PD-1 (programmed cell death protein 1) is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. In 2018, the Nobel Prize in Medicine was awarded for the establishment of PD-1 as a cancer immunotherapy target. Agenus has applied these scientific principles to create a therapy designed to treat cancer, AGEN2034.
AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2.
AGEN2034 is clinically active in patients with advanced or refractory cancer.
In August 2021, Agenus announced the publication of results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer in the international peer reviewed journal Gynecologic Oncology. In the 140 evaluable patients, overall response rate (ORR) was 15%, disease control rate (DCR) was ~50% and the median duration of response was 15.4 months. In the 85 evaluable patients with PD-L1 positive tumors, an ORR of 20% was achieved.
Agenus controls worldwide rights to AGEN2034, except for certain South American rights, which are controlled by Recepta Biopharma, and Greater China rights, which are exclusively licensed to Betta Pharmaceuticals.