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- 17.1% ORR, the primary endpoint, confirmed by independent central radiology review
- Full clinical results, including OS, PFS, and full safety data are expected to be announced later this year
Pangyo (South Korea) – April 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics presented the top-line data from the Phase 2/3 clinical trial of ABL001/tovecimig (CTX-009/HDB001A), COMPANION-002, in patients with advanced biliary tract cancer.
Tovecimig (ABL001), originally developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4). It inhibits angiogenesis within tumor tissues, thereby inducing cancer cell death. Compass Therapeutics, which holds global rights, took over the Phase 2 clinical trial conducted in South Korea by Handok, which holds the Korean rights, and is currently conducting the Phase 2/3 clinical trial (COMPANION-002) in the United States.
COMPANION-002 is a clinical trial designed to evaluate the potential of tovecimig (ABL001) as a second-line treatment for patients with biliary tract cancer. The study aims to compare the safety and efficacy of the combination therapy of tovecimig (ABL001) and paclitaxel with paclitaxel monotherapy. The primary endpoint of COMPANION-002 is the objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response (DoR).
According to the top-line data from the Phase 2/3 clinical trial announced by Compass Therapeutics, the ORR of the combination therapy of tovecimig (ABL001) and paclitaxel was 17.1%, compared to a 5.3% ORR for the paclitaxel monotherapy arm, and this difference was statistically significant (p=0.031). Notably, the ORR for the combination therapy of tovecimig (ABL001) and paclitaxel was also higher than the ORR of 4.9% observed in a separate study for FOLFOX, another treatment regimen that is used in the second line setting for biliary tract cancer. The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig (ABL001) in combination with paclitaxel versus 42.1% in patients on paclitaxel alone. Compass Therapeutics plans to announce the full clinical results of COMPANION-002, including secondary endpoints such as PFS, OS and DoR, by the end of this year.
Sang Hoon Lee, CEO of ABL Bio said, “We are very pleased that ABL001 has shown promising results in the Phase 2/3 clinical trial for patients with biliary tract cancer. The true incidence of biliary tract cancer is underappreciated; most patients suffer from advanced or metastatic forms that are not amenable to surgical treatment, leaving them with limited therapeutic options. Considering the high unmet medical need, ABL001 received Fast Track designation from the U.S. Food and Drug Administration (FDA) last year. We hope that the positive clinical data will enable a path to approval and commercialization."
As background, biliary tract cancer is a malignant tumor that occurs in the cells of the bile ducts, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. Compass Therapeutics estimates that approximately 23,000 patients are diagnosed with biliary tract cancer annually in the United States, with the second-line treatment market size expected to exceed $1 billion. In addition to COMPANION-002, Compass Therapeutics is also supporting an Investigator Sponsored Trial (IST) to evaluate ABL001 as a first-line treatment for biliary tract cancer. This trial is being led by MD Anderson Cancer Center at the University of Texas and is investigating the addition of tovecimig (ABL001) to the standard treatment regimen of gemcitabine, cisplatin, and durvalumab.
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).