Agenus Presents New Data on Balstilimab and AGEN2373 in ASCO Abstracts
May 20 2021 - 7:00AM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of checkpoint antibodies, cell therapies, adjuvants, and
vaccines designed to activate immune response to cancers and
infections, today announced data on the differentiated activity
profile of balstilimab, an anti-PD-1 antibody, and new Phase 1
clinical data for AGEN2373, a CD137 agonist antibody, as published
in abstracts for two posters to be presented at the American
Society for Clinical Oncology (ASCO) Annual Meeting 2021 from June
4 – 8, 2021.
Balstilimab has shown expanded clinical activity in a Phase 2
clinical trial for patients with recurrent or metastatic cervical
cancer. Responses have been observed in both PD-L1 positive and
PD-L1 negative tumors in contrast to approved anti-PD-1 antibodies
which have shown almost no responses in the PD-L1 negative
population. Preclinical observations using the company’s
proprietary platform corroborate these results, showing
differentiated activity and superior tumor killing potential for
balstilimab as compared to commercially available anti-PD-1
antibodies.
Agenus submitted a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) on April 19 for the use of
balstilimab in patients with recurrent or metastatic cervical
cancer. This submission was based on data from the Phase 2 trial
showing a response rate of 20% in PD-L1 positive tumors and an
overall response rate of 15% with a median duration of response of
15.4 months.
AGEN2373 is a conditionally active CD137 agonist antibody
designed to overcome limitations seen with first-generation CD137
agonist antibodies, including the development of liver toxicity. In
this first-in-human study of AGEN2373 in patients with advanced
solid tumors, no dose limiting toxicities were seen at doses up to
3 mg/kg; notably, no liver toxicity has been observed. Five
patients demonstrated stable disease out of 19 patients treated
with AGEN2373 monotherapy, including one heavily pretreated patient
with metastatic leiomyosarcoma who had progressed on prior
combination checkpoint immunotherapy.
“We are encouraged by the differentiated qualities of our
anti-PD-1 balstilimab both in the clinic and in preclinical
models,” said Steven O’Day, MD, Chief Medical Officer at Agenus.
“Our novel CD137, AGEN2373, has been well tolerated in this dose
escalation trial and we look forward to advancing it into
combinations for potential benefit to patients.”
Presentation Details:
Abstract title: Differentiated activity profile
for the PD-1 inhibitor balstilimabAbstract number:
5529Poster Session: Gynecologic
CancerPresenting author: Cailin Joyce, PhD
Abstract title: Initial findings of the
first-in-human Phase I study of AGEN2373, a conditionally active
CD137 agonist antibody, in patients (pts) with advanced solid
tumorsAbstract number: 2634Poster
Session: Developmental
Therapeutics—ImmunotherapyPresenting author:
Anthony Tolcher, MD
The 2021 ASCO Annual Meeting will take place on June 4 – 8,
2021.
About balstilimabBalstilimab is a novel, fully
human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1
(programmed cell death protein 1) from interacting with its ligands
PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation
that is considered a foundational target within the immuno-oncology
market. Balstilimab is currently in clinical trials as monotherapy
and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an
ongoing Phase 2 study for recurrent/metastatic cervical cancer.
A Biologics License Application has been submitted to the U.S.
Food and Drug Administration for the use of balstilimab to treat
recurrent/metastatic cervical cancer.
About AGEN2373AGEN2373 is a novel, fully human
monoclonal conditionally active CD137 agonist antibody designed to
selectively enhance CD137 co-stimulatory signaling in activated
immune cells while mitigating side effects associated with systemic
activation of CD137. CD137 (4-1BB) is a positive regulator of the
immune system that is highly upregulated on activated T cells
(adaptive immune cells) and NK cells (innate immune cells).
AGEN2373 is advancing in a Phase 1 clinical trial against solid
tumors.
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 future clinical development plans for AGEN2373
alone and in combination with other agents. 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.
ContactAgenus Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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