Tuesday, October 18, 2011

Agenus agent shown effective in malaria vaccine trial

By Lori Valigra, Mass High Tech correspondent

A large Phase 3 trial in Africa run by GlaxoSmithKline (GSK) Biologicals and its partners showed that the company’s RTS,S malaria vaccine, which includes an agent from Agenus Inc. of Lexington, gave significant protection to very young African children.

This is the first time a vaccine containing Agenus’ QS-21 Stimulon adjuvant, an agent that helps boost the impact of a vaccine, was shown to be effective in a Phase 3 trial. QS-21 is being studied in 15 indications, including in four Phase 3 studies by GSK. QS-21 is part of GSK’s AS01B adjuvant in the malaria vaccine.

Results of the malaria vaccine trial are being reported in today’s New England Journal of Medicine and being announced at the Malaria Forum in Seattle, Wash. The study is the largest malaria vaccine efficacy and safety trial ever run in Africa by GSK and its partners, which include the World Health Organization and the Bill & Melinda Gates Foundation. The RTS,S vaccine candidate reduced the risk of clinical and severe malaria in youngsters by 56 percent and 47 percent, respectively, for the 12-month period following vaccination.

Malaria causes around 800,000 deaths each year, mostly children under age five in sub-Saharan Africa. The Phase 3 trial was conducted at 11 trial sites in seven countries across sub-Saharan Africa in 6,000 children aged 5 to 17 months. A second Phase 3 trial is currently underway in 9,000 infants aged 6-12 weeks, and results are expected in 2012, Agenus said.

“The adjuvant is a critical engine of a vaccine,” said Garo H. Armen, chairman and CEO of Agenus. “The results from this trial mark a significant milestone for our adjuvant business. It is the first time a QS-21-containing vaccine has shown efficacy in a Phase 3 trial.” Armen said that over the next 15 months the company expects additional pivotal data from multiple clinical programs being developed by its corporate partners, including non small cell lung cancer and melanoma vaccines in progress at GSK and an Alzheimer’s vaccine from Johnson & Johnson.

Agenus will receive milestone payments as QS-21-containing programs advance, as well as royalties for 10 years after commercial launch. Once those products are commercialized, Armen said, the company has the potential to get more than $100 million per year.