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- Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel in patients with advanced Biliary Tract Cancer
- Approved an Investigator Sponsored Trial of CTX-009 in the first-line setting in patients with Biliary Tract Cancer
ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics has completed planned enrollment of 150 patients in COMPANION-002, a randomized Phase 2/3 clinical trial of CTX-009 (ABL001) in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers.
In addition, along with the completion of enrollment of patients in COMPANION-002, Compass Therapeutics announced the approval of a new Investigator Sponsored Trial (IST) evaluating CTX-009 as a first-line treatment for patients with biliary tract cancer. The clinical trial will be conducted at the MD Anderson Cancer Center at the University of Texas, USA. CTX-009 will be added to gemcitabine, cisplatin, and durvalumab, which is the current standard first-line treatment for biliary tract cancer.
CTX-009, initially developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4) which induces the death of tumor cells by inhibiting the creation of new blood vessels in cancer. Compass Therapeutics, which holds global rights, is currently conducting a phase 2/3 clinical trial for biliary tract cancer patients in the United States based on the phase 2 clinical trial (HDB001A) conducted in Korea by Handok, which holds Korean rights. CTX-009 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in April to support the rapid development of new drugs by developers, and an additional phase 2 clinical trial for patients with colorectal cancer is also underway.
Sang Hoon Lee, CEO of ABL Bio said “Compass Therapeutics has completed patient enrollment in COMPANION-002. We would like to thank the patients and their families who participated in the clinical trial, and all those involved who helped make it run smoothly. In addition, we are very pleased to announce plans to expand the clinical investigation of CTX-009 to first-line treatment with MD Anderson, one of the most prestigious cancer centers in the United States. We will continue to do our best to quickly share news regarding the progress of CTX-009 clinical development.”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, 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 this new drug candidate. 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).
Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.