Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule ATR Inhibitor ATG-018
Tuesday, June 07, 2022
Antengene Corporation Limited, a leading commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that Antengene has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I Trial of ATG-018 in patients with advanced solid tumors and hematologic malignancies (ATRIUM Trial).
ATG-018 is an orally-available, potent, selective small molecule ATR inhibitor. ATG-018 inhibits the ATR kinase, thus limiting cancer cells' ability to repair damaged DNA, in a mechanism also known as synthetic lethality or the DDR.
The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as a monotherapy, to determine the appropriate dose for Phase II studies and assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018. The study will be conducted in two parts (dose-escalation and dose-expansion). Icon Brisbane in Australia is the lead site for the study, which will be conducted at five sites across Australia.
"DNA is constantly exposed to damage by sources such as ultraviolet light, toxins, certain chemicals, and natural biochemical processes inside our cells. The DNA damage response (DDR) is able to identify DNA damage and to induce various biological processes that correct these changes." Said Dr Jim Coward, Chair of Icon's Medical Oncology Research Committee and Associate Professor at University of Queensland School of Medicine. "The therapeutic landscape of antitumor agents targeting DDR pathways has rapidly expanded to include inhibitors of other key mediators of DNA repair and replication, such as ATR, ATM and DNA-PK[1]. Positive findings from the trials evaluating ATR inhibitors such as ATG-018 may help provide oncologists with a new tool for improving patient outcomes in challenging cases and give them new hope when other therapies have failed."
Dr. Bo Shan, Antengene's Chief Scientific Officer commented, "ATG-018 has a solid preclinical data package including efficacy as a monotherapy in solid tumor models, oral bio-availability and potential predictive biomarkers for response. It is also one of Antengene's first in-house programs to reach the clinic. The differentiated profile of ATG-018 may enable it to be used as monotherapy and open the door for novel collaborations and combination regimens that could benefit cancer patients around the world. We are very pleased to receive HREC approval for the Phase I ATRIUM trial for ATG-018 and we look forward to collaborating with Dr. Coward and the team at Icon Brisbane on this exciting trial."
