On April 5, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, reported receipt of a $5M clinical milestone payment for AGEN2373 (conditionally active CD137 agonist) (Press release, Agenus, APR 5, 2022, View Source [SID1234611464]). AGEN2373 is being evaluated in a Phase 1b combination study with botensilimab (Fc-enhanced anti-CTLA-4), in melanoma patients who had relapsed on, or were refractory to, prior anti-PD-1 therapy.
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"The majority of patients treated with anti-PD-1 progress within a year and are in need of more effective treatment options," said Steven O’Day, MD, Chief Medical Officer of Agenus. "Botensilimab has shown promising activity in a wide range of treatment-resistant cancers, including melanoma. The rationale to combine botensilimab and AGEN2373 is based on preclinical evidence we reported of enhanced tumor control with this approach in a PD-1 resistant melanoma model. This study represents a rationally designed combination strategy to bring novel therapies to cancer patients."
AGEN2373 has demonstrated preliminary clinical benefit and has been well tolerated without signs of liver toxicity, an adverse event that has impacted competitor antibodies in the clinic. Gilead currently has an exclusive option to license AGEN2373. Agenus retains the right to opt-in to share Gilead’s development and commercialization costs in the United States in exchange for a 50:50 profit share and US co-commercialization rights.
References
A. Tolcher et al., 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. Presented at the ASCO (Free ASCO Whitepaper) 2021 Virtual Meeting.
C. Galand et al., AGEN2373 is a CD137 agonist antibody designed to leverage optimal CD137 and FcγR co-targeting to promote antitumor immunologic effects. Presented at the SITC (Free SITC Whitepaper) 2020 Virtual Meeting.
About AGEN2373
AGEN2373 is a fully human monoclonal antibody designed to boost the immune response to cancer cells by enhancing CD137 co-stimulatory signaling in activated immune cells. The unique binding properties of AGEN2373 are expected to limit its activity outside of the tumor site and mitigate toxicities that may be associated with systemic activation of CD137 in humans.
About Botensilimab
Botensilimab (also known as AGEN1181) is a next-generation, Fc-enhanced, immunoglobulin G1 (IgG1) antibody designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) inhibitory function from interacting with its ligands CD80 and CD86. The Fc region of the antibody was engineered to enhance immune activation and tumor killing, improve safety, and benefit a broader patient population versus first-generation anti CTLA-4 antibodies. CTLA-4 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.