Agenus (AGEN) announced that the U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously, recommending the approval of GlaxoSmithKline’s (GSK) shingles vaccine candidate, Shingrix, containing Agenus’ proprietary immune adjuvant, QS-21 Stimulon®.
This is good news for Agenus. As Garo Armen, Ph.D., Agenus CEO and Chairman of the Board said, “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. 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 Phase 1 clinical trial.
This is good news for Agenus, which has struggled for years to introduce preventive and therapeutic vaccines into the clinic. There is no doubt that Agenus proprietary immune adjuvant, QS-21 Stimulon is considered one of the best vaccine adjuvants that GSK is using for several preventive vaccines and Agenus is using it as a critical component of its neoantigen vaccine formulations.
Following the discovery of checkpoint proteins and the development of checkpoint inhibitors as immunotherapy for cancer with products being approved and demonstrating successes, Agenus moved into this new area of immunotherapy. Now the firm has several checkpoint targets and antibodies that inhibit them with some reaching clinical trials.
The company’s involvement in developing checkpoint inhibitors attracted Incyte (INCY).
We wrote about this firm before and we will post updates soon on its recent activities.
Be sure to read the Important news posted earlier under Today’s Highlights.
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