China-based Antengene Corporation Limited (HKG: 6996) has announced a global clinical collaboration with Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to conduct a multicenter, open-label, Phase I dose-finding study for ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab). The targeted indication is locally advanced or metastatic solid tumors, as part of the STAMINA-001 study.
Study Objectives and Design
The primary objective of the STAMINA-001 study is to evaluate the safety and tolerability of ATG-037 as a monotherapy and in combination with Keytruda to determine the appropriate dose for Phase II studies. Secondary objectives include the characterization of the pharmacology and evaluation of preliminary efficacy of ATG-037. Under the deal terms, the study will be conducted by Antengene, and MSD will provide Keytruda for the combination portions of the trial.
Drug Profile and Development
ATG-037 is an innovative asset in-licensed from Calithera by Antengene and has been approved to enter clinical studies in Australia and China. The molecule is the first oral small molecule CD73 inhibitor to enter the clinical-stage in China and the wider Asia-Pacific region. Preclinical studies have demonstrated the compound’s ability to overcome the “hook effect” observed in some anti-CD73 antibodies. Additionally, GLP toxicology studies indicate the compound potentially has a wide therapeutic window. Patient enrollment for the Phase I study of ATG-037 is currently underway in Australia.
Future Prospects and Strategic Implications
The collaboration with MSD marks a significant step for Antengene in advancing ATG-037 through clinical development. By leveraging MSD’s expertise and resources, Antengene aims to expedite the evaluation and potential approval of ATG-037 for the treatment of locally advanced or metastatic solid tumors, addressing significant unmet medical needs in oncology.-Fineline Info & Tech
