Emergent BioSolutions Inc. has signed a license agreement with Coley Pharmaceutical Group Inc. for the use of Coley's proprietary VaxImmune vaccine adjuvant compound. Emergent intends to utilize VaxImmune in the development of new anthrax vaccines. Financial terms of the license agreement were not disclosed.
Coley's VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to infections in order to achieve and sustain a clinical response without compromising safety.
"As a leading developer of both biodefense and commercial vaccines and therapeutics, we continually assess novel adjuvant technologies as a critical component of our development strategy," stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "We believe that gaining access to a promising adjuvant technology like VaxImmune provides us a distinct advantage. This adjuvant has the potential to significantly enhance immune responses. Securing rights to VaxImmune demonstrates our commitment to developing our anthrax franchise, which includes BioThrax (Anthrax Vaccine Adsorbed), the only FDA licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax, an enhanced anthrax vaccine and an anthrax immune globulin (therapeutic)."
The agreement allows the company to build on promising data from a phase I clinical study funded by the defense advanced research projects agency (DARPA) of the DoD. This double-blind phase I clinical trial was designed to evaluate the safety and immunogenicity of a combined product candidate using BioThrax and VaxImmune compared to BioThrax alone and VaxImmune alone. This human trial, developed through collaboration among DARPA, Coley and Emergent BioSolutions, and completed in 2005, involved 69 healthy volunteers and used a three-dose regimen and intramuscular route of administration.
The immunogenicity results from this trial were promising. Specifically, the mean peak concentration of antibodies to anthrax protective antigen in participants who received BioThrax plus VaxImmune was approximately 6.3 times higher than in participants who received BioThrax alone. In addition, this mean peak concentration of antibodies to anthrax protective antigen was achieved in approximately three weeks after first injection in participants who received BioThrax plus VaxImmune, which is approximately 21 days sooner than in those participants who received BioThrax alone.