Antigenics has indicated that GlaxoSmithKline’s (GSK) Phase III malaria vaccine clinical trial, containing Antigenics’ QS-21 Stimulon adjuvant, has enrolled more than 5,000 children to date and is expected to involve up to 16,000 children. The pivotal efficacy study of RTS,S, the clinically advanced malaria vaccine, is ongoing in seven African countries.
Antigenics’ QS-21 is currently being evaluated in approximately 20 vaccine indications, of which several are in late-stage clinical trials by Antigenics’ licensees, including GSK and Janssen Alzheimer Immunotherapy.
Under the terms of the license and supply agreements between the companies, Antigenics will receive payments from GSK contingent upon achievement of milestones and from royalties on net sales for a period of at least 10 years after the first commercial sale.
According to the company, under current plans, the RTS,S vaccine candidate will be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age. Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available.
Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years, the company said.
Garo Armen, chairman and CEO of Antigenics, said: “QS-21 has emerged as an important component in 15 vaccine products being tested in clinical trials. QS-21 could become a significant revenue source for Antigenics in the coming years.”