FDA Panel Unanimously Backs GlaxoSmithKline's Blockbuster-Potential Shingles Vaccine
Published: Sep 14, 2017
LEXINGTON, Mass., Sept. 13, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today 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.
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing a number of combination approaches that leverage a broad repertoire of antibody therapeutics and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com; information that may be important to investors will be routinely posted on our website.
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the FDA's pending review of GSK's BLA for Shingrix, as well as statements regarding Agenus' product candidates and clinical trial plans and activities. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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SOURCE Agenus Inc.