Antengene Administers First Patient in US Clinical Study of ATG-017 for Advanced Solid Tumors with Nivolumab Combination

18 July 2023 | Tuesday | News

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that the first patient has been dosed in the United States in the combination portion of the Phase I ERASER trial to evaluate ATG-017 plus nivolumab. The objective of the combination segment of the study is to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of ATG-017 combination therapy with nivolumab in patients with advanced solid tumors.
Image Source : Public Domain

Image Source : Public Domain

-  ATG-017 is an oral, potent and selective small molecule ERK1/2 inhibitor. Antengene has exclusive global rights to develop, commercialize, and manufacture ATG-017
-  The combination portion of the ERASER study, the first-in-human (FIH) study of ATG-017, was designed to evaluate the safety/tolerabilitypharmacokinetics, and preliminary efficacy of ATG-017 combination therapy with nivolumab in patients with advanced solid tumors
-  The monotherapy portion of the ERASER study is currently ongoing in Australia while the combination portion will be carried out in parallel in both the U.S. and Australia


ATG-017 is an oral, potent, and selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. The clinical collaboration between Antengene and Bristol Myers Squibb (BMS) to evaluate ATG-017 in combination with nivolumab (the ERASER study) builds on Antengene's preclinical data which have demonstrated that the combination of an ERK1/2 inhibitor and an immune checkpoint inhibitor (ICI) worked synergistically to produce improved efficacy in preclinical ICI-resistant in vivo murine models. 

"We are pleased that the first patient in the combination cohort of the ERASER study of ATG-017 in the US has been dosed. Meanwhile, the monotherapy segment of the study is progressing well as planned in Australia," said Dr. Amily Zhang, Antengene's Chief Medical Officer. "Based on the the preclinical data of ATG-017 that showed highly specific selectivity and promising activity, as well as synergistic effects in combination with ICIs, we are confident in ATG-017's potential as a best-in-class ERK1/2 inhibitor and look forward to continuing to advance this clinical program of ATG-017." 

"Having the first patient dosed in the combination portion of this study of ATG-017 in the U.S. marks another milestone in the development of the drug candidate. We have high hopes for ATG-017, a small molecule ERK1/2 inhibitor with great therapeutic potential in combination with PD-1/PD-L1 blockade or agents targeting signal pathways," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "This milestone underscores Antengene's commitment to its global innovation strategies. We will press ahead with this clinical study in efforts to bring another novel, effective and safe treatment option to cancer patients worldwide." 


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