Compass Therapeutics Completes Patient Enrollment in COMPANION-002, a Randomized Study of CTX-009 in Combination with Paclitaxel, and Provides an Update on the Development Plan in Biliary Tract Cancer

Core Insights - Compass Therapeutics has completed enrollment of 150 patients in the COMPANION-002 trial, a Phase 2/3 study evaluating CTX-009 in patients with unresectable advanced metastatic or recurrent biliary tract cancers [1][4] - The company has received approval for an Investigator Sponsored Trial (IST) to study CTX-009 in the first-line setting for biliary tract cancer, which will be conducted at The University of Texas MD Anderson Cancer Center [3] Group 1: COMPANION-002 Trial - The COMPANION-002 study is a multi-center, open-label, randomized trial comparing CTX-009 plus paclitaxel to paclitaxel alone in patients who have received one prior systemic chemotherapy regimen [4] - The primary endpoint of the trial is the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of response (DOR) [4] - The trial is being conducted at 33 clinical sites across the United States [4] Group 2: CTX-009 Overview - CTX-009 is a bispecific antibody that blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are essential for angiogenesis and tumor vascularization [5] - Preclinical and early clinical data suggest that CTX-009 provides robust anti-tumor activity across various solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer [5] - Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients resistant to approved anti-VEGF therapies [5] Group 3: Company Background - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on developing antibody-based therapeutics for multiple diseases, particularly in oncology [6] - The company's scientific focus includes the relationship between angiogenesis, the immune system, and tumor growth, with a pipeline targeting critical biological pathways for effective anti-tumor responses [6] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass aims to advance its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [6]