IDRI forges partnership with Aeras for development of new TB vaccine
Aeras and the Infectious Disease Research Institute (IDRI) Wednesday entered a pact for jointly conducting development activities connected with Seattle based IDRI's novel tuberculosis vaccine candidate.
The two non-profit product development partnerships hope 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.
"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," said Reed in a statement.
With funding from the Bill Melinda Gates Foundation, other private foundations, and governments, Aeras has invented or is supporting the development of six TB vaccine candidates, five of which are undergoing Phase I and Phase II clinical testing in Africa, Asia, North America and Europe.
Based in Rockville, Maryland, Aeras operates a state-of-the-art manufacturing and laboratory facility in the US and Cape Town, South Africa.
An Investigational New Drug filing has been submitted to the US Food and Drug Administration, and pending review, Aeras hopes to start Phase I clinical trial later this year to evaluate the safety and immunogenicity of ID93/GLA-SE in a group of healthy volunteers.
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-Gurin (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.
"Aeras is pleased to collaborate in the clinical development of this promising tuberculosis vaccine candidate," said Jim Connolly, President and CEO of Aeras.
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.
Source: North America News.Net
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