Agenus Inc. (NASDAQ:AGEN), an immunology company developing innovative treatments for cancers and other diseases, today announced that data on continuing survival from a Phase 2 study of its Prophage vaccine in glioblastoma multiforme (GBM) has been selected for an oral presentation at the 2015 ASCO Annual Meeting, to be held May 29 – June 2, 2015 in Chicago. The presentation, abstract #2011 entitled “Newly diagnosed glioblastoma patients treated with an autologous heat shock protein peptide vaccine: PD-L1 expression and response to therapy,” will be presented during the Clinical Science Symposium at 8:48am CST by Orin Bloch, MD, Khatib Professor of Neurological Surgery and Assistant Professor of Neurological Surgery and Neurology at Northwestern University Feinberg School of Medicine.
Study Highlights
- Patients treated with Prophage added to Standard of Care (SOC) showed significantly longer progression free survival and overall survival compared to historical data for patients receiving SOC alone
- Patients in the study showed a degree of elevation of PD-L1 on their peripheral blood monocytes and in tumor infiltrating macrophages
- In patients who had less PD-L1 on monocytes at baseline, the median Overall Survival (mOS) was approximately 45 months, with a significant proportion of patients alive without progression for more than 3.5 years
- In patients who had more PD-L1 on monocytes at baseline, the mOS was 18 months, still better than expected from historical data
“These are impressive results in a disease that has few effective treatments or promising candidates in development,” commented Orin Bloch, M.D. “We’re particularly gratified to observe the very impressive survival data in the half of our patients with lower PD-L1 monocyte expression at baseline. Not only is the median Overall Survival much better than expected, but there is a significant proportion of patients who are living longer than expected without progression. We are also intrigued by the possibility that blocking the PD-1 / PD-L1 axis in conjunction with Prophage in patients with elevated PD-L1 may allow the outcomes observed in the lower PD-L1 group to extend to these patients as well.”
Study Details
The Phase 2 single-arm trial enrolled forty-six adult patients newly diagnosed with GBM from eight centers in the U.S. Each patient received standard treatment of surgical resection followed by chemoradiation. Within five weeks of completing radiotherapy, patients received weekly Prophage injections for four weeks followed by monthly Prophage injections, and adjuvant temozolomide until the depletion of vaccine or tumor progression. Expression of PD-L1 has been shown to be elevated in patients with GBM, and each patient was also evaluated for PD-L1 expression as a predictor of survival.
The primary endpoint of the trial was overall survival. Median progression-free survival in the trial was 17.8 months (95% CI, 11.3 – 21.6), and median overall survival was 23.8 months (95% CI, 19.8 – 30.2). This compares to a historical overall survival of 14.8 – 18.8 months for patients receiving standard of care alone. The vaccine was well-tolerated in the study with no severe adverse events attributed to the treatment.
The median overall survival for patients with high PD-L1 expression (above the median, 54% of monocytes) was 18.0 months (95% CI, 10.0 – 23.3). Median overall survival for patients with low PD-L1 expression was 44.7 months (95% CI not calculable).
“These data continue to impress, and we’re gratified they were selected by ASCO for an oral presentation,” commented Dr. Robert Stein, Chief Scientific Officer of Agenus. “Prophage monotherapy, in patients with low PD-L1 expression in peripheral blood monocytes at baseline, appears to show a substantial increase in survival compared to historical controls. Registrational study planning is underway for Prophage, and we will provide further updates later this year.”
About Agenus
Agenus is an immunology company developing a
series of Checkpoint Modulators for the treatment of patients with
cancer, infectious diseases, and other immune disorders, heat shock
protein (HSP)-based vaccines, and immune adjuvants. These programs are
supported by three synergistic technology platforms. Agenus’ internal
and partnered checkpoint modulator programs target GITR, OX40, CTLA-4,
LAG-3, TIM-3, PD-1 and other undisclosed immune-modulatory targets. The
company’s proprietary discovery engine Retrocyte DisplayTM is
used to generate fully human and humanized 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 recently acquired a powerful yeast
antibody display platform termed SECANT, developed by Celexion, LLC.
SECANT allows rapid generation of soluble, full-length human antibodies.
SECANT and Agenus’ mammalian antibody display platform have
complementary strengths and further bolster Agenus' abilities to
generate and optimize fully human monoclonal antibodies. Agenus’ heat
shock protein-based vaccines have completed Phase 2 studies in newly
diagnosed glioblastoma multiforme, and in the treatment of herpes
simplex viral infection; the heat shock protein-based vaccine platform
can generate personalized as well as off the shelf products. The
company’s QS-21 Stimulon® adjuvant platform is extensively partnered
with GlaxoSmithKline and with Janssen Sciences Ireland UC and includes
several candidates in Phase 2 trials, as well as shingles and malaria
vaccines which have successfully completed Phase 3 clinical trials. For
more information, please visit www.agenusbio.com,
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information that may be important to investors will be routinely posted
in these locations.
Forward-Looking Statement
This press release contains
forward-looking statements that are made pursuant to the safe harbor
provisions of the federal securities laws, including statements
regarding the upcoming presentation at ASCO, the potential application
of the Company’s product candidate in the remediation of GBM, and
potential future clinical trial plans. 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 most
recent Quarterly Report on Form 10-Q or annual report on Form 10-K filed
with the Securities and Exchange Commission. 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 press release, and Agenus undertakes no obligation to update or
revise the statements, other than to the extent required by law. All
forward-looking statements are expressly qualified in their entirety by
this cautionary statement.
Contacts:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com
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Investors:
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Partners
Andrea Rabney, 212-600-1902
andrea@argotpartners.com
or
Jamie
Maarten, 212-600-1902
jamie@argotpartners.com