Agenus Presents Positive Efficacy and Safety Outcomes for AGEN2373 at ASCO
June 05 2023 - 9:49AM
Business Wire
- AGEN2373 is the first CD137 agonist antibody reporting single
agent responses with no major toxicity
- Responses reported in patients with prostate cancer, ampullary
carcinoma and metastatic vulvar squamous cell carcinoma
- No hepatic toxicities, grade ≥3 treatment-related adverse
events, or dose-limiting toxicities were observed at doses up to 10
mg/kg
Agenus (Nasdaq: AGEN), a leading immuno-oncology company with a
pipeline of immunological agents targeting cancer and infectious
disease, presented complete results from the monotherapy arm of the
first-in-human dose escalation study of AGEN2373 (CD137 agonist) at
the American Society of Clinical Oncology (ASCO) Annual Meeting.
AGEN2373 demonstrated objective responses, clinical benefit, and
was well tolerated in heavily pre-treated patients with solid
tumors.
“AGEN2373 has shown meaningful single agent activity and a
favorable safety profile without evidence of liver toxicity in
patients with heavily pretreated cold and immunotherapy resistant
tumors,” said Dr. Steven O’Day, MD, Chief Medical Officer at
Agenus. “AGEN2373 is designed to selectively boost tumor immunity
while limiting hepatotoxicity and off-target effects associated
with systemic CD137 activation. These encouraging monotherapy
results support further clinical trials for AGEN2373 alone and in
combination with our novel immunotherapy programs.”
Study Design:
AGEN2373 was administered intravenously at doses ranging from
0.03 mg/kg to 10 mg/kg in a cohort of 46 patients with advanced
solid tumors and a median of 4 prior lines of therapy.
Objective responses:
Notable responses in the dose escalation study include:
- Confirmed partial response in a patient with vulvar squamous
cell carcinoma who progressed on prior pembrolizumab
- Confirmed partial response with complete resolution of the
pancreatic lesion in a patient with ampullary carcinoma
- Confirmed 38% reduction in target liver lesions in a
castrate-resistant prostate cancer that was non-evaluable by RECIST
due to palliative radiation for bone metastases
Tolerability:
- No hepatic toxicities, grade ≥3 treatment-related adverse
events, or dose-limiting toxicities were observed, consistent with
the molecule’s design.
Presently, AGEN2373 is being evaluated in combination with
botensilimab (multi-functional anti-CTLA-4) at a dose of 10 mg/kg
in patients with PD-(L)1 refractory melanoma.
Presentation Details:
Abstract Title: A Phase 1 Study of AGEN2373, a Novel
CD137 Agonist Antibody Designed to Avoid Hepatoxicity, in Patients
with Advanced Solid Tumors (NCT04121676)
Abstract Number: 2524
Poster Number: 366
Presenting Author: Dr. Minal Barve, MD, Executive
Director and Chief Medical Officer, Mary Crowley Research
The poster presentation can be accessed in the publications
section of our website at https://agenusbio.com/publications/.
About AGEN2373 AGEN2373 is a
novel anti-CD137 agonist designed to stimulate T and NK cells for a
durable memory response to cancer. AGEN2373’s selective binding to
a unique epitope is designed to prevent serious side effects
associated with CD137 activation in the liver, as reported by
competitor molecules.
About Agenus Agenus is a
clinical-stage immuno-oncology company focused on developing
therapies that engage the body's immune system in fighting cancer
and infections. The Company's mission is to broaden the patient
populations benefiting from cancer immunotherapy through
combination approaches, leveraging a broad repertoire of antibody
therapeutics, adoptive cell therapies (through its subsidiary MiNK
Therapeutics), and adjuvants (through its subsidiary SaponiQx).
Agenus is headquartered in Lexington, MA. For more information,
please visit www.agenusbio.com and our Twitter handle
@agenus_bio.
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 relating to the use of
AGEN2373, for instance, statements regarding therapeutic benefit
and efficacy, mechanism of action (including validation of
mechanism of action), potency, durability, and safety profile
(including the absence of specific toxicities) of the Company’s
therapeutic candidates; and any other statements containing the
words "may," "believes," "expects," "anticipates," "hopes,"
"intends," "plans," "forecasts," "estimates," "will," “establish,”
“potential,” “superiority,” “best in class,” and similar
expressions are intended to identify forward-looking statements.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230605005557/en/
Agenus Inc. Zack Armen Investor Relations (917) 362-1370
Zack.Armen@agenusbio.com
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