Shanghai/Suzhou, China, October 15, 2021. Elpiscience Biopharma, a global clinical-stage biotech company focusing on the discovery and development of next-generation cancer immunotherapies, today announced that Center of Drug Evaluation (CDE) has cleared Elpiscience’s IND application for ES104 to initiate a Phase I clinical trial in China.
ES104 is a bispecific antibody, targeting DLL4 and VEGF simultaneously. Based on the first in-human Phase 1 single agent dose escalation and expansion study in Korea, ES104 hasdemonstrated significant clinical activity as a stand-alone therapy. According to the data, among patients with advanced solid tumors with a median of three prior lines of systemic anticancer therapies (>60% of patients were previously treated with anti-VEGF antibodies containing regimens), the confirmed overall response rate (ORR) across all dose levels tested (0.3 – 17.5mg/kg) was 8%, and the clinical benefit rate (CBR) was 62%. The ORR at the Recommended Phase 2 Dose (RP2D) was 19%, and the CBR at the RP2D was 69%. Importantly, the response rate is almost three times that seen for current 3rd and 4th line therapies in patients with colorectal and gastric cancers. Meanwhile, ES104 was well tolerated across all doses evaluated, with no dose-limiting toxicities reported.
Dr. Steve Chin, M.D., CMO of Elpiscience, said “We are very pleased that CDE has cleared the China IND Application for ES104, overseas clinical data has demonstrated a preliminary testament to its potential to benefit heavily pr-treated patients with advanced solid tumors. We will move forward with this clinical program with an all-out effort, and we are eager to explore its therapeutic prospect in treatment for digestive tract cancer with a high incidence rate in China to fulfill a significant unmet medical need. Hopefully, the product will provide more feasible therapeutic intervention for benefit cancer patients”.
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 shows that blockade of 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. Phase 1b and Phase 2 combination studies are ongoing. Greater China Rights of ES104 were held by 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”. The company has four assets in the clinical stage (ES101, ES102, ES104 and ES002). 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 potentially innovative or differentiated global molecule into the clinic each year, providing clinical benefits to cancer patients worldwide.