GSK' Malaria Vaccine Containing Agenus'QS-21 Stimulon Gets Positive CHMP Opinion

(RTTNews) - Agenus Inc. (AGEN) announced that GlaxoSmithKline (GSK, GSK.L) received a positive opinion for its Malaria vaccine candidate from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA.

The vaccine candidate, named Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision. Agenus' adjuvant QS-21 is designed to increase immune response to antigens in vaccines. The positive opinion signals that Mosquirix meets the necessary quality, safety and efficacy requirements according to EU standards.

Following the CHMP positive opinion, two of the World Health Organization's (WHO) independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), will now jointly review the evidence base for the vaccine candidate and make a joint policy recommendation for how the vaccine should be used in the event that it ultimately is approved by the national regulatory authorities in the sub-Saharan African countries for which the vaccine is intended.

The WHO has indicated that such a policy recommendation may be possible by end of this year.