Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation cancer immunotherapies, today announced that the first patient has been dosed in a Phase 1/2 clinical study, evaluating the safety, tolerability, preliminary anti-tumor efficacy and pharmacokinetics of ES104 for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC) in China. ES104 is a bispecific antibody that simultaneously blocks the Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways that are critical to angiogenesis and tumor vascularization.
In prior clinical testing, ES104 demonstrated significant anti-tumor activity in patients who had failed multiple lines of therapy and were considered resistant to currently approved anti-VEGF therapies. Elpiscience received Center of Drug Evaluation (CDE) IND clearance for ES104 in October 2021. ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.
“We are excited to initiate this Phase 1/2 clinical study of ES104. In a recent Phase 1 study, ES104 showed single-agent activity in advanced gastric cancer and CRC patients who were considered treatment resistant to anti-VEGF containing regimens,” said Steve Chin, CMO of Elpiscience. “We look forward to the potential therapeutic benefit of ES104 for the treatment of CRC patients in China.”
For more information on the Phase 1/2 clinical study, refer to Clinicaltrials.gov identifier NCT05167448.
ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed greater China rights to ES104 in January 2021.