ABL Bio Partner "Compass" Anticipates Improvement in ABL001 Overall Survival

Lower-Than-Expected Mortality Rate Observed in Phase 2/3 Trial
Positive Impact on Overall Survival Suggests Promise for ABL001 Combination Therapy

ABL Bio, a company specializing in bispecific antibodies, announced on August 13 that its global partner, Compass Therapeutics, has shared a positive update on the clinical development of ABL001 (ingredient name: Tovetumab).

According to Compass Therapeutics, the ongoing randomized Phase 2/3 COMPANION-002 trial evaluating the combination therapy of ABL001 and paclitaxel in patients with advanced biliary tract cancer has reported fewer deaths than initially anticipated. This suggests that ABL001 may have a positive impact on overall survival (OS). Since the analysis of secondary endpoints such as OS and progression-free survival (PFS) can only be conducted once the mortality rate among trial participants reaches 80%, Compass Therapeutics expects the analysis of these endpoints to take place in the first quarter of 2026.

In addition, patient enrollment is progressing smoothly in an investigator-initiated trial (IST) currently underway at the University of Texas MD Anderson Cancer Center. This IST aims to evaluate the potential of ABL001 as a first-line treatment for biliary tract cancer by combining ABL001 with the current standard first-line therapies for biliary tract cancer: gemcitabine, cisplatin, and durvalumab.

Compass Therapeutics is also planning to conduct a Phase 2 basket trial targeting DLL4-positive cancers, including gastric cancer, ovarian cancer, renal cancer, hepatocellular carcinoma, and colorectal cancer. This trial is scheduled to begin after the analysis of secondary endpoints in COMPANION-002.

Lee Sanghoon, CEO of ABL Bio, stated, "ABL001 is a pipeline that has received Fast Track designation from the U.S. Food and Drug Administration (FDA). Based on the clinical data from COMPANION-002, Compass Therapeutics plans to submit a Biologics License Application (BLA) for ABL001 to the FDA in the second half of 2026. We ask for your keen interest in the PFS and OS data for ABL001, which will be released early next year."

ABL001, developed by ABL Bio, is a bispecific antibody that simultaneously blocks the DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A) signaling pathways, both of which play critical roles in angiogenesis and tumor vascular formation. By inhibiting both DLL4 and VEGF-A, ABL001 demonstrates a mechanism of action that suppresses tumor growth, resulting in strong anticancer efficacy. In the Phase 2/3 COMPANION-002 trial of ABL001 combined with paclitaxel in patients with biliary tract cancer, the primary endpoint was achieved, with an objective response rate (ORR) of 17.1%-a statistically significant improvement compared to the 5.3% ORR observed with paclitaxel monotherapy.