Agenus Reports Positive Follow-on Phase 2 Results for Brain Cancer Vaccine
in Newly Diagnosed Patients
Analysis of patients treated with Prophage Series G-100 (HSPPC-96) show
improvement in progression free survival and overall survival versus standard
Results support advancement to Phase 3 trial for HSPPC-96
LEXINGTON, Mass. -- September 17, 2013
Agenus Inc. (NASDAQ: AGEN) today announced that a recent analysis from a Phase
2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) treated
with Prophage Series G-100 (HSPPC-96) in combination with the current standard
of care (radiation and temozolomide) showed an almost 18 month median
progression free survival (PFS), which represents a 160% increase versus
current standard of care alone. This analysis confirms continuation of the
positive trends from the Phase 2 HSPPC-96 newly diagnosed GBM trial first
reported at the 81^st American Association of Neurological Surgeons (AANS)
Annual Scientific Meeting in May 2013.
“These additional results from the Phase 2 trial of HSPPC-96 in patients with
newly diagnosed GBM are extremely encouraging and certainly justify a
definitive randomized study,” said Andrew T. Parsa, MD, PhD, Lead Clinical
Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital and
Northwestern University Feinberg School of Medicine. “The patient-specificity
and lack of toxicity, combined with patient selection to optimize
immunotherapy efficacy, could position this vaccine as a break-through
treatment for newly diagnosed GBM patients in the years ahead.”
Based on these findings, Agenus plans to hold an end of Phase 2 meeting with
the US Food and Drug Administration to discuss a Phase 3 trial that could
potentially lead to marketing approval of the HSPPC-96 vaccine as a treatment
for patients with newly diagnosed GBM.
Phase 2 HSPPC-96 Update in Newly Diagnosed GBM Patients
The Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM includes 46
patients treated at eight centers across the US. Patients were treated with
radiation and temozolomide as the standard of care in addition to HSPPC-96
vaccination. Analyses of data collected to date show a median PFS of 17.8
months with 63% of the patients progression free at twelve months and 20%
progression free at 24 months. These results indicate considerable improvement
when compared to patients treated with the standard of care (radiation plus
temozolomide), which is 6.9 months.^1
Median overall survival (OS), the primary endpoint of the trial, is 23.3
months and remains durable in patients treated with HSPPC-96. In this study,
the 12 month survival rate is 85% with 50% of patients still alive and being
followed, with many surviving beyond the 24 month study period. For the
standard of care alone, median OS survival rate is 14.6 months.^1
The Phase 2 recurrent and newly diagnosed trials are being sponsored by Dr.
Parsa and are primarily supported through funding from the American Brain
Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor
Society, and National Cancer Institute Special Programs of Research
Excellence. Dr. Parsa has not received any financial support or expense
reimbursement for this work or for consulting activities on behalf of Agenus.
He does not have an equity interest in Agenus or a financial relationship with
About the Randomized HSPPC-96 ALLIANCE Trial in Recurrent GBM
In addition to the Phase 2 newly diagnosed GBM trial, the Cancer Therapy
Evaluation Program (CTEP) of the National Cancer Institute (NCI) is supporting
a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in
combination with bevacizumab (Avastin^®) in patients with surgically
resectable recurrent GBM. Patients have already been randomized into this
trial and active recruitment is underway at multiple centers in the US. The
study is being sponsored by the Alliance for Clinical Trials in Oncology
(ALLIANCE), a cooperative group of the NCI. This trial is the largest brain
tumor trial ever funded by the NCI and the largest vaccine study ever
conducted with Avastin.
The ALLIANCE trial is investigating the potential benefits of treatment with a
combination of HSPPC-96 and bevacizumab in a three-arm study of approximately
222 patients with surgically resectable recurrent GBM using a primary endpoint
of overall survival. The study will compare efficacy of the HSPPC-96 vaccine
administered with bevacizumab either concomitantly or at progression, versus
treatment with bevacizumab alone. This study design is supported in part by
previous research indicating a potential synergistic effect between the
mechanisms of action behind both HSPPC-96 and bevacizumab. For additional
information about the ALLIANCE trial visit ClinicalTrials.gov using Identifier
The ALLIANCE is composed of three NCI funded cooperative groups (American
College of Surgeons Oncology Group [ACOSOG], Cancer and Leukemia Group B
[CALGB], and North Central Cancer Treatment Group [NCCTG]). These three groups
have been integrated in an effort to develop and conduct more efficient
clinical research studies to bring clinical trial results to patients more
In addition to the newly diagnosed GBM study in Prophage Series G-100 and the
ALLIANCE trial, a Phase 2 study testing the Prophage Series G-200 in patients
with recurrent glioma has been completed. Agenus expects the final trial
results of this study to be published in a scientific journal in 2014.
About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central nervous system
cancers have increased over the last three decades.^2 The American Cancer
Society estimates that more than 23,000 malignant tumors of the brain or
spinal cord will be diagnosed during 2013 in the US, and that more than 14,000
people will die from these tumors. ^ 3 GBM is the most common primary
malignant brain tumor and accounts for the majority of diagnoses. It has been
associated with a particularly poor prognosis, with survival rates at one and
five years equaling 33.7% and 4.5%, respectively.^4 The current standard of
care for patients with newly diagnosed GBM is surgical resection followed by
fractionated external beam radiotherapy and systemic temozolomide^5 resulting
in a median OS of 14.6 months^6 based on data from a randomized Phase 3 trial.
Although this treatment can prolong survival, it is not curative and the vast
majority of patients with GBM experience recurrent disease, with a median time
to recurrence of seven months.^7 Currently, there is no standard treatment for
patients with recurrent GBM, although additional surgery, chemotherapy (i.e.,
CCNU, temozolomide), bevacizumab, and radiotherapy are used.
About the Prophage Series (HSPPC-96) Cancer Vaccines
Prophage Series cancer vaccines are autologous therapies derived from cells
extracted from the patient’s tumor. As a result, Prophage Series vaccines
contain a precise antigenic ‘fingerprint’ of a patient’s particular cancer and
are designed to reprogram the body’s immune system to target only cells
bearing this fingerprint, reducing the risk that powerful anti-cancer agents
will target healthy tissue and cause debilitating side effects often
associated with chemotherapy and radiation therapy. The Prophage Series G
vaccines are currently being studied in two different settings of
glioblastoma: newly diagnosed and recurrent 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.
Between Agenus and its partners, 23 programs are in clinical development. For
more information, please visit www.agenusbio.com, or connect with the company
on Facebook, LinkedIn, Twitter and Google+.
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 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, 2013. 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.
1. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N
Engl J Med, 2005. 352(10): p. 987-96.
2. Maher EA, McKee AC. In: Atlas of diagnostic oncology. 3. Skarin AT,
Canellos GP, editor. London: Elsevier Science; 2003. Neoplasms of the central
nervous system; pp. 5–10.
4. Central Brain Tumor Registry of the United States (CBTRUS) 2010 CBTRUS
statistical report: primary brain and central nervous system tumors diagnosed
in the United States in 2004-2006. http://www.cbtrus.org/reports/reports.html
5. National Comprehensive Cancer Network clinical practice guidelines in
oncology-central nervous system cancers. v.1.2010.
6. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N
Engl J Med, 2005. 352(10): p. 987-96.
7. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging
consensus on its benefits. Neurology. 2007;68(21):1762–1763. doi:
Avastin is a registered trademark of Genentech.
Media and Investor Contact:
Jonae R. Barnes, 617-818-2985
Investor Relations and Corporate Communications
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