Agenus Commences Phase 2 Study of HerpV Vaccine for the Treatment of Genital
*HerpV is the most clinically advanced therapeutic vaccine candidate for
the treatment of genital herpes
*Contains Agenus' QS-21 Stimulon^® adjuvant currently being studied in 17
LEXINGTON, Mass., Oct. 23, 2012 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN),
a developer of therapeutic vaccines for cancer and infectious diseases, today
announced that it has initiated a Phase 2 randomized, double-blind,
multicenter study of HerpV, a recombinant "off-the-shelf" therapeutic vaccine
candidate for the treatment of genital herpes in Herpes Simplex Virus 2
(HSV-2) positive subjects. HerpV contains Agenus' QS-21 Stimulon^®* adjuvant,
which is currently being studied in 17 additional clinical programs.
The study designated as protocol C-400-02 will enroll 75 HSV-2 positive
subjects who have a history of frequent disease recurrences. The study will
test the efficacy of the HerpV vaccine as measured by effect on genital viral
shedding. In the study, 65 participants will receive the active treatment,
HerpV and QS-21, and a control group of 10 participants will receive placebo.
A booster injection will be given at six months after treatment to evaluate
the durability of treatment effect.
The HerpV Phase 2 study design has been defined by key opinion leaders in the
field. Experts in HSV-2 clinical research believe that a reduction in viral
shedding, the driving force behind the spread of genital herpes, is an
important surrogate for clinical benefit in potentially reducing recurrent
"Our earlier clinical experience demonstrated an unprecedented immune response
with both arms of the immune system (CD8+ and CD4+ T cells) being activated in
subjects vaccinated with HerpV and QS-21, but not in subjects receiving
placebo," said Garo H. Armen, Ph.D., chairman and CEO of Agenus Inc.
"Incorporating a broad spectrum of herpes antigens along with QS-21 has the
potential enable the immune system's ability to recognize and destroy HSV-2
QS-21 is a key component of many vaccines in clinical development. Over the
next 15 months additional data from multiple important clinical programs that
contain QS-21 are expected to be disclosed. QS-21 is incorporated in several
vaccines currently in clinical development, including four GlaxoSmithKline
(GSK) Phase 3 programs.
About Heat Shock Protein Platform (HSP) and Recombinant Series HerpV
HerpV is a recombinant therapeutic vaccine for the treatment of genital
herpes, which is caused by the herpes simplex virus-2 (HSV-2).The vaccine is
based on Agenus' HSP platform technology, and is administered with Agenus'
proprietary adjuvant QS-21 Stimulon^® adjuvant.HerpV consists of recombinant
human heat shock protein-70 complexed with 32 distinct 35-mer synthetic
peptides from the HSV-2 proteome. This broad spectrum of herpes antigens is
intended to allow for more accurate immune targeting and surveillance,
reducing the likelihood of immune escape. Further, the diversity of antigens
in HerpV is designed to increase the chance of providing efficacy for a wide
segment of the patient population.
In a four-arm, Phase 1 study, 35 HSV-2 seropositive patients received HerpV
(designated in the study as AG-707 plus QS-21), AG-707, QS-21 alone, or
placebo. Patients received three treatments at two-week intervals. The vaccine
was generally well tolerated, with injection site pain as the most common
reported adverse event. All patients who received HerpV and were evaluable for
immune response showed a statistically significant CD4+ T cell response (100%;
7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those
patients demonstrated a CD8+ T cell response (75%; 6/8). This study was
published in the scientific journal Vaccine.
According to the Centers for Disease Control, genital herpes affects more than
60 million Americans — or 1 in 6 people between ages 14 and 49 — with an
additional 1.5 million new cases each year^(1). This disease often results in
recurrent painful sores in the genital area^(2). The emotional consequences of
genital herpes are quite significant, as 82 percent of people in the study
reported depression, 75 percent experienced fear of rejection, 69 percent
cited feelings of isolation and 55 percent reported fear of discovery -- all
due to infection^(3). Current therapies involve taking a daily medication that
only partly suppresses the virus.
About Agenus' QS-21 Stimulon^® Adjuvant
Agenus' flagship adjuvant, QS-21 Stimulon adjuvant, is a saponin extracted
from the bark of the Quillaja saponaria tree, also known as the soap bark tree
or Soapbark, an evergreen tree native to warm temperate central Chile.Agenus'
QS-21 has become a key component in the development of investigational
preventive vaccine formulations across a wide variety of infectious diseases,
and appears to be essential for several investigational therapeutic vaccines
intended to treat cancer and degenerative disorders. QS-21 Stimulon adjuvant
has been widely studied in clinical development and tens of thousands of
patients have received vaccines containing the adjuvant.QS-21 Stimulon
adjuvant is being studied in clinical trials for approximately 17 vaccine
programs and include GSK's Phase 3 vaccine programs for RTS,S for malaria,
MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma
and HZ/su for shingles. In addition, Janssen's QS-21 Stimulon
adjuvant-containing vaccine candidate is in Phase 2 trials for the treatment
of Alzheimer's disease.
Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on immunotherapeutic
products based on strong platform technologies with multiple product
candidates advancing through the clinic, including several product candidates
that have advanced into late-stage clinical trials through corporate partners.
For more information, please visit www.agenusbio.com.
The Agenus logo is available at
For more details about the HerpV C-400-02 study, please visit
www.clinicaltrials.gov using the identifier NCT01687595. The HerpV C-400-02
study participating centers include the following:
University of Washington Virology Research Clinic
Seattle, WA 98104
Principal Investigator: Anna Wald, MD
Contact: Kirsten Hauge, 206-720-4340
Westover Heights Clinic
Portland, OR 97210
Principal Investigator: Terri Warren, ANP
Contact: Annie Turner, 503-226-6678
Center for Clinical Studies – Texas Medical Center
Houston, TX 77030
Principal Investigator: Stephen K. Tyring, MD
Contact: Marigdalia Ramirez-Fort, MD, 713-528-8818
Center for Clinical Studies – Webster
Houston, TX 77598
Principal Investigator: Patricia C. Lee, MD
Contact: Farhan Khan, MD, 281-333-2288
Center for Clinical Studies – Cypress
Houston, TX 77065
Principal Investigator: Vandana Madkan, MD
Contact: Deborah Yetman, 713-554-4688
This press release contains forward-looking statements, including statements
regarding clinical trial activities, the publication of data, and the
potential application of the Company's technologies and product candidates in
the prevention and treatment of diseases. 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 ability
to recruit patients, sources of funding, decisions of doctors, patients and
our collaborations partners, the potential for viral shedding to act as a
surrogate for clinical benefit, and the factors described under the Risk
Factors section of our Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission for the period ended June 30, 2012. 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
document, and Agenus undertakes no obligation to update or revise the
statements. All forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Agenus' business is subject to
substantial risks and uncertainties, including those identified above. When
evaluating Agenus' business and securities, investors should give careful
consideration to these risks and uncertainties.
*QS-21 Stimulon^® adjuvant is an asset of Antigenics, Inc., a wholly owned
subsidiary of Agenus Inc.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.
1. Genital Herpes ‐ CDC Fact Sheet;
2. Herpes Virus; http://www.herpesonline.org/articles/herpes_virus.html
3. Clinical Management of Herpes Viruses by Stephen L. Sacks 1995
CONTACT: Media and Investors:
Jonae R. Barnes
Investor Relations &
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