GSK seeks EU approval for malaria vaccine

RTS,S contains the QS-21 Stimulon adjuvant from Agenus

GlaxoSmithKline is applying for regulatory approval for the world's first vaccine against malaria, which has been trialled in children in Africa. The vaccine candidate, called RTS,S, has been accepted for regulatory review by the European Medicines Agency.

RTS,S contains Agenus’ QS-21 Stimulon adjuvant, which is part of GSK’s AS01 proprietary adjuvant system. Adjuvants can enhance the immune response when used in combination with antigens in vaccines.

'RTS,S has the potential to protect hundreds of thousands of children against malaria in Sub-Saharan Africa each year and we are proud to be part of this important programme,' said Robert Stein, Chief Scientific Officer of Agenus, a biotechnology company based in Lexington, MA in the US.

'RTS,S represents real progress in the decades of work to develop a malaria vaccine and we are gratified that our adjuvant was a key component.'

Malaria claims over 600,000 lives a year, most of which are children in Sub-Saharan Africa. Around 90% of estimated deaths from malaria occur in this region and 77% of these are in children under the age of five. RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in Sub-Saharan Africa. To date, there is no vaccine available for the prevention of malaria.

RTS,S represents real progress in the decades of work to develop a malaria vaccine

Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK, said: 'This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.'

Agenus has received a milestone payment for the regulatory submission of RTS,S, and is entitled to receive an additional milestone payment upon approval as well as royalties on product sales. No financial details have been released.

QS-21 Stimulon is also being evaluated in 16 additional vaccine candidates currently undergoing clinical study.

The Phase III RTS,S vaccine programme was conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) and included over 16,000 children. These data have been included to support the regulatory filing.

If the EMA grants approval to the vaccine, the World Health Organization said a policy recommendation may be possible by the end of 2015.

Approval from the EMA would also be the basis for marketing authorisation applications to National Regulatory Authorities (NRAs) in Sub-Saharan Africa countries.

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