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Corporate News Blog - GSK's Shingles Vaccine with Agenus' QS-21 Stimulon(R) Adjuvant Gets FDA Approval in US

LONDON, UK / ACCESSWIRE / October 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for GlaxoSmithKline PLC (NYSE: GSK) ("GSK"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=GSK. The Company announced on October 20, 2017, that the US Food and Drug Administration (FDA) has granted marketing authorization to its herpes zoster vaccine, SHINGRIX, containing the proprietary immune adjuvant QS-21 Stimulon® of Agenus Inc. (NASDAQ: AGEN). For immediate access to our complimentary reports, including today's coverage, register for free now at:

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SHINGRIX is indicated for the prevention of herpes zoster, also known as shingles, in adults aged 50 years and older. The addition of QS-21 Stimulon® helps improve the vaccine's effectiveness by boosting the immune response in older adults who often experience age-related decline in immunity.

Why the Drug Matters

Shingles is a major public health issue in the US, impacting as many as 1 in 3 older adults over the age of 50 years. Shingles is caused by a virus called varicella zoster, which is also known as the chicken pox virus. Nearly all older adults have the varicella zoster virus dormant in their nervous system waiting to reactivate with advancing age and weakened immune systems.

QS-21 Stimulon® is an immune-potent adjuvant designed to boost the immune system by helping the body generate antibodies and T cells which guard against infections. The addition of QS-21 Stimulon® to the SHINGRIX vaccine enhances the immune response in these older adults.

Results

The FDA approval of SHINGRIX was based on data pooled from two pivotal Phase-III clinical trials in more than 38,000 people. SHINGRIX demonstrated an efficacy rate against shingles greater than 90% independent of age, as well as a sustained efficacy over the four-year follow-up period. SHINGRIX also reduced the overall incidence of post-herpetic neuralgia (PHN), the most common and oftentimes debilitating chronic nerve pain associated with shingles. The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of shingles.

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' neo-antigen 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.

Going Forward

On 13 October, 2017, SHINGRIX was approved in Canada for the prevention of shingles in people aged 50 years, or older. GSK noted that the regulatory filings in the European Union, Australia, and Japan are underway. Following this approval from the FDA, and pending a recommendation from ACIP, SHINGRIX will be available in the US shortly.

About Agenus Inc.

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.

About GlaxoSmithKline PLC

GSK is one of the world's leading research-based pharmaceutical and healthcare Companies, committed to improving the quality of human life by enabling people to do more, feel better, and live longer.

Last Close Stock Review

On Monday, October 23, 2017, the stock closed the trading session at $40.62, slightly down 0.54% from its previous closing price of $40.84. A total volume of 6.87 million shares have exchanged hands, which was higher than the 3-month average volume of 3.32 million shares. GlaxoSmithKline's stock price advanced 0.10% in the last one month. Furthermore, since the start of the year, shares of the Company have gained 5.48%. The stock is trading at a PE ratio of 39.13 and has a dividend yield of 4.90%. The stock currently has a market cap of $99.21 billion.

Agenus' share price finished yesterday's trading session at $4.26, sliding 1.62%. A total volume of 12.06 million shares have exchanged hands, which was higher than the 3-month average volume of 1.10 million shares. The Company's stock price rallied 3.90% in the last one month and 15.14% in the past six months. Additionally, the stock gained 3.40% since the start of the year. The stock currently has a market cap of $382.63 million.

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SOURCE: Pro-Trader Daily