UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the Securities Exchange Act of 1934
July
1, 2014
Date
of Report (Date of earliest event reported)
AGENUS INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
000-29089
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06-1562417
|
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
3 Forbes Road
Lexington, MA
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02421
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(Address
of principal executive offices)
|
(Zip
Code)
|
781-674-4400
(Registrant’s
telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01 Other events
Agenus Inc. announced final results from a single-arm,
multi-institutional, open-label, Phase 2 study showing that patients
with newly diagnosed glioblastoma multiforme (GBM) who received Agenus’
Prophage autologous cancer vaccine added to the standard of care
treatment, lived nearly twice as long as expected. In this Phase 2
study, 50% of the patients lived for two years, an encouraging result
for a cancer that often kills patients within one year 1-7. Prophage
patients demonstrated a median overall survival of approximately 24
months and 33% of patients remain alive at 2 years and continue to be
followed for survival.
In addition to the long-term survival data, vaccine treated patients had
a median progression-free survival (PFS) of nearly 18 months,
approximately two to three-times longer than patients treated with
radiation and temozolomide alone1. Importantly, 22% of
patients were alive and without progression at 24 months and continue to
be followed for survival.
The full text of the press release issued in connection with the
announcement is being filed as Exhibit 99.1 to this current report on
Form 8-K.
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.
Item 9.01 Financial
Statements and Exhibits
(d) Exhibits
The following exhibit is filed herewith:
99.1 Press Release dated July 1, 2014
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
AGENUS INC.
|
|
|
Date: July 1, 2014
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By:
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/s/ Garo H. Armen
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|
|
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Garo H. Armen
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Chief Executive Officer
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EXHIBIT INDEX
Exhibit No.
|
|
Description of Exhibit
|
|
|
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99.1
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Press Release dated July 1, 2014
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Exhibit 99.1
Agenus
Brain Cancer Vaccine Shows Extended Survival in Phase 2 Final Data
Analysis
-
Median
Overall Survival Nearly Double than Expected with Standard of Care
Alone
LEXINGTON, Mass.--(BUSINESS WIRE)--July 1, 2014--Agenus Inc. (NASDAQ:
AGEN), announced final results from a single-arm, multi-institutional,
open-label, Phase 2 study showing that patients with newly diagnosed
glioblastoma multiforme (GBM) who received Agenus’ Prophage autologous
cancer vaccine added to the standard of care treatment, lived nearly
twice as long as expected. In this Phase 2 study, 50% of the patients
lived for two years, an encouraging result for a cancer that often kills
patients within one year 1-7. Prophage patients demonstrated
a median overall survival of approximately 24 months and 33% of patients
remain alive at 2 years and continue to be followed for survival.
“These data suggest that Prophage is generating an effective immune
response which is translating into an extension in survival far beyond
what is historically seen in patients with GBM. These data provide the
impetus for a definitive, randomized clinical trial,” said Andrew Parsa,
MD, PhD,Principal Investigator of the study and the Michael J. Marchese
Professor and Chair of the Department of Neurological Surgery at the
Feinberg School of Medicine at Northwestern University. “Glioblastoma
tumors are often resistant to standard therapies and the extended
progression-free survival and proportion of long-term survivors is very
encouraging.”
In addition to the long-term survival data, vaccine treated patients had
a median progression-free survival (PFS) of nearly 18 months,
approximately two to three-times longer than patients treated with
radiation and temozolomide alone1. Importantly, 22% of
patients were alive and without progression at 24 months and continue to
be followed for survival.
Interestingly, the response to Prophage seems to be more pronounced in
those patients with less expression of the checkpoint ligand PDL-1 on
the white blood cells, suggesting that combinations of Prophage with
checkpoint modulators like PD-1 antagonists might make Prophage even
more effective in a greater percentage of patients with GBM.
“We believe that Prophage may play an important role in changing the
treatment paradigm for patients with GBM,” said Garo Armen, PhD, CEO and
chairman of Agenus Inc. “We are exploring partnerships for Phase 3
studies of Prophage in GBM. Additionally, we are excited about the
potential combinations of Prophage with PD-1 antagonists and other
checkpoint modulators in GBM.”
Prophage is an autologous cancer vaccine, and each patient receives
vaccine prepared from their own surgically resected tumor. As a result,
the vaccine appears to help stimulate the patient’s immune system to
attack the tumor based on the spectrum of mutant proteins expressed by
their own tumor. Since most cancers result from an accumulation of
random mutations, which produce different mutant proteins in each
patient, this approach is intended to individually tailor each patient’s
vaccine to optimally target the immune attack to that patient’s actual
tumor.
Phase 2 Prophage Study in Newly Diagnosed GBM
The Phase 2
single-arm trial of Prophage in patients with newly diagnosed GBM
undergoing gross total resection includes 46 patients treated at eight
centers (UCSF, Columbia, UPENN, Miami, Valley Hospital, Northern
Westchester Hospital, Oklahoma, Johns Hopkins, and Northwestern) across
the US. Patients were treated with surgical resection, radiation and
temozolomide as the standard of care in addition to Prophage
vaccination. The cohort was comparable to patients with surgically
resectable newly diagnosed GBM on prognostic factors such as age,
Karnofsky Performance Score, and MGMT methylation status. Analyses of
data collected to date show more than 50% of the patients were alive at
two years and patients continued to be followed. These results indicate
considerable improvement when compared to expectations for patients
treated with the standard of care (gross total resection plus radiation
and temozolomide), which is 26% of patients alive at 24 months.1
Median overall survival (OS), the primary endpoint of the trial, is 23.8
months and remains durable in patients treated with Prophage. For the
standard of care alone, median OS survival rate is 14.6 months.1 PFS
data remains durable with previous reports with a median PFS of 17.8
months and nearly 22% of patients alive without progression at 24 months.
The Phase 2 recurrent and newly diagnosed trials are being sponsored by
Dr. Parsa and primarily have been 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 the company.
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 Current treatment options for
patients with recurrent GBM, include surgery, chemotherapy (i.e.,
CCNU, temozolomide), bevacizumab, and radiotherapy.
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 conventional 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 is an immuno-oncology company developing a
portfolio of checkpoint modulators (CPMs), heat shock protein vaccines
and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery
engine Retrocyte Display® is used to generate fully
human therapeutic antibody drug candidates. The Retrocyte Display
platform uses a high-throughput approach incorporating IgG format human
antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat
shock protein vaccines for cancer and infectious disease are in Phase 2
studies. The company’s QS-21 Stimulon® adjuvant
platform is extensively partnered with GlaxoSmithKline and Janssen and
includes several candidates in Phase 3 trials. 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 March 31, 2014. 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. NEngl 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.
CONTACT:
Media and Investor Contact:
Agenus Inc.
Jonae
R. Barnes, 617-818-2985
Vice President
Investor Relations and
Corporate Communications
jonae.barnes@agenusbio.com
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