May 18, 2021

ET0038, a highly potent and selective allosteric inhibitor of SHP2, received U.S. FDA IND approval

Today ETERN, a global biotech company focusing on developing novel technology targeting protein dynamics to drug “undruggable” targets, announced that its innovative anti-tumor small-molecule drug ET0038 has obtained the IND “STUDY MAY PROCEED” letter from the U.S. FDA.

ET0038 is an allosteric inhibitor of SHP2 developed in-house by ETERN, which holds worldwide rights. It is intended to be used in clinical research on advanced solid tumors. Meanwhile, IND application in China has been accepted by the National Medical Products Administration (NMPA). Clinical trials of ET0038 are expected to be carried out simultaneously in China and the United States soon.

SHP2, encoded by PTPN11, is a Src homology-2 domain-containing protein tyrosine phosphatase-2. It promotes the occurrence and development of tumors by regulating multiple signal transduction. ET0038 specifically inhibits SHP2 and is expected to provide a new treatment option for advanced solid tumors.

At the American Association for Cancer Research (AACR) annual meeting last month, ETERN released important ET0038 preclinical data, which attracted many attentions. Studies have shown that ET0038 selectively and potently inhibits the activity of SHP2 tyrosine phosphatase, and shows 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.

Translational medicine studies have also shown that ET0038 and a variety of drugs that target the RTK/RAS pathway or cell cycle regulation have significant synergistic anti-tumor effects, and also have a synergistic effect against EGFR C797S mutation or cMET-amplification induced osimertinib-resistant tumors.

Dr. Jidong Zhu, Co-founder and CEO of ETERN, said “"ET0038's IND approval from the U.S. FDA is a major milestone for us to move from preclinical to clinical in just two and a half years of establishment. We hope to use translational medicine-driven clinical strategies while actively explore combination options to bring new and effective treatment for cancer patients. At the same time, the company will continue to actively develop more global first-in-class products targeting "undruggable" targets to benefit 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.