Compass Therapeutics, a U.S. company in collaboration with Handok, received approval on January 18, 2022 (local time) for its Phase II clinical trial plans (Investigational New Drug Application: IND) for ABL001 (CTX-009), a next-generation anticancer treatment, from the U.S. Food and Drug Administration.

This approval is significant in that Handok’s Phase II clinical trial of ABL001 (CTX-009) for biliary tract cancer treatment is expanding to the United States and becoming a global clinical trial. Data from Handok’s domestic Phase IIa clinical trial made approval of the Phase IIb clinical trial a smooth process. The two companies will cooperate and proceed with Phase IIb in the U.S. based on an identical protocol to the one used for the clinical trial in Korea led by Handok.

Handok has signed a strategic cooperation agreement with U.S. bio-venture Compass Therapeutics to develop ABL001 (CTX-009) worldwide (excluding China). ABL001 (CTX-009) is a next-generation anticancer treatment developed by ABL Bio using dual antibody platform technology. Handok and Compass Therapeutics each signed a license agreement with ABL Bio, so Handok holds the rights in Korea for ABL001 (CTX-009), while Compass Therapeutics holds the rights worldwide, excluding Korea and China.

Handok not only cooperates in joint development with Compass Therapeutics, but also holds a stake in the company. Compass Therapeutics has a clinical-stage pipeline and focuses on the development of proprietary antibody therapeutics for cancer treatment. In November of last year, it received an investment of USD 125 million and was listed on the NASDAQ. It has a USD 277 million market cap today.

The Phase II clinical trial is in progress and involves concomitantly administering paclitaxel and ABL001 (CTX-009) to patients with biliary tract cancer. This study is conducted in patients with unresectable advanced, metastatic or recurrent biliary tract cancer who have also previously received first-line or second-line systemic chemotherapy. Handok completed the registration of patients in the Phase IIa clinical trial, and is planning to proceed to the next stage with the addition of Compass Therapeutics and a clinical institution in the United States.