Elpiscience Announces First Patient Dosed in Phase 1/2 Clinical Study of ES104 for Treatment of Colorectal Cancer

SHANGHAI & SUZHOU, China & GERMANTOWN, Md.–(BUSINESS WIRE)–#CRCSM–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, pharmacokinetics and preliminary anti-tumor efficacy 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) INC 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.

About ES104:

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.

About Elpiscience:

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.

Learn more at elpiscience.com

Contacts

Investor inquiries:
Elpiscience, Inc.

Chief Financial Officer

John Craighead, Ph.D.

IR@elpiscience.com

LifeSci Advisors, LLC

John Fraunces

jfraunces@lifesciadvisors.com

Media inquiries:
Candy Zhao

PR@elpiscience.com