the need to develop preventative measures.

ExPEC bacteria are also a leading cause of invasive E.coli infectious diseases such as bacteremia, an increasing problem in the aging population and partly linked to increasing antibiotic resistance.

"We are very excited and proud to have initiated this trial within a very short period of time following our announced collaboration with Janssen and we believe that such a vaccine will bring important health benefits to patients who are chronically affected by this infection," said Dr. Veronica Gambillara, Head of Clinical and Regulatory affairs at GlycoVaxyn.

GlycoVaxyn's biological conjugation platform enables the enzymatic conjugation of antigenic polysaccharides to protein carriers and therefore makes the development and commercialization of complex multivalent vaccines easier, faster and more reliable.

About GlycoVaxyn AG

GlycoVaxyn is a privately-funded company developing a portfolio of novel bio-conjugate vaccines against common severe bacterial infections produced with its unique, proprietary in vivo glycosylation platform. With this platform, the company can develop and produce immunogenic glycoprotein conjugates in a biological process that circumvents many of the challenges and uncertainties involved in currently used chemical methods. In addition, the biological conjugation of polysaccharide antigens to homologous protein antigens may broaden the coverage of the vaccine. GlycoVaxyn has secured funding from the Wellcome Trust for its multivalent Shigella vaccine that is expected to enter further clinical development next year. A novel tetravalent vaccine aimed at the prevention of Staphylococcus aureus infection as well as a multivalent Streptococcus pneumoniae vaccine are under development and have shown promising preclinical results. GlycoVaxyn is collaborating with GlaxoSmithKline and Janssen for the development of several vaccine candidates. GlycoVaxyn is funded by a top-tier group of private investors including Sofinnova Partners, Index Ventures and Edmond de Rothschild Investment Partners.  For further information, visit www.glycovaxyn.com.

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