Aeras and the Infectious Disease Research Institute (IDRI) announce today a new agreement to conduct joint development activities with respect to IDRI's novel tuberculosis vaccine candidate. This collaboration reflects the missions of the two non-profit product development partnerships to use cutting-edge science to develop products that address critical diseases of underserved populations around the world, including tuberculosis.
"Tuberculosis is one of the most widespread, persistent and deadly global health problems," said Dr. Steven Reed, IDRI founder and Chief Scientific Officer, who has led many years of developing the vaccine. "Given Aeras' focus and breadth of experience in supporting the clinical development of tuberculosis vaccines, we believe this collaboration will speed the development of this promising new vaccine."
According to the World Health Organization (WHO), one-third of the world's population is infected with latent TB, and 1.4 million people died from TB in 2010. The current TB vaccine, Bacille Calmette-Gu-rin (BCG), developed 90 years ago, reduces the risk of severe forms of TB in early childhood but has been ineffective in controlling the global TB epidemic despite widespread use.
IDRI's vaccine candidate, ID93/GLA-SE, is composed of an IDRI designed recombinant fusion-protein antigen plus IDRI's proprietary adjuvant, GLA, which has been previously tested in humans, but has not been used in any other TB vaccine currently in clinical development. The vaccine candidate targets both active tuberculosis, which affects nearly 9 million people each year, and latent TB, which lies dormant but can make people sick when their immune systems are compromised. IDRI anticipates that the vaccine may be used to protect individuals prophylactically, with or without BCG vaccination, or therapeutically in combination with anti-tuberculosis drugs in patients with active infection.
An Investigational New Drug filing has been submitted to the US Food and Drug Administration, and pending review, a Phase I clinical trial to evaluate the safety and immunogenicity of ID93/GLA-SE in a group of healthy volunteers will start later this year.
"Aeras is pleased to collaborate in the clinical development of this promising tuberculosis vaccine candidate," said Jim Connolly, President and CEO of Aeras. "We look forward to sharing resources and expertise with a like-minded organization also committed to saving the lives and livelihoods of the millions of people who will otherwise succumb to this devastating disease."
In pre-clinical studies, ID93/GLA-SE had an acceptable safety profile in animals and demonstrated substantial protection against Mycobacterium tuberculosis - the bacterium that causes tuberculosis - both with and without previous priming with BCG.
Both Aeras and IDRI are committed to ensuring that new TB vaccines developed under this partnership will be accessible and affordable to those who need them most in developing countries.
The path to a better tuberculosis vaccine runs through Montana