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.
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
Presentation Details:
Abstract title: Differentiated activity profile for the PD-1 inhibitor balstilimab
Abstract number: 5529
Poster Session: Gynecologic Cancer
Presenting author:
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 tumors
Abstract number: 2634
Poster Session: Developmental Therapeutics—Immunotherapy
Presenting author:
The 2021 ASCO Annual Meeting will take place on
About balstilimab
Balstilimab 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
About AGEN2373
AGEN2373 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
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 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
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