Merck, Antengene collaborate to test Keytruda, ATG-037 combo for solid tumors in phase 1 trial
ATG-037 is an orally available, small molecule CD73 inhibitor.
Shanghai: Antengene Corporation Limited, a global biopharmaceutical company has announced that it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) on a multicenter, open-label, Phase I dose-finding study of ATG-037 as a monotherapy and in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced or metastatic solid tumors (the STAMINA-001 study).
The primary objective of the STAMINA-001 study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with KEYTRUDA, to determine the appropriate dose for Phase II studies. Secondary objectives of the study include the characterization of the pharmacology and evaluation of preliminary efficacy of ATG-037. Under the terms of the Agreement, the study will be conducted by Antengene, and MSD will provide KEYTRUDA for the combination portions of the trial.
ATG-037, is an innovative asset in-licensed from Calithera with global rights and developed in-house by Antengene, has been approved to enter clinical studies in Australia and China, thus becoming the first oral small molecule CD73 inhibitor entering the clinical-stage in China and the wider Asia Pacific region. The patient enrollment for the Phase I study of ATG-037 is currently underway in Australia.
"Antengene believes that cancer treatments involving the rational combination of immuno-oncology drugs and targeted therapies may offer the greatest opportunity for substantial advances in treatment outcomes for patients with cancer," said Dr. Amily Zhang, Antengene's Chief Medical Officer. "The mechanism of action of ATG-037 in inhibiting adenosine-generating CD73 is expected to reverse an immunosuppressed tumor microenvironment, thereby creating potential additive benefit with multiple immuno-oncological approaches. We are very excited to assess the impact of ATG-037 as a monotherapy and in combination with MSD's KEYTRUDA, and have already begun recruiting patients for the STAMINA-001 study in Australia. We hope this collaboration will generate data that allows us to proceed to later phase studies in patients with a variety of cancers, with potential for significant positive impact on treatment outcomes." continued Dr. Zhang.
"Exploring novel combinations between compounds from our portfolio with immunotherapeutic drugs or drugs with highly targeted mechanisms of action has always been Antengene's top priority towards delivering transformational cancer therapies. We are enthusiastic about the collaboration with MSD because it marks another milestone for us to fulfill our vision of 'Treating Patients Beyond Borders'," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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