Handok received approval from the Korean Ministry of Food and Drug Safety for its revised clinical trial plan for the multinational expansion of Phase 2 clinical trials of the next-generation anticancer drug ABL001 (CTX-009) on May 26, 2022. The approval will facilitate Handok’s global clinical trials of ABL001 (CTX-009).

ABL001 (CTX-009) is a next-generation anticancer drug under development using bispecific antibody platform technology. Handok has signed a license agreement with ABL Bio and holds the rights in Korea. Having focused on biliary tract cancer, it has been leading the Phase 2 clinical trial of ABL001 (CTX-009) in Korea since February 2021.

Through ongoing clinical trials in Korea, Handok will be able to lay the groundwork for ABL001 (CTX-009) to develop into a global clinical trial and secure global data. Compass Therapeutics, a US bio-venture affiliate of Handok, received approval for its submission of Investigational New Drug (IND) for Phase 2 clinical trial for ABL001 (CTX-009) from the US Food and Drug Administration (FDA) in January 2022 based on its Korean clinical design and results. The clinical data of ABL001 (CTX-009) recently announced by Compass Therapeutics is also based on the first Phase 2 clinical trial in Korea. In the future, the two companies will cooperate in conducting Phase 2 clinical trials in the US using the same protocol as the Handok-led Korean clinical trial.

The design of the Phase 2 clinical trial of ABL001 (CTX-009) for people with biliary tract cancer was derived from the Phase 1b clinical trial, which showed clinically significant results in people with metastatic biliary tract cancer. The Phase 2 clinical trial of ABL001 (CTX-009) is a co-administration of paclitaxel and ABL001 (CTX-009) to people with biliary tract cancer. It was conducted on those with unresectable, advanced, metastatic or recurrent cholangiocarcinoma who had previously received first- or second-line systemic chemotherapy.