Antengene Announces HREC Approval in Australia

07 February 2022 | Monday | News

For the Phase I Trial of the Small Molecule CD73 Inhibitor ATG-037 English
Image Source : Public Domain

Image Source : Public Domain

ATG-037 is the first orally-available, small molecule CD73 inhibitor to advance to clinical-stage by a Chinese company
- The Phase I study will evaluate ATG-037 as a monotherapy or in combination with an immune checkpoint inhibitor to determine the safety, pharmacology and preliminary signal of activity in patients with locally advanced or metastatic solid tumors

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative 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 ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037.


ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with CPIs and chemotherapy agents. In preclinical studies, the compound has demonstrated to overcome the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound will have a broad therapeutic window.

Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "Developing novel molecules that can make a clinical difference in cancer is of paramount importance to Antengene. Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors."

Dr. Lynch continued, "While we remain very interested to explore the drug as a monotherapy, combination therapy of ATG-037 with CPIs and chemotherapies could enable synergistic improvements in tumor response for patients with advanced and metastatic cancers.  ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programs. I'm very excited about the start of the clinical program and look forward to next steps with ATG-037."

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