Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation cancer immunotherapies, today announced that the Center of Drug Evaluation (CDE) has cleared Elpiscience’s Investigational New Drug Application (IND) for ES002 to initiate a Phase I clinical trial in China.
ES002 is a proprietary anti-CD39 monoclonal antibody (mAb), which has demonstrated highly potent single-agent anti-tumor activity showing a significant reduction in tumor size in in vivo pharmacology studies.
“We are delighted that our IND application for ES002 is approved by the CDE, which follows the earlier IND and Phase I clinical study initiation in the US，” said Dr. Steve Chin, CMO of Elpiscience. “Robust preclinical data suggests that our anti-CD39 mAb has a potential best-in-class profile, including a strong effect on T cell function and superior enzymatic inhibition. We look forward to initiating the study in China and potential clinical benefits ES002 may offer for patients with solid tumors worldwide.”
ES002 is an anti-CD39 mAb 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 and is currently in a Phase 1 clinical trial in the US (NCT05075564).[JC1]
Elpiscience is a clinical stage biopharmaceutical company focused on innovating and developing next-generation immunotherapy. The company has a robust pipeline of globally innovative molecules, covering wide range of targets in immuno-oncology. It has four molecules in clinical trials, including ES104, ES101, ES102, and ES002. Founded and managed by a team of biopharma industry leaders and scientists, Elpiscience is backed by renowned investors including, Lilly Asia Ventures, Hillhouse Capital, Hyfinity Investments, Greater Bay Area Homeland Development Fund, CDH, DYEE Capital and Cormorant Asset Management. Elpiscience endeavors to advance at least one innovative molecule into the clinic each year to benefit cancer patients worldwide.