Feb 23 2010
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.”
SOURCE GlycoVaxyn