[Asia Economy Reporter Lee Chun-hee] Handok is expanding the Phase 2 clinical trial of 'ABL001(CTX-009)', a next-generation anticancer drug under development, into a global clinical trial.
On the 30th, Handok announced that on the 26th, it received approval from the Korea Ministry of Food and Drug Safety for a clinical trial protocol amendment to expand the Phase 2 clinical trial of ABL001(CTX-009) into a multinational clinical trial.
ABL001(CTX-009) is a next-generation anticancer drug developed using bispecific antibody platform technology. Handok holds domestic rights through a licensing agreement with ABL Bio and has been leading the domestic Phase 2 clinical trial focused on cholangiocarcinoma since February last year.
Additionally, in January, Compass Therapeutics, a U.S. bio-venture affiliated with Handok, received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial plan of ABL001(CTX-009) based on the domestic clinical design and results. Going forward, the two companies plan to collaborate on the Phase 2 clinical trial in the U.S. using the same protocol as the domestic trial.
The current Phase 2 clinical trial of ABL001(CTX-009) targeting cholangiocarcinoma patients is being conducted by administering a combination of paclitaxel and ABL001(CTX-009). It is conducted on patients with unresectable advanced, metastatic, or recurrent cholangiocarcinoma who have previously received first- or second-line systemic chemotherapy.
Kim Young-jin, Chairman of Handok, stated, “ABL001(CTX-009) is showing meaningful partial responses and tumor reduction data in the clinical trial targeting cholangiocarcinoma patients conducted by Handok,” and added, “With the global clinical trial now underway, we will do our best to make ABL001(CTX-009) a new treatment option in the currently limited cholangiocarcinoma treatment landscape.”
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