GlycoVaxyn initiates Phase I clinical study of GVXN SD133 vaccine candidate against Shigella dysenteriae

GlycoVaxyn, a pioneer in the development of innovative bioconjugate vaccines, has commenced a Phase I clinical study with its vaccine candidate (GVXN SD133) against Shigella dysenteriae, a cause of serious intestinal infections. This is the first product from the company to enter clinical evaluation.

“The start of clinical trials with our first candidate marks a major milestone for GlycoVaxyn and will serve as validation of our bioconjugation platform”

The objective of this single-blind, first in human study is to evaluate safety, reactogenicity and immunogenicity of the vaccine at two doses, with or without adjuvant, in 40 healthy naïve volunteers. Data from the study are anticipated by the end of 2010.

A conjugate vaccine, used to immunize against serious bacterial infections, is created by linking a sugar antigen to a carrier protein molecule. The current process to obtain such a structure is often very complex, unreliable and expensive. GlycoVaxyn’s shigella vaccine consists of a polysaccharide of Shigella dysenteriae O1 conjugated to a protein carrier. It is produced using GlycoVaxyn’s novel technology that allows the synthesis of these complex immunogenic bioconjugates via a biological process in E. Coli, which makes the production more effective and controlled.

To obtain a broad protection against the disease, GlycoVaxyn is also actively developing a multivalent vaccine against Shigella flexneri serotypes and Shigella sonnei. Conjugate vaccines are largely used to prevent important diseases such as bacteremia (bloodstream infection) and meningitis, with the market leader achieving nearly USD 3 billion in annual sales.

“The start of clinical trials with our first candidate marks a major milestone for GlycoVaxyn and will serve as validation of our bioconjugation platform,” noted Philippe Dro, CEO of GlycoVaxyn. “There is a large demand for a shigella vaccine, particularly in emerging countries. Our proprietary technology allows us not only to develop and produce a multivalent shigella vaccine but also bioconjugate vaccines against various diseases where no prevention or treatment is available.”