Antengene, Bristol Myers To Evaluate ATG-017 In Combination With Opdivo In Advanced Solid Tumors

(RTTNews) - Antengene Corp. said that it has reached a clinical trial collaboration to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-017 in combination with Bristol Myers Squibb's PD-1 checkpoint inhibitor, Opdivo or nivolumab.

Antengene noted that the open-label Phase 1/2 trial will evaluate the investigational combination as a potential treatment option for patients with advanced solid tumors.

Antengene looks forward to initiating enrollment in the combination regimen in the first half of 2022.

As per the terms of the Agreement, Antengene will sponsor and fund the study and Bristol-Myers Squibb will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Antengene has global commercial and development rights to ATG-017. Opdivo is a trademark of Bristol-Myers Squibb Company.

ATG-017 is an oral and selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells.

The collaboration builds on Antengene's preclinical data set, which showed that the combination of an ERK1/2 inhibitor and an immune checkpoint inhibitor (CPI) worked synergistically to produce improved efficacy in preclinical immune CPI-resistant cancer models.

ATG-017 is currently being investigated in a Phase 1/2 open-label, multicenter dose-finding study, the "ERASER" study, in patients with identified mutations in the RAS-MAPK pathway. The trial is being conducted in two parts, with dose-escalation and dose-expansion parts exploring both monotherapy and as a combination therapy, with a PD-1 checkpoint inhibitor as the first partner drug.