Handok is currently conducting a Phase II clinical trial of ABL001 (CTX-009), a next-generation anticancer drug, in Korea, and will expand to clinical trials in the United States in collaboration with Compass Therapeutics.

ABL001 (CTX-009) is a next-generation anticancer drug under development and uses dual antibody platform technology. Handok has signed a license agreement with ABL Bio and has rights in Korea. Its Phase II clinical trial, ongoing since February this year, is on patients with biliary tract cancer.

Handok has signed a strategic cooperation agreement with Compass Therapeutics, a bio-venture based in the U.S., and with whom it is collaborating to develop ABL001 (CTX-009) worldwide (excluding China). Compass Therapeutics holds the worldwide rights to the drug (excluding Korea and China) and submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration in November 2021. Phase II clinical trials are to begin in the U.S during the first quarter of 2022.

The Phase II clinical trial involves co-administering paclitaxel and ABL001 (CTX-009) for patients with biliary tract cancer. The Phase I study is complete and was conducted on patients with unresectable advanced, metastatic, or recurrent biliary tract cancer who had previously received first-line or second-line systemic chemotherapy.

The design of the Phase II clinical trial was derived from the Phase Ib clinical trial, which revealed clinically meaningful results in patients with metastatic biliary tract cancer who had previously been treated with paclitaxel or irinotecan in combination with ABL001 (CTX-009). The Phase I clinical trial of ABL001 (CTX-009) applied Simon’s Two-Stage Design and met the criteria to advance to enter Phase II.