BALSTILIMAB

Balstilimab (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.

Agenus’ PD-1 is in clinical trials as monotherapy and in combination with our CTLA-4, AGEN1884 in an ongoing Phase 1/2, open-label, multi-arm trial to investigate the safety, tolerability, pharmacokinetics, as well as biological and clinical activity of this regimen in patients with metastatic or locally advanced solid tumors including refractory cervical cancer. As of April 2020, our anti-CTLA-4 antibody in combination with our anti-PD-1 antibody has achieved 14 positive clinical responses in 55 patients with second-line cervical cancer (~26% ORR with ~12-month follow-up).

Latest Clinical Trials

Enrolling in second-line cervical cancer

NCT03104699

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

Enrolling in second-line cervical cancer

NCT03894215

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

Latest Publications and Abstracts

Society for Immunotherapy of Cancer (SITC)

November 6-10, 2019

Single-agent Activity of a Novel PD-1 Inhibitor, AGEN2034, in Recurrent Ovarian Cancer. O’Malley, et al.

European Society for Medical Oncology (ESMO)

October 19-23, 2018

Phase 1/2, Open-Label, Multiple Ascending Dose Trial of AGEN2034, an Anti–PD-1 Monoclonal Antibody, in Advanced Solid Malignancies: Results of Dose Escalation in Advanced Cancer and Expansion Cohorts in Subjects With Relapsed/Refractory Cervical Cancer. Drescher, et al.

European Society for Medical Oncology (ESMO)

October 19-23, 2018

Phase 1/2 Study of CTLA-4 Inhibitor AGEN1884 + PD-1 Inhibitor AGEN2034 in Patients With Advanced/Refractory Solid Tumors, With Expansion Into Second-Line Cervical Cancer and Solid Tumors. Coward et al.

American Society of Clinical Oncology (ASCO)

June 1-5, 2018

Phase One Open-Label, Ascending Dose Trial of AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Advanced Solid Malignancies: Results of Dose Escalation. Moore, et al.

American Association for Cancer Research (AACR)

April 14-18, 2018

Evaluation of Peripheral T Cell Subset Proliferation as a Pharmacodynamic Assay to Guide the Development of Anti-CTLA-4 and PD-1 Antibody Combinations in Patients With Solid Tumors. de Souza, et al.

Society for Immunotherapy of Cancer (SITC)

November 9-12, 2017

AGEN2034, a Novel anti-PD-1 Antibody that Combines Effectively With CTLA-4 Pathway Blockade to Enhance T Cell Activity. Chand, et al.