Handok ABL001 converted to multi-country phase 2 clinical trials for biliary tract cancer patients

Handok’s anticancer drug candidate, ‘ABL001(CTX-009)’, applied with dual antibody platform technology, is speeding up global clinical trials.

This is in accordance with the Ministry of Food and Drug Safety’s approval of the clinical trial plan change on the 26th to expand the phase 2 clinical trial for BL001 to multiple countries.

Regarding the clinical trial plan change, Handok Chairman Kim Young-jin said, “ABL001 (CTX-009) is showing significant partial remission and tumor reduction data in Handok’s ongoing clinical trial for patients with biliary tract cancer.” “We will do our best to make this drug a new treatment alternative for the currently limited treatment of biliary tract cancer.”

According to the company, ABL001 is a next-generation anticancer treatment that is being developed using dual antibody platform technology. Handok has signed a license agreement with ABL Bio and has the rights in Korea.

The design of the ABL001 phase 2 clinical trial for patients with biliary tract cancer was derived from the phase 1b clinical trial that showed clinically meaningful results in patients with metastatic biliary tract cancer. Phase 2 clinical trial is a method of co-administration of paclitaxel and ABL001 for patients with biliary tract cancer. It is intended for patients with unresectable, advanced, metastatic, or recurrent biliary tract cancer who have previously received first-line or second-line systemic chemotherapy.

A company official said, “Through the ongoing domestic clinical trials, we have laid the foundation for ABL001’s development into global clinical trials and have been able to secure global data.” Based on the design and results, the US FDA approved the IND for ABL001 phase 2 clinical trial in January this year.”

He continued, “The clinical data of ABL001 recently announced by Compass Therapeutics is also based on the first phase of phase 2 clinical trials in Korea. We plan to proceed,” he added.

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