Agenus Announces Oral Presentation at ASCO Highlighting Improved Survival with Prophage Immunotherapy in Brain Cancer Compare...
May 14 2015 - 7:00AM
Business Wire
Improved median Overall Survival and
Progression Free Survival observed for Prophage-treated patients
with Lower PD-L1 expression on peripheral blood monocytes at
baseline
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 AgenusAgenus 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, or connect with the
company on Facebook, LinkedIn, Twitter and Google+; information
that may be important to investors will be routinely posted in
these locations.
Forward-Looking StatementThis 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.
Media:BMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestors:Argot
PartnersAndrea Rabney, 212-600-1902andrea@argotpartners.comorJamie
Maarten, 212-600-1902jamie@argotpartners.com
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