-ATG-037 is an oral small molecule CD73 inhibitor from Deqi Pharmaceutical. KEYTRUDA® (Pbolizumab) is a PD-1 inhibitor of Merck.
- This clinical collaboration is designed to evaluate ATG-037 alone and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors.
- The trial has enrolled patients in the monotherapy portion of ATG-037 in the second quarter of 2022 and will start in combination with KEYTRUDA® in 2023.
According to the wechat account of Deqi Pharmaceutical, Deqi Pharmaceutical Co., Ltd. announced on December 27 that it has entered into a global clinical cooperation with Merck (Merck's corporate name in Rohway, New Jersey, USA). Will co-conduct a multicenter, open, Phase I dose-exploration study (STAMINA-001 trial) to evaluate ATG-037 monotherapy and KEYTRUDA® (PD-1 inhibitor) in combination with Merck for the treatment of patients with locally advanced or metastatic solid tumors.
The primary purpose of the STAMINA-001 study was to assess the safety and tolerability of ATG-037 monotherapy and KEYTRUDA® in combination with Keytruda ® in order to confirm dosages for the Phase II trial. The secondary objective was to understand the pharmacological characteristics and preliminary efficacy of ATG-037. Under the terms of the agreement, Deki will conduct the trial and Merck will provide KEYTRUDA® as required for the combination therapy portion of the trial.
ATG-037 is an innovative drug authorized by Calithera and independently developed by Deqi Pharmaceutical with global interests. As the first oral CD73 small molecule inhibitor to enter the clinical stage in China and the Asia-Pacific region, ATG-037 has been approved for clinical use in Australia and China and has started patient recruitment in Australia.
Ms. Zhang Xiaojing, Chief Medical Officer of Deqi Pharmaceutical, said, "Deqi Pharmaceutical believes that the right combination of tumor immunological drugs and targeted drugs is expected to significantly improve treatment outcomes for cancer patients. ATG-037's effect on adenosine-producing CD73 reverses immunosuppression in the tumor microenvironment, suggesting that the drug may provide better clinical benefits in combination with multiple tumor immunotherapies. We are excited about the opportunity to explore the clinical potential of ATG-037 monotherapy and KEYTRUDA® in combination with Merck, which is currently enrolling patients in the STAMINA 001 study in Australia. We hope that this study will provide the basis for further exploration of treatments for many types of cancer and lead to positive improvements in the current state of cancer treatment."
Dr. Jianming Mei, Founder, Chairman and Chief Executive Officer of Deqi Pharmaceuticals, said, "For Deqi Pharmaceuticals, the exploration of novel combination therapies that combine pipeline drugs with immunotherapy drugs or other drugs with specific mechanisms of action is one of the company's core strategies for developing breakthrough oncology therapeutics. "This partnership with Merck is exciting and represents another major step in our journey to achieve our vision of 'medicine without frontiers, innovation for all.'"
KEYTRUDA® is a registered trademark owned by Merck & Co., Inc., of Rohway, New Jersey, USA. Merck Sharp & Dohme LLC.
About ATG-037
ATG-037 is an oral small molecule inhibitor of CD73. CD73 interferes with the antitumor immune response by producing adenosine, which induces immunosuppression in the tumor microenvironment. In preclinical studies, ATG-037 alone and in combination with immunocheckpoint inhibitors (ICI) or chemotherapeutic agents showed promising antitumor activity. Preclinical studies have also shown that the drug can overcome the "hook effect" commonly seen in anti-CD73 antibody drug therapy. In addition, GLP toxicology studies have shown a wide therapeutic window.
