EN | CN

Elpiscience Announces FDA Approval of IND Application for ES002 (anti-CD39 mAb)

September 10 , 2021 12:00

Shanghai/Suzhou/Maryland, September 10, 2021. Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a global clinical-stage biopharmaceutical company focusing on discovering and developing next-generation cancer immunotherapies, today announced its investigational new drug (IND) application for ES002, an internally discovered novel antibody, has been approved by the U.S. Food and Drug Administration (FDA). A first-in-human clinical trial will be initiated in the U.S. to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES002 in patients with advanced solid tumors. 

 

“Elpiscience is dedicated to revolutionizing cancer care by turning ‘cold’ tumors ‘hot’. ES002 is our first internally developed asset that is advancing into clinical trials in the U.S. and China. Dr. Hongtao Lu, co-founder and CSO of Elpiscience, said: “With a strong drug R&D engine and technology platforms, we aim to deliver sustainable innovative molecules to cancer patients worldwide. We look forward to seeing the distinctive features of ES002 to be translated into clinical benefits.”

 

“The IND clearance for ES002 is an important milestone for Elpiscience. This represents our commitment to advancing at least one world-class molecule into the clinic each year,” said Dr. Steve Chin, CMO of Elpiscience. “We hope ES002 will provide clinical benefits to cancer patients worldwide.”

 

About ES002:

ES002 is a highly promising, potential best-in-class anti-CD39 antibody designed to promote anti-tumor immunity. CD39 is a key enzyme regulating the production of adenosine, a critical immune suppressor. By blocking CD39 function, ES002 also stabilizes pro-inflammatory extracellular ATP (eATP) and restores anti-tumor immunity within the tumor microenvironment. ES002 demonstrated highly potent single-agent anti-tumor activity in in vivo pharmacology studies. 

 

About Elpiscience:

Elpiscience is a clinical stage biopharmaceutical company focusing on innovating and developing the next generation of cancer immunotherapy. Elpiscience has developed a pipeline of globally innovative molecules, covering a wide range of targets with a particular focus on turning “cold” tumors “hot”. In addition to ES002, the company has three assets in clinical stage (ES101, ES102 and ES104). Elpiscience’s sustainable pipeline forms a strong cornerstone for developing the next generation and more effective immunotherapies. Founded and managed by seasoned executives in the biopharma industry, Elpiscience is backed by renowned investors such as Lilly Asia Ventures, Hillhouse Capital, Hyfinity Investments, Greater Bay Area Homeland Development Fund, CDH, Cormorant Asset Management and Superstring Capital. Elpiscience endeavors to advance at least one world-class molecule into the clinic each year, providing clinical benefits to cancer patients worldwide.