FDA Gives Green Signal To Compass Therapeutics' Mid-Stage Biliary Tract Cancer Trial In US

The FDA has signed off Compass Therapeutics Inc's CMPX IND application for CTX-009 to initiate a global Phase 2 clinical trial for CTX-009 for advanced Biliary Tract Cancers (BTC) in the U.S. and South Korea. 

• The Company plans to include the existing Phase 2 in South Korea in this global study, allowing it to expand the ongoing study of CTX-009 under this IND. 
• CTX-009 is a bispecific antibody that simultaneously targets Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A).
• The Phase 2a trial in South Korea is testing CTX-009 combined with paclitaxel in BTC patients. 
• The Company said that five partial responses have already been observed among the first 17 patients evaluated, leading to a preliminary overall response rate (ORR) of 29%.
• All patients evaluated have had stable disease or better, with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate of 100%. 
• Price Action: CMPX shares are down 1.06% at $2.80 during the market session on the last check Thursday.