- Results Show Improved Survival Against
Aggressive Brain Cancer; More Than 90% of Patients Alive After Six
Months
Agenus Inc. (NASDAQ: AGEN), a biotechnology company developing
novel immune system activating treatments for cancers and
infectious diseases, today announced results published from a Phase
2 study demonstrated that more than 90% of the patients treated
with Prophage Series G-200 were alive at six months after surgery
and 30% were alive at twelve months. Additionally, the median
overall survival was approximately eleven months. This compares
favorably to the expected median survival for recurrent
Glioblastoma multiforme (GBM) patients of three to nine months1-7.
The primary objective of this multi-center, single arm Phase 2
trial was to assess the survival rate at six months.
The data was published in a manuscript in Neuro-Oncology, the
official journal of the Society of Neuro-Oncology. GBM is the most
common and most aggressive form of primary brain cancer. Despite
approved therapy patients with GBM face a poor prognosis. Prophage
Series vaccines are currently being studied in both newly diagnosed
and recurrent GBM.
“Glioblastoma tumors are often resistant to standard therapies
and the extended survival observed in patients treated with
Prophage Series vaccine is very promising,” said Andrew Parsa, MD,
PhD, corresponding author of the study and chair of neurological
surgery at Northwestern Memorial Hospital and the Michael J.
Marchese Professor and chair of the department of neurological
surgery at the Feinberg School of Medicine at Northwestern
University. “The next phase of development is underway with an NCI
funded, large-scale, randomized trial investigating Prophage Series
G-200 in combination with Avastin (bevacizumab). Avastin is
approved for the treatment of recurrent GBM and we believe there is
the potential for a synergistic effect of a targeted anti-tumor
immunotherapy and anti-angiogenic agent that could benefit
patients.”
Prophage Series vaccines are individualized cancer vaccines.
Each Prophage Series vaccine is manufactured using a patient’s own
tumor after surgical removal. Each vaccine contains the ‘antigenic
fingerprint’ of the patient’s particular cancer and is designed to
activate the patient’s immune system to specifically target and
destroy cancer cells bearing this fingerprint.
Prophage Series G-200 Study Design
The Phase 2 trial enrolled 41 patients with a mean age of 55
years with surgically resectable recurrent high-grade GBM, the
deadliest form of brain cancer. Patients underwent surgery to
remove ≥90% of their tumors (also referred to as gross total
resection), which were then used to manufacture Prophage Series
G-200, a patient-specific heat shock protein based therapeutic
vaccine. Eligible patients were treated after surgery with Prophage
Series G-200 once weekly for four weeks, followed by biweekly
injections until vaccine depletion. There were no serious adverse
events associated with vaccine administration. For further
information about this manuscript, please visit
http://neuro-oncology.oxfordjournals.org.
The trial was 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 travel expense reimbursement for this work or for
consulting activities on behalf of Agenus. Dr. Parsa does not have
an equity interest in Agenus or a financial relationship with the
company.
About the Randomized Prophage Series G-200
ALLIANCE Trial with Avastin in Recurrent GBM
The National Cancer Institute (NCI) is supporting a study of the
Prophage Series G-200 vaccine in a large-scale, multi-center,
randomized Phase 2 trial in combination with bevacizumab (Avastin®)
in patients with surgically resectable recurrent GBM. 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
study aims to advance the treatment of GBM, the most common and
malignant form of brain cancer.
The ALLIANCE trial is investigating the potential benefits of
treatment with a combination of Prophage Series G-200 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 Prophage
Series G-200 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 of Prophage Series G-200 and bevacizumab. For additional
information about the ALLIANCE trial visit ClinicalTrials.gov using
Identifier NCT01814813.
About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central
nervous system cancers have increased over the last three decades.8
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.9 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.10 The
current standard of care for patients with newly diagnosed GBM is
surgical resection followed by fractionated external beam
radiotherapy and systemic temozolomide11 resulting in a median OS
of 14.6 months12 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.13 From
the time of recurrence, the median survival is three to nine
months.1-7 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 Prophage Series Vaccines
Prophage Series vaccines are individualized cancer vaccines
derived from each patient’s own tumor. As a result of its
individualized nature, each Prophage Series vaccine contains the
precise signals (antigenic fingerprint) of the patient’s particular
cancer and allows the body’s immune system to target only cells
bearing this specific fingerprint. Such high precision in
immunological targeting represents a distinctly different method
for treating cancer compared to conventional anti-cancer treatments
such as chemotherapy or radiation therapy. These therapies cause
side effects which are sometimes debilitating.
Prophage Series vaccines are based on Agenus’ heat shock protein
platform technology. For more information about Prophage Series
vaccines and Agenus’ heat shock protein platform, please visit
http://agenusbio.com/science/prophage.php.
About Agenus
Agenus Inc. is a biotechnology company developing treatments for
cancers and infectious diseases. The company has multiple
immunotherapeutic products based on strong technology platforms
that are advancing through the clinic. Agenus’ technology is
further validated through partnerships with major pharmaceutical
companies, with several product candidates in late-stage clinical
trials with 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+. For more information, please visit
www.agenusbio.com.
Forward-Looking Statement
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 September 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.
References
1. Ballman KV, Buckner JC, Brown PD, et al. The relationship
between six-month progression-free survival and 12-month overall
survival end points for phase II trials in patients with
glioblastoma multiforme. Neuro Oncol. 2007;9:29–38.
2. Lamborn KR, Yung WK, Chang SM, et al. Progression-free
survival: an important end point in evaluating therapy for
recurrent high-grade gliomas. Neuro Oncol. 2008;10:162–170.
3. Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic
factors in recurrent glioma patients enrolled onto phase II
clinical trials. J ClinOncol. 1999;17:2572–2578.
4. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and
in combination with irinotecan in recurrent glioblastoma. J Clin
Oncol. 2009;27:4733–4740.
5. Kreisl TN, Kim L, Moore K, et al. Phase II trial of
single-agent bevacizumab followed by bevacizumab plus irinotecan at
tumor progression in recurrent glioblastoma. J Clin Oncol.
2009;27:740–745.
6. Vredenburgh JJ, Desjardins A, Herndon JE 2nd, et al.
Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J
Clin Oncol. 2007;25:4722–4729.
7. Sathornsumetee S, Desjardins A, Vredenburgh JJ, et al. Phase
II trial of bevacizumab and erlotinib in patients with recurrent
malignant glioma. Neuro Oncol. 2010;12:1300–1310.
8. 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.
9.
http://www.cancer.gov/cancertopics/pdq/treatment/adultbrain/HealthProfessional/page1
10. 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
11. National Comprehensive Cancer Network clinical practice
guidelines in oncology-central nervous system cancers.
v.1.2010.
12. Stupp, R., et al., Radiotherapy plus concomitant and
adjuvant temozolomide for glioblastoma. N Engl J Med, 2005.
352(10): p. 987-96.
13. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas:
emerging consensus on its benefits. Neurology.
2007;68(21):1762–1763. doi: 10.1212/01.wnl.0000266866.13748.a9.
Avastin is a registered trademark of
Genentech.
Media and Investor Contact:Jonae R. Barnes,
617-818-2985Vice PresidentInvestor Relations andCorporate
Communicationsjonae.barnes@agenusbio.com
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