AGEN2034 (anti-PD-1)

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.

Latest Clinical Trials

Metastatic Cervical Cancer

NCT04943627 (BRAVA)

Phase 3, open-label, randomized study with single-agent Balstilimab (BAL) or Investigator Choice (IC) chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy

Second-line cervical cancer

NCT03894215 (RaPiDS)

Randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 – monotherapy) or with AGEN1884 (Treatment Arm 2 – combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy

Second-line cervical cancer


Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen

Latest Publications and Abstracts

American Association for Cancer Research

April 8-12, 2022

AGEN1571 is a novel high-affinity ILT2 antagonist antibody that promotes adaptive and innate immune responses. Udartseva, et al.