First Phase I study of vaccine candidate planned for this year
ROCKVILLE, Md. and SEATTLE, May 9, 2012 /PRNewswire-USNewswire/ -- 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-Guerin (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.
Tuberculosis is the world's second deadliest infectious disease, with 8.8 million new cases in 2010. Current guidelines require a minimum of six to nine months of treatment. TB is changing and evolving, making new vaccines more crucial for controlling the pandemic. Tuberculosis is the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.
About ID93 + GLA-SE
ID93 + GLA-SE is an investigational vaccine for the prevention of tuberculosis (TB). The vaccine consists of ID93, which is a recombinant fusion polyprotein comprised of Mycobacterium tuberculosis antigens associated with virulence or latency (Rv2608, Rv3619, Rv3620, and Rv1813) and Glucopyranosyl Lipid A – Stable Emulsion (GLA SE) as an immunological adjuvant. GLA is a Toll-like receptor 4 (TLR4) agonist that is formulated in an oil-in-water emulsion (SE) and is a synthetic analog of the well-studied adjuvant Monophosphoryl Lipid A (MPL®; GSK Biologicals).
Aeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. 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. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations, and governments. Aeras is based in Rockville, Maryland, USA where it operates a state-of-the-art manufacturing and laboratory facility, and Cape Town, South Africa.
The Infectious Disease Research Institute (IDRI) is a Seattle-based not-for-profit organization committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty. By integrating capabilities, including early stage drug discovery, preclinical testing, manufacturing, and clinical trials, IDRI strives to create an efficient pathway bringing scientific innovation from the laboratory to the people who need it most. For more information about IDRI's Tuberculosis program, please visit www.idri.org.
The preclinical studies of ID93/GLA-SE were funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under contract HHSN272200800045C and grant 5U01AI078054.
SOURCE Infectious Disease Research Institute (IDRI)