Techera Pharmaceuticals and MSD Announce Global Clinical Collaboration to Evaluate ATG-037 in Combination with KEYTRUDA® for Advanced Solid Tumors

-ATG-037 is an orally available small molecule CD73 inhibitor developed by ANTENGENE CORPORATION; KEYTRUDA® (pembrolizumab) is a PD-1 inhibitor developed by MSD.

- This clinical collaboration aims to evaluate the study of ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors.

- The trial initiated patient enrollment for the ATG-037 monotherapy portion in the second quarter of 2022 and will commence the combination study with KEYTRUDA® in 2023.

According to the WeChat Official Account of Antengene Corporation, Antengene Corporation announced on December 27th that,ANTENGENE CORPORATION has reached a global clinical collaboration with MSD (MSD is the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA) to jointly conduct a multicenter, open-label, Phase I dose-finding study (STAMINA-001 trial) aimed at evaluating ATG-037 as a monotherapy and in combination with MSD’s PD-1 inhibitor KEYTRUDA® (pembrolizumab) for the treatment of patients with locally advanced or metastatic solid tumors.

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 dosing for Phase II trials. The secondary objectives are to understand the pharmacological profile and preliminary efficacy of ATG-037. According to the terms of the agreement, ANTENGENE CORPORATION will be responsible for conducting the trial, while MSD will provide the required KEYTRUDA® for the combination therapy portion of the trial.

ATG-037, an innovative drug licensed from Calithera and independently developed by ANTENGENE CORPORATION with global rights, is the first orally-administered small molecule CD73 inhibitor to enter clinical trials in China and the Asia-Pacific region. It has already been approved for clinical trials in Australia and China, and patient recruitment has commenced in Australia.

Dr. Zhang Xiaojing, Chief Medical Officer of ANTENGENE CORPORATION, stated:"ANTENGENE CORPORATION believes that the rational combination of cancer immunotherapy drugs and targeted therapy drugs has the potential to significantly improve treatment outcomes for cancer patients. ATG-037’s inhibitory effect on CD73, which produces adenosine, can reverse immunosuppression in the tumor microenvironment, implying that this drug, when combined with various cancer immunotherapies, may offer greater clinical benefits. We are excited to explore the clinical potential of ATG-037 as a monotherapy and in combination with MSD’s KEYTRUDA®. Currently, ANTENGENE CORPORATION is recruiting patients in Australia for the STAMINA-001 study. We hope this research will provide a basis for further exploration in treating various cancers and bring positive improvements to the current state of cancer therapy."

Dr. James Mei, Founder, Chairman and CEO of Antengene Corporation, said:"For ANTENGENE CORPORATION, exploring novel combination therapies consisting of pipeline drugs with immunotherapy drugs or other drugs with unique mechanisms of action is one of the company's core strategies for developing breakthrough cancer treatments. This collaboration with MSD is truly exciting, marking another significant step forward in our journey toward realizing the vision of 'Boundless Medicine, Endless Innovation.'"

KEYTRUDA® is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. located in Rahway, New Jersey, USA.

About ATG-037

ATG-037 is an orally available small-molecule inhibitor of CD73. CD73 can interfere with anti-tumor immune responses by generating adenosine, leading to immunosuppression within the tumor microenvironment. In preclinical studies, ATG-037 as a monotherapy and in combination with immune checkpoint inhibitors (ICIs) or chemotherapy drugs demonstrated favorable anti-tumor activity. Preclinical studies also showed that the drug could overcome the "hook effect" commonly observed in anti-CD73 antibody drug treatments. Additionally, non-clinical Good Laboratory Practice (GLP) toxicology studies indicated a wide therapeutic window for the drug.

About ANTENGENE CORPORATION

Antengene Corporation (referred to as "Antengene", Hong Kong Stock Exchange stock code: 6996.HK) is a leading biopharmaceutical company driven by research and development that has entered the commercialization stage. With the vision of “No Borders in Medicine, Innovation for Eternity,” Antengene focuses on the early-stage R&D, clinical research, drug manufacturing, and commercialization of first-in-class and best-in-class therapies in the fields of hematology and solid tumors. Dedicated to improving the quality of life for patients worldwide through breakthrough treatments.

Since 2017, Antengene Corporation has built an expanding pipeline comprising 13 clinical and preclinical products, of which 10 products have global rights and three products have Asia-Pacific rights, including Greater China. The company has obtained 27 clinical trial approvals (INDs) in the United States and multiple Asia-Pacific markets and submitted nine new drug applications (NDAs). Currently, Xpovio® (selinexor tablets) has received new drug approval for marketing in China, Taiwan, South Korea, Singapore, and Australia.

Editor: Dadasiva

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