- Agenus' HerpV Named One of the "2012 Top Programs to Watch" by Windhover
LEXINGTON, Mass., Nov. 26, 2012 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a developer of therapeutic vaccines for cancer and infectious diseases, today announced that Cristina Musselli, MD, Ph.D, Senior Director of Preclinical Development and Translational Medicine at Agenus, will be presenting at Windhover's Therapeutic Area Partnerships Conference on Thursday, November 29, 2012. The conference will be held at the Westin Copley Place in Boston, MA.
Dr. Musselli will present an overview of HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate in Phase 2 clinical development 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 clinical programs.
About Recombinant Series HerpV
The HerpV Phase 2 study (designated as protocol C-400-02) plans to enroll 75 HSV-2 positive subjects who have a history of frequent disease recurrences. The study, which was initiated in late October 2012, has already screened over 25% of the needed subjects. The primary aim of the trial is to test the efficacy of the HerpV vaccine as measured by effect on genital viral shedding after three injections. A booster injection of HerpV will also be given at six months after the initial treatment to evaluate the durability of efficacy. 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 outbreaks.
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' Heat Shock Protein 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.
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.
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About The Windhover Conference
Windhover's Therapeutic Area Partnerships conference is a uniquely focused meeting among R&D, financing and business development leadership to improve the partnering process and encourage innovative thinking about productivity and deal making. For more information on the conference and presenting companies please go to http://www.tapartnerships.com.
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 September 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 and the related agreements, and HerpV are assets of Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
Stimulon is a registered trademark of Agenus Inc. and its subsidiaries.
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