Agenus Launches Phase 2 Trial Expansion in Colon Cancer for AGEN1181 in Combination with Balstilimab
December 01 2020 - 8:00AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad
pipeline which includes checkpoint antibodies, cell therapies,
adjuvants, and vaccines designed to activate immune response to
cancers and infections, today announced the expansion of a Phase 2
trial into colon cancer based on a new objective clinical response
in a colorectal cancer patient in addition to a significant tumor
reduction of 27% and biomarker reduction observed in a patient with
MSS colon cancer.
With this recent response in colon cancer, AGEN1181 +/-
balstilimab (anti-PD-1) has reported 4 clinical responses plus a
significant tumor reduction of more than 27% in a fifth patient. In
addition, 19 patients have achieved disease stabilization out of 41
patients treated in what was designed as a dose escalation
study.
Recently, Agenus also presented on the first-ever report of
intratumoral Treg depletion with a CTLA-4 antibody in clinical
trials. The summary of responses achieved with AGEN1181 alone or in
combination with balstilimab are as follows:
- CR in PD-L1(-) MSS
endometrial cancer patient (1181 monotherapy)
- CR in PD-L1(-) MSS
endometrial cancer patient (1181 + bali)
- PR
in a colorectal cancer patient (1181 + bali)
- PR in PD-L1(-)
refractory ovarian cancer patient (rescued with 1181 + bali) –
previous stable disease for 66 weeks with 1181 monotherapy
- Major tumor
reduction (27%) in MSS colorectal cancer with remarkable
CEA biomarker reduction from 298 to 2 (1181 + bali)
In the phase 1 trial of AGEN1181, clinical benefit and responses
have been seen in patients with polymorphism in FcyRIIIA alleles
who are not responsive to first-generation CTLA-4 antibodies.
The Phase 2, open-label, multicenter study will focus primarily
on colorectal cancer and select solid tumors, such as lung cancer
and melanoma.
“These early data are very exciting, particularly in aggressive
tumors that have traditionally been unresponsive to immune
therapies, like colorectal cancer,” said Dr. Joseph Grossman,
expert in gastrointestinal cancers and the Head of Exploratory
Medicine at Agenus. “AGEN1181 has potential to not only broaden the
population of responders to CPIs, but also to reach tumors
traditionally considered “cold” or unresponsive to immune
therapies. I am excited to see the potential broadened benefit of
our next-generation anti-CTLA-4’s design, particularly its
Fc-enhancement, and the validation of Agenus’ incredible R&D
capabilities.”
Dr. Joseph Grossman recently joined Agenus as head of
exploratory medicine from Harvard Medical School, where he was an
instructor in medicine, and Beth Israel Deaconess Medical Center,
where he served as an attending physician in GI oncology. He
completed his residency and fellowship in hematology oncology at
Beth Israel Deaconess Medical Center. He holds a postbaccalaureate
certificate in premedical sciences from Columbia University in the
City of New York and an MD from Brown Medical School.
About AgenusAgenus is a clinical-stage
immuno-oncology company focused on the discovery and development of
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 combination approaches that
leverage a broad repertoire of antibody therapeutics, adoptive cell
therapies (through its AgenTus Therapeutics subsidiary), 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 clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com and our Twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding the therapeutic and curative potential of
AGEN1181. 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. Caroline
Bafundo212-994-8209Caroline.Bafundo@agenusbio.com
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