Agenus Commences Phase 1 Clinical Trial of its CTLA-4 Checkpoint Antibody to Treat Solid Tumors

LEXINGTON, Mass.–(BUSINESS WIRE)–Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing
checkpoint antibodies and cancer vaccines, today announced that the
first patient has been dosed in the company’s Phase 1 clinical trial of
AGEN1884, an anti-CTLA-4 checkpoint (CPM) antibody. The open-label,
multicenter trial in patients with advanced or refractory cancer is
designed to evaluate the safety of AGEN1884 and determine the estimated
maximum tolerated dose.
“Advancing AGEN1884 into the clinic is an important milestone for
Agenus,” said Garo Armen, PhD, Chairman and CEO of Agenus. “Since the
acquisition of 4-Antibody two years ago, we have completed additional
strategic acquisitions and formed new collaborations considerably
strengthening our antibody research and development capabilities.”
AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint
antibody that enables the immune system to find and destroy cancer
cells. It is the first of a series of CPMs, discovered using Agenus’
proprietary platform, to enter clinical development. Anti-CTLA-4
antibodies have been highly efficacious in treating cancer and curative
in some patients for whom standard of care has proven unsuccessful.
Recent clinical data also suggests that anti-CTLA-4 antibodies are
emerging as a central component of combination immunotherapeutic
regimens for fighting cancer.
Agenus has in-house technologies for rapid discovery and development of
CPMs using its integrated mammalian, yeast and phage display platforms.
The company also possesses the capability to generate optimal cell lines
and manufacture GMP grade antibodies and vaccines.
“We expect additional checkpoint antibodies from our portfolio to
commence clinical trials during the course of this year. We believe our
CPMs, vaccines and adjuvants will provide advantages in advancing the
fight against cancers. This effort will be particularly enhanced by our
ability to combine these agents as required,” said Robert B. Stein, MD,
PhD, Agenus’ President, Research & Development.
This Phase 1 clinical trial is taking place at leading centers in the
United States, including The Ohio State University Comprehensive Cancer
Center and the Comprehensive Cancer Center of Northwestern University.
AGEN1884 was developed under a Collaborative Research and Development
Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta
Biopharma S.A.
About Checkpoint Antibodies
Promising clinical data from trials employing monoclonal antibodies that
bind to checkpoint molecules, such as CTLA-4 and programmed death
receptor-1 (PD-1), have generated considerable excitement in the field
of cancer immunotherapy. These molecules serve as checks employed by the
body to prevent a runaway immune response, which can be debilitating and
even deadly. Unfortunately, these necessary mechanisms of control can
hinder the anti-cancer immune response. They can be harnessed by cancer
cells as a defense against immune attack. Agenus is developing a broad
pipeline of antibodies that bind to key checkpoint proteins and activate
or block their activities for use in cancer therapy.
About Agenus
Agenus is an immuno-oncology company focused on the discovery and
development of revolutionary new treatments that engage the body’s
immune system to benefit patients suffering from cancer. By combining
multiple powerful platforms, Agenus has established a highly integrated
approach to target identification and validation, and for the discovery,
development and manufacturing of monoclonal antibodies that modulate
targets of interest. The company’s broad portfolio of novel checkpoint
modulator and other immuno-modulatory monoclonal antibodies, vaccines
and adjuvants work in combination to provide the opportunity to create
best-in-class therapeutic regimens. Agenus’ heat shock protein-based
vaccine, Prophage™, has successfully completed Phase 2 trials in
newly-diagnosed glioblastoma. The company has formed collaborations with
Merck and Incyte to discover and develop multiple checkpoint antibodies.
For more information, please visit www.agenusbio.com;
information that may be important to investors will be routinely posted
on our website.
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 plans for future clinical
trials. 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 Agenus’ Form 10-K filed with
the Securities and Exchange Commission on March 15, 2016. 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.