GSK signs TB vaccine agreement
pharmafile | October 11, 2012 | News story | Research and Development, Sales and Marketing | Aeras, GSK, TB
GlaxoSmithKline Vaccines has signed a deal with US not-for-profit biotech Aeras to develop a new vaccine which will treat tuberculosis (TB).
At the same time, the manufacturer has made available a TB ‘compound library’ to help stimulate wider research into the disease and doubled investment in its Tres Cantos research facility with £5m more funding.
The Aeras candidate, known as M72/AS01E*, contains GSK’s proprietary M72 antigen and AS01E* adjuvant and had an ‘acceptable’ safety and reactogenicity profile and demonstrated an immune response in early stage clinical trials, the companies say.
They will now fund a Phase IIb proof of concept programme with healthy adults between 18 and 50 years of age, scheduled to begin in Kenya, India and South Africa next year.
Putting two million compounds that may help combat TB into the public domain mirrors GSK’s 2009 move to make public all its proprietary compounds relating to malaria.
Meanwhile the extra money for GSK’s ‘Open Lab’ at Tres Cantos in Spain will help the independent scientists who have been using GSK’s resources and facilities for research into a variety of diseases since the lab was set up in 2010.
As part of this move towards “greater openness, transparency and collaboration”, GSK is also making available data from clinical trials to other researchers.
The manufacturer has a specific R&D group focused on diseases of the developing world, including TB, and the Aeras candidate is being designed to be used with the currently available TB vaccine, Bacille Calmette-Guèrin (BCG).
The disease kills 1.4 million people, including children, each year – in part because TB is becoming increasingly drug resistant, but also because BCG does not prevent pulmonary TB, which accounts for the majority of infections and deaths among adolescents and adults.
TB is also the main cause of death for people living with HIV/AIDS, particularly in Africa.
There has been little movement in this therapy area for decades: in July Janssen submitted its investigational TB pill bedaquiline for review by the FDA as part of a combination therapy for pulmonary, multi-drug resistant TB.
If approved, it would be the first drug with a new mechanism of action for TB in more than 40 years.
M72/AS01E* could have a similar potential impact, believes Aeras chief executive Jim Connolly. But he warned: “Global financing for R&D remains critically low in this area.”
Earlier this year, philanthropist Bill Gates called on world leaders to back research into TB following the Global Fund to Fight AIDS, Tuberculosis and Malaria’s cancellation of its latest funding round.
Maryland-based Aeras, which receives money from the Bill & Melinda Gates Foundation and other donors, is supporting the clinical testing of six possible vaccines and has what it describes as a ‘robust’ portfolio of preclinical candidates.
Adam Hill
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