Agenus Inc (AGEN)

[H2R]

Shingrix (with AGEN Adjuvant): Health Canada Marketing Authorization

Fri October 13, 2017 2:09 PM|PR Newswire|About: AGEN
PR Newswire
LEXINGTON, Mass., Oct. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that Health Canada granted marketing authorization to GlaxoSmithKline's (GSK) shingles vaccine, Shingrix, that contains Agenus' proprietary immune adjuvant QS-21 Stimulon® adjuvant. The approval in Canada marks the first approval for Shingrix and the first approval of a vaccine containing QS-21 Stimulon.


In September of this year, Shingrix, was unanimously recommended for approval by the FDA Vaccines and Related Biological Products Advisory Committee. A decision by FDA on whether to approve Shingrix in the United States is anticipated in the coming weeks.

QS-21 Stimulon is an immune-potent adjuvant designed to help the body generate antibodies and T cells, which guard against infection with viruses, parasites and bacteria. The approval of Shingrix in Canada is based on efficacy data collected in more than 37,000 people which demonstrated an efficacy rate against shingles greater than 90%,and this is independent from age (≥50 and ≥70 years of age), as well as a sustained efficacy over the entire follow-up period. Most common side effects reported in clinical trials were pain, redness and swelling at the injection site and the majority of which were transient and mild to moderate in intensity, lasting less than three days.

"The approval of the Shingrix vaccine containing Agenus' QS-21 Stimulon is a major and most exciting development for the eligible population for GSK, and for Agenus (AGEN). This approval confirms our belief that the addition of our proprietary immune adjuvant improves vaccine effectiveness and, ultimately, brings benefit to patients," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "The Canadian approval marks the first of further decisions on approvals for Shingrix. We look forward to the FDA decision in the near future."

The addition of QS-21 Stimulon is being studied to determine its potential to help a diverse range of vaccines work more effectively to treat or cure difficult-to-treat diseases, like cancer. QS-21 Stimulon is currently being used in combination with Agenus' neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial in cancer.

QS-21 Stimulon is also currently being evaluated in numerous GSK vaccine development candidates for both therapeutic and prophylactic applications.

https://seekingalpha.com/pr/16968267-gsks-shingrix-containing-agenus-qsminus-21-stimulon-adjuvant-receives-marketing-authorization