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- Introduction to the clinical design and research methodology of COMPANION-002, a phase 2/3 clinical trial of ABL001 (CTX-009) for certain patients with advanced biliary tract cancer
- A previous phase 2 clinical trial of ABL001 (CTX-009) reported an ORR of 37.5%. Due to the high unmet need for patients with biliary tract cancer, it received Fast Track Designation by the FDA
ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibody today announced that its global partner Compass Therapeutics published a trial in progress paper on ABL001 (CTX-009) in the international journal ‘Future Oncology’. This paper contains information on the research methodology, including study goals, clinical design and primary endpoints of COMPANION-002, a Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen.
ABL001 (CTX-009) is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4) developed by ABL Bio, which induces the death of cancer cells by inhibiting the creation of new blood vessels in cancer tissues. Compass Therapeutics, which holds global rights, is conducting a phase 2/3 clinical trial for patients with biliary tract cancer in the U.S. and Handok, which holds the domestic rights, is participating in the trial in South Korea. In addition to biliary tract cancer, clinical research targeting advanced colorectal cancer is being conducted.
According to the paper, COMPANION-002 is designed to evaluate the efficacy and safety of ABL001 (CTX-009) and paclitaxel combination as a second-line treatment option by comparing this combination regimen to paclitaxel monotherapy. The number of participants is approximately 150, and the primary endpoint is overall response rate (ORR). Secondary endpoints include progression free survival, duration of response, overall survival, disease control rate, safety and quality of life.
ABL001 (CTX-009) and paclitaxel combination therapy showed an ORR of 37.5% (9/24) in patients with advanced biliary tract cancer who had received one or two prior systemic therapies. Among 11 patients treated in the second-line setting, the ORR was 63.6% (n = 7/11) versus 15% (n = 2/13) among patients treated in the third-line setting. The median duration of response was 6.9 months, the median progression free survival was 9.4 months, and the 1-year survival rate was 53 %. Note that FOLFOX, a chemotherapy drug used as a second line treatment option, showed an ORR of 5% and 4 months of median progression free survival .
Biliary tract cancer is a malignant tumor that occurs in the cells of the bile duct, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. In the U.S. alone, approximately 23,000 cases of biliary tract cancer are reported every year, and only 10% of these patients can be diagnosed early and receive surgical treatment. The majority of patients have locally advanced or metastatic biliary tract cancer, and there are few treatment options for them, so their unmet needs are high. ABL001 (CTX-009) and paclitaxel combination therapy received Fast Track Designation by the U.S. Food and Drug Administration (FDA) in April this year for the treatment of patients with metastatic or locally advanced BTC that have been previously treated.
Sang Hoon Lee, CEO of ABL Bio said “our partner Compass Therapeutics is conducting active research and development to obtain approval for ABL001 and paclitaxel combination therapy as a treatment for biliary tract cancer, including the publication in an international academic journal and receiving Fast Track Designation.” And he also said “ABL001 combination therapy is reporting encouraging clinical data, and safety is at a manageable level. We hope that our partners will accelerate the clinical development of ABL001 and help improve the treatment options for patients with biliary tract cancer.”
Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on the bispecific antibody platform ‘Grabody’. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track Designation to support the rapid development of new drugs. Assets such as ABL104 are also preparing to enter clinical trials. In addition, ABL Bio is continuously researching and developing several other non-clinical drugs, including bispecific ADCs.