July 2, 2021
ET0038, a selective allosteric inhibitor of SHP2, has received the IND approval in Mainland China
ETERN, a leading biotech company focusing on developing novel technology targeting protein dynamics to drug “undruggable” targets, announced that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase I, open-label, multicenter dose-finding study of the innovative anti-tumor drug ET0038（the FIRST study）.
The study aims to investigate the safety, pharmacokinetics, and preliminary efficacy of ET0038 in patients with advanced solid tumors with documented activating alteration of the MAPK pathway.
ET0038 is an allosteric inhibitor of SHP2 developed in-house by ETERN, which holds worldwide rights. In preclinical studies, it showed highly effective anti-tumor activity in a variety of tumor models that carry oncogenic mutations in the RTK/RAS pathway, including NSCLC, pancreatic cancer, esophageal cancer, and gastric cancer, etc. ET0038 received the IND approval from the U.S. FDA in May 2021. Clinical trials will be carried out in China and the U.S. simultaneously.
Dr. Jidong Zhu, Co-founder and CEO of ETERN, said “This IND approval from the NMPA marks an important step for ETERN’s clinical development. Based on the compelling preclinical data, ET0038 has the potential to improve the current treatment status for patients with advanced solid tumors in China and bring new effective treatment options to these patients."
About ETERN Therapeutics
ETERN was established in October 2018 and focuses on developing novel technology targeting protein dynamics to drug “undruggable” targets. ETERN has developed two proprietary technology platforms - Protein Dynamic Structure (DSP) and Dynamic LLPS (Liquid-Liquid Phase Separation) Platform (DLP), built seven innovative pipelines, two of which will enter the clinical trials in the near future to provide new solutions to cancer patients.