Subject: FDA
Shingrix with QS-21 Stimulon® Receives Positive Recommendation from CDC's Advisory Committee on Immunization Practices as Preferred Vaccine for Prevention of Shingles
LEXINGTON, Mass., Oct. 25, 2017 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of three recommendations for the use of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) containing QS-21 Stimulon® for the prevention of shingles (herpes zoster):
- Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults age 50 year and older.
- Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complication for immunocompetent adults who previously received Zoster Vaccine Live (Zostavax).
- Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications.
"The Advisory Committee's vote to recommend Shingrix enhanced with QS-21 Stimulon on three different counts further confirms our belief in the vaccine's efficacy and its potential to extend immunization for up to 62 million adults in the United States," remarked Garo Armen, Ph.D., Chairman and CEO, Agenus. "Today's vote confirms the importance of ensuring that millions of at-risk adults are protected against shingles with Shingrix."
QS-21 Stimulon is an immune-potent adjuvant designed to boost the immune system by helping the body generate antibodies and T cells that guard against infection. The addition of QS-21 Stimulon enhances the immunogenicity of Shingrix by boosting immune response, which is critically important for older adults, the population most vulnerable to shingles and the painful and often debilitating consequences of the virus.
Shingrix was approved by the US Food and Drug Administration (FDA) on October 20, 2017 for use in adults aged 50 years and older. Data from studies of people vaccinated with Shingrix, who were previously vaccinated with Zostavax, have been presented previously to the ACIP and have been published in peer-reviewed journals, but have not yet been reviewed by the FDA.[i],[ii]
The most common side effects of Shingrix are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach, which are related to the immune system responding to the vaccine. Based on available data, the majority of reactions to the vaccine were transient and mild to moderate in intensity, lasting less than three days.
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.
The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR).
About Agenus
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.
Forward-Looking Statements
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 potential for Shingrix to extend immunization for up to 62 million adults in the United States. 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.
Contact:
Agenus Inc.
Jennifer Buell, PhD
781-674-4420
[email protected]
i https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2017-06/zoster-03-colindres.pdf
SOURCE Agenus Inc.
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