Antengene and Merck (MSD) have entered into a global clinical collaboration to assess the former’s oral small molecule CD73 inhibitor, ATG-037 as a monotherapy and along with the latter’s Keytruda (pembrolizumab) in a Phase I study.
Under the alliance, the companies will carry out an open-label, multicentre Phase I dose-finding study (STAMINA-001 study) of ATG-037 along with Keytruda in locally advanced or metastatic solid tumour patients.
The STAMINA-001 study’s primary objective is to assess the tolerability and safety of ATG-037 as a single agent and along with Keytruda for determining the suitable dose for Phase II studies.
Characterisation of the pharmacology and evaluation of ATG-037’s preliminary efficacy include the secondary objectives of the trial.
As per the terms of the deal, Antengene will be responsible for conducting the study, while MSD will supply Keytruda for the trial’s combination portions.
Antengene chief medical officer Dr Amily Zhang said: “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.
“The mechanism of action of ATG-037 in inhibiting adenosine-generating CD73 is expected to reverse an immunosuppressed tumour microenvironment, thereby creating potential additive benefit with multiple immuno-oncological approaches.
“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.”
The company stated that ATG-037 has been approved to enter trials in Australia and China.
Currently, the enrolment of participants for the Phase I study of ATG-037 is underway in Australia.