2022-12-27| ChinaPartnerships

Antengene To Pair CD73 Inhibitor With Merck’s Keytruda In Clinical Collaboration

by Joy Lin
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Shanghai, China-based Antengene is teaming up Merck (known as MSD outside the US and Canada) to test the synergy between ATG-037, an oral small molecule CD73 inhibitor, and Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, against locally advanced or metastatic solid tumors. 

The clinical collaboration includes a Phase 1 dose-finding study (Stamina-001) of ATG-037 as a monotherapy and in combination with Keytruda. 

Antengene’s ATG-037 was in-licensed from American biopharma Calithera in 2021. The agreement included an undisclosed upfront payment and potential milestones and royalties in exchange for worldwide rights to the CD73 inhibitor. 

The drug, which is now being developed in-house by Antengene, has since become the first of its kind to enter clinical trials in China and the Asia Pacific region, with patient enrollment for the Stamina-001 study underway in Australia. 

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Laying The Groundwork For Combining ATG-037 And Keytruda

In the Phase 1 Stamina-001 study, the companies will evaluate the safety and tolerability of AT-037 as a monotherapy and in combination with Keytruda, and determine the right dosage for Phase 2 studies. 

The study investigators also aim to characterize the pharmacology and evaluate the preliminary efficacy of ATG-037. The study itself will be conducted by Antengene, while Merck will provide Keytruda for the combination arm of the trial. 

ATG-037 is designed to inhibit CD73. CD73 generates adenosine, which has immunosuppressive effects such as inhibiting T-cell toxicity in the tumor microenvironment. 

The small molecule has been shown to bypass the “hook effect”, which results in inaccurately low results of a tumor biomarker in immunoassays. 

Preclinical studies of ATG-037 suggest promising efficacy as a monotherapy or in combination with immune checkpoint inhibitors or chemotherapy. Toxicology studies also suggest the drug has a wide therapeutic window. 

“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,” said Dr. Amily Zhang, Antengene’s Chief Medical Officer. 

“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,” added Dr. Zhang.

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