Agenus Inc. (Nasdaq: AGEN), a biotechnology company developing
novel immune system activating treatments for cancers and
infectious diseases, announced that Phase 2 results of Prophage
G-200 vaccine in recurrent patients with glioblastoma multiforme
(GBM) were hailed as ‘exciting’ and a ‘very promising therapy’ in
an editorial published in Neuro-Oncology, the leading journal of
the Society of Neuro-Oncology.
The results of Agenus’ Prophage vaccine Phase 2 study, published
last month in Neuro-Oncology, demonstrated that more than 90% of
the patients treated with the vaccine candidate were alive at six
months. The median overall survival in these patients was
approximately 11 months.
In an independent editorial, John Sampson, MD, PhD, The Dr.
Robert H. Wilkins and Gloria Wilkins Professor of Neurosurgery
and Professor of Immunology and Pathology at Duke University
Medical Center, called the results ‘impressive’ and said they
represent a potentially ‘very promising therapy’ in patients in
desperate need of new treatments.
The results of the Phase 2 trial have garnered the support of
the National Cancer Institute (NCI). The NCI is funding the largest
cancer vaccine trial investigating Prophage vaccine in combination
with Avastin® (bevacizumab) in patients with recurrent
glioblastoma. The study is actively enrolling and will offer the
opportunity to provide important data to validate assessments of
biomarkers and imaging criteria, which is needed to advance the
understanding of treatment for patients with GBM.
“We are excited about these results and the enthusiasm of our
colleagues,” 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. “We are also
enthusiastic about the ongoing NCI Alliance trial and the
opportunity to not only advance a new therapy for patients with GBM
but to support the development of innovative immunologic and
imaging tools.”
Prophage G-200 Vaccine 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 G-200
vaccine, a patient-specific heat shock protein based therapeutic
vaccine. Eligible patients were treated after surgery with Prophage
G-200 vaccine 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 G-200 Vaccine ALLIANCE Trial
with Avastin in Recurrent GBM
The National Cancer Institute (NCI) is supporting a study of the
Prophage 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 study represents the largest brain tumor vaccine 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 G-200 vaccine 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
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 G-200 vaccine 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 Vaccines
Prophage vaccines are individualized cancer vaccine candidates
derived from each patient’s own tumor. As a result of its
individualized nature, each Prophage 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 vaccines are based on Agenus’ heat shock protein
platform technology. For more information about Prophage 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.NAL
Avastin is a registered trademark of Genentech
Agenus Inc.Jonae R. Barnes, 617-818-2985Vice President Investor
Relations and Corporate
Communicationsjonae.barnes@agenusbio.com
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