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Agenus, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Jonae R. Barnes, VP, Investor Relations and Corporate Communications, commented on the timing for data from the HerpV program. She stated, "Next, as I mentioned earlier, our HerpV randomized double blind, multi-center Phase 2 trial individuals infected with HSV-2 is fully enrolled and preliminary data results are expected during the fourth quarter of 2013."
Source: Q2 2013 earnings conference call, 7/25/13.

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Jonae R. Barnes, VP, Investor Relations and Corporate Communications, commented on a number of upcoming milestones. She stated, "The five key milestones that we expect during the second half of this year and into 2014 are the following: One, the phase-III data read-out of GSK's MAGE-A3 program for melanoma. Two, the phase-II data read-out for HerpV for the treatment of genital herpes. Three, long-term efficacy data for GSK's RTSS program for the prevention of malaria. Four, an update to our Prophage Series program for GBM and finally, five, the phase-III data read-out GSK's MAGE-A3 program for non-small cell lung cancer. These milestones could be a great value to us and to our shareholders as well as our partners."
Source: Q2 2013 earnings conference call, 7/25/13.

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Dr. Garo H.Armen, PhD, Chairman and Chief Executive Officer, gave guidance for data from the phase-II trial of HerpV for genital herpes. He stated, "First, we have completed patients screening for our phase-II randomize double-blind multicenter study for HerpV, a recombinant therapeutic vaccine candidate for the treatment of genital herpes in patients who have herpes. The study will test the biological efficacy of HerpV vaccine as measured by affect on genital viral shedding. We anticipate data from this trial during the fourth quarter 2013."
Source: Q1 2013 earnings confernce call, 4/24/13.

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HerpV is the most clinically advanced therapeutic vaccine candidate for the treatment of genital herpes
Contains Agenus' (AGEN) QS-21 Stimulon® adjuvant currently being studied in 17 clinical programs

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 outbreaks.

"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 infected cells."

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 IFN³ 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.
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Source: press release, 10/23/12. http://www.agenusbio.com/docs/pr/2012/1023.pdf

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A Phase 2a Multicenter, Double-blinded, Randomized Trial to Evaluate The Effect of HerpV on Viral Shedding in Adults With Recurrent Genital Herpes
Estimated Enrollment: 75
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01687595?term=C-400-02&rank=1

Compound/DeviceSpecialtyIndicationCompound ClassTarget
HerpVInfectious DiseaseHerpesVaccine therapeuticHerpes simplex virus-2 (HSV-2)

Mechanism of action: 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 contains Agenus' proprietary QS-21 Stimulon. 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 increases the chance of providing efficacy for a wide segment of the patient population.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2013-10-01 - 2013-12-31

Results:

Agenus’ HerpV Therapeutic Vaccine for Genital Herpes Meets Primary Endpoint in Randomized Phase 2 Trial

SUBJECTS TREATED WITH THE INITIAL THREE INJECTIONS OF HERPV SHOWED A STATISTICALLY SIGNIFICANT REDUCTION IN VIRAL SHEDDING, THE PRIMARY ENDPOINT
FINAL RESULTS AFTER BOOSTER INJECTION ARE EXPECTED DURING THE FIRST HALF OF 2014
Lexington, MA – November 7, 2013

Agenus Inc. (Nasdaq: AGEN), a developer of therapeutic vaccines for cancer and infectious diseases, today announced statistically significant top-line results from its Phase 2 randomized, double-blind, multi-center study for HerpV, a recombinant “off-the-shelf” therapeutic vaccine candidate for the treatment of patients with herpes simplex virus-2 (HSV-2). HerpV contains a defined mixture of peptides representing HSV-2 antigens plus Agenus’ QS-21 Stimulon®* adjuvant.

This Phase 2 study tested the biological efficacy of HerpV measuring genital viral shedding 45 days before and after three injections of HerpV. The primary analysis, which looked at viral shedding after the initial three injections, shows that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). These results suggest a 15% reduction in viral shedding after the initial treatment period before the administration of the booster injection. The results also demonstrate a reduction in viral load of 34% (P=0.08). Placebo patients showed no reduction compared to baseline in either parameter. Notably, patients were not on any antiviral treatments during their swabbing period. The initial data support that vaccination with HerpV has a real, measurable biological effect lowering the active shedding of the virus.

The majority of subjects in the study have received a booster injection of HerpV that was given six months after the first vaccination followed by determination of genital viral shedding for an additional 45-day period. Post-booster viral shedding results, along with immune response data, are anticipated in the first half of 2014.

“These data are exciting as we are finally seeing that we can direct the immune system to fight this disease,” said the study’s lead Principal Investigator, Anna Wald, M.D., Professor of Allergy and Infectious Diseases, University of Washington. “These HerpV data confirm that immune therapy may be an effective intervention in genital herpes; as such this is an exciting new finding.”

“These data are exceedingly promising as this is one of the first HSV vaccine trials to demonstrate a reduction in viral shedding and trends in decreasing viral load,” said Richard Whitley, M.D., Professor of Pediatrics, University of Alabama at Birmingham. “I am pleased to see this progress given the significant need for new treatment options for managing HSV-2 disease and its transmission on a global level.”

The HerpV Phase 2 study design was defined by key opinion leaders in the field. Experts in HSV-2 clinical research believe that a reduction in viral shedding is an important surrogate for clinical benefit in the form of reduction in recurrent outbreaks.
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Source: press release, 11/07/13. http://www.antigenics.com/docs/press-releases/2013/herpv-vaccine-for-gen...