Agenus announced that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon, was unanimously recommended for approval by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee.
"The Advisory Committee's recommendation for the approval of Shingrix marks the first for a product that includes Agenus' proprietary immune adjuvant, QS-21 Stimulon, and serves as a significant validation," said Garo Armen, Ph.D., Agenus CEO and Chairman of the Board. "In addition to being studied in diverse development stage vaccines, QS-21 Stimulon is also a critical component of our neoantigen vaccine formulations. We believe QS-21 provides Agenus with a competitive advantage due to its demonstrated ability to bolster immunogenicity in diverse vaccine formulations offering potential benefit to patients."
A Biologics License Applications (BLA) filed with the FDA by GSK for Shingrix for the prevention of herpes zoster (also known as shingles) in people aged 50 years and older is under regulatory review. The FDA will consider the Advisory Committee vote as it reviews the BLA, although it is not required to follow the recommendation.
GSK's shingles vaccine candidate is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway
QS-21 Stimulon is being evaluated in various GSK development candidates in addition to being studied in Agenus' neoantigen vaccine, AutoSynVax, now in a Phase 1 clinical trial.