Promising Phase I interim data for ExPEC vaccine program triggers first milestone payment in clinical co-development with Janssen

Zurich-Schlieren, Switzerland, January 21, 2015 - GlycoVaxyn, a leader in the development of innovative conjugate vaccines, today announced that it has received the first milestone in its clinical co-development with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, of the vaccine candidate aimed to prevent infections caused by Extraintestinal Pathogenic Escherichia coli (ExPEC or E. coli).
The clinical milestone is linked to the achievement of a robust immune-response against all antigens included into the vaccine candidate at 30 days post-vaccination. ExPEC bacteria are a leading cause of adult bacteremia, an increasing problem in the aging population and partly linked to increasing antibiotic resistance. The induction of bactericidal (opsonophagocytic) antibodies, a well-known protective mechanism against bacteremia, is being measured in the ongoing clinical study. The first-in-human, placebo-controlled, randomized multicenter study currently conducted in Switzerland includes 194 women affected by recurrent urinary tract infections (UTIs). The primary aim is to assess the safety and immunogenicity of the vaccine candidate, including the measurement of bactericidal antibodies.
“We are excited about the achievement of this clinical milestone in our collaboration with Janssen. This underlines the ability of GlycoVaxyn’s versatile bioconjugation platform to generate novel vaccine candidates, which elicit a robust antibody response. The interim results validate our technology and ability to achieve clinical proof of mechanism within a very short period of time. We believe that the ExPEC vaccine has the potential to become a major breakthrough, mainly against the life-threatening antibiotic resistant ExPEC strains causing bacteremia,” said Dr. Michael Wacker, Chief Scientific Officer at GlycoVaxyn.
GlycoVaxyn’s versatile, propietary bioconjugation platform enables the conjugation of antigenic polysaccharides to protein carriers and makes the development of complex multivalent vaccines easier, faster and more reliable. Conjugate vaccines have been successfully used over the last four decades to prevent bacterial infections like meningitis and pneumonia and conjugate vaccines account for more than 30% of annual vaccines sales. An ExPEC vaccine is wanted since long and the novel bioconjugation technology can make it possible to prevent adult E.coli bacteremia.

About GlycoVaxyn
GlycoVaxyn AG was incorporated in 2004 in Zurich as a spin-off from the ETH Zurich, Switzerland. The privately-funded company is focused on the development of nextgeneration bioconjugate vaccines against bacterial infections, utilizing its versatile and innovative bioconjugation platform. With its 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. GlycoVaxyn has a broad pipeline of several bioconjugate vaccine candidates. The pipeline consists of partnered development programs with GlaxoSmithKline and Janssen Pharmaceuticals as well as proprietary programs. The latter includes a tetravalent vaccine aimed to prevent Staphylococcus aureus infections as well as a multivalent Streptococcus pneumoniae vaccine with promising preclinical results, and other programs including a multivalent vaccine candidate targeting several Shigella strains, where the company as secured funding from the Wellcome Trust. GlycoVaxyn has raised approximately CHF 50 million of equity funding and has top-tier private investors including Sofinnova Partners, Index Ventures and Edmond de Rothschild Investment Partners as key shareholders. For further information, visit www.glycovaxyn.com.

Contacts

Company contact: Media contact:
GlycoVaxyn Daniel Piller, Partner
Phone: +41 44 733 85 85 IRF Communications
media@glycovaxyn.com Phone: +41 43 244 81 54
daniel.piller@irfcom.ch