LEXINGTON, Mass., Jan. 17, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with a pipeline of
immune checkpoint antibodies and cancer vaccines, today announced a
clinical trial collaboration with the National Cancer Institute
(NCI). The double-blind, randomized controlled Phase 2 trial will
evaluate the effect of Agenus' personalized autologous vaccine
candidate, Prophage™ (HSPPC-96), in conjunction with Merck's
pembrolizumab on the overall survival rate of patients with newly
diagnosed glioblastoma (ndGBM). The trial will be conducted by the
Brain Tumor Trials Collaborative (BTTC), a consortium of top
academic centers led by Dr. Mark
Gilbert, Chief of the Neuro-Oncology Branch at the NCI
Center for Cancer Research.
The trial aims to assess the efficacy of PD-1 targeted
checkpoint blockade in combination with a heat-shock protein based
vaccine candidate in an indication in which this vaccine has shown
improved progression-free survival, as presented at ASCO 2015. It
is a two-arm trial with one arm receiving pembrolizumab as a
monotherapy and a second arm receiving both Prophage and
pembrolizumab in combination. Forty-five patients will be randomly
assigned to each arm.
Under this collaboration, Agenus will supply Prophage™, Merck
will provide pembrolizumab (Keytruda®) and NCI and BTTC
member sites will recruit patients and conduct the trial.
About Prophage™
Prophage is an individualized
autologous vaccine candidate derived from proteins extracted from
the patient's tumor. The vaccine candidate consists of heat shock
protein peptide complexes that include the chaperone gp-96
(HSPPC-96) naturally bound to tumor protein fragments.
Administration of HSPPC-96 bearing the precise antigenic
fingerprint of the patient's particular cancer represents an
effective immune education strategy that enhances recognition of a
tumor as 'non-self' leading to a potent anti-tumor immune
response.
In a Phase 2 study of Prophage monotherapy, patients with ndGBM
exhibited an improved progression-free and overall survival as
compared to historical control with standard of care.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a
humanized monoclonal antibody that works by increasing the ability
of the body's immune system to help detect and fight tumor cells.
KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1
and PD-L2, thereby activating T lymphocytes which may affect both
tumor cells and healthy cells. KEYTRUDA is indicated for the
treatment of patients with unresectable or metastatic melanoma; for
the first-line treatment of patients with metastatic non-small cell
lung cancer (NSCLC) whose tumors have high PD-L1 expression (TPS
≥50%) as determined by an FDA-approved test, with no EGFR or ALK
genomic tumor aberrations and upon disease progression on or after
platinum-containing chemotherapy in patients with NSCLC whose
tumors express PD- L1 (TPS ≥1); and for the treatment of patients
with recurrent or metastatic head and neck squamous cell carcinoma
(HNSCC) with disease progression on or after platinum-containing
chemotherapy. KEYTRUDA is administered as an intravenous
infusion every three weeks for the approved indications.
For Safety and Prescribing Information for KEYTRUDA
(pembrolizumab), please see
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
About Agenus
Agenus is a clinical-stage
immuno-oncology company focused on the discovery and development of
novel therapies that engage the body's immune system to fight
cancer. The Company's vision is to expand the patient populations
benefiting from cancer immunotherapy by pursuing a number of
combination approaches that leverage a broad repertoire of antibody
therapeutics and proprietary cancer vaccine platforms. The Company
is equipped with a suite of antibody discovery platforms and a
state-of-the-art GMP manufacturing facility with the capacity to
support pre-commercial clinical programs. Agenus is based in
Lexington, MA. For more
information, please visit www.agenusbio.com; information that may
be important to investors will be routinely posted on our
website.
About Merck
For 125 years, Merck has been a global
health care leader working to help the world be well. Merck is
known as MSD outside the United
States and Canada. Through
its prescription medicines, vaccines, biologic therapies, and
animal health products, Merck works with customers and operates in
more than 140 countries to deliver innovative health solutions.
Merck also demonstrates its commitment to increasing access to
health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with Merck on Twitter, Facebook, YouTube and LinkedIn.
About BTTC
BTTC was created as a network of medical
centers with the expertise and strong desire to participate in
state-of-the-art clinical trials investigating new treatments for
malignant brain tumors. Several additional brain cancer-focused
medical centers have since joined the BTTC. These institutions will
allow patients across a broad geographic range to participate in
cutting-edge clinical trials and more rapidly determine the
benefits of various therapies.
Forward Looking Statements
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 Company's product candidates and
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.
Contact:
Agenus Inc.
Michelle Linn, 781-674-4541
michelle.linn@agenusbio.com
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SOURCE Agenus Inc.