ABL Bio Receives IND Approval for Phase 1 Clinical Trial of Solid Tumor Anticancer Drug 'ABL103'

ABL Bio, a specialist company in bispecific antibodies, announced on the 9th that it received approval from the Ministry of Food and Drug Safety for the domestic Phase 1 clinical trial plan (IND) of the bispecific antibody immuno-oncology drug 'ABL103'.

Sanghoon Lee, CEO of ABL Bio
[Photo by Chunhee Lee]

This clinical trial will involve dose escalation and tumor expansion studies by administering ABL103 alone to patients with locally advanced or metastatic solid tumors whose disease is progressing. The dose escalation part, planned for 36 patients, will evaluate the safety and tolerability of the drug in about 36 patients in Korea and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The tumor expansion part is expected to be conducted with 60 patients across 6 to 10 institutions, including Korea and the United States. The exact number of patients will be finalized based on the data from the dose escalation part.

ABL103 is a bispecific antibody immuno-oncology drug that simultaneously targets B7-H4 and 4-1BB. It is explained to have a mechanism of action similar to PD-(L)1 antibody immuno-oncology drugs such as 'Keytruda', but shows a negative correlation with PD-(L)1-based therapies in terms of patients and cancer types expressing these targets. Through this, ABL103 is expected to overcome the limitations of PD-(L)1-based immuno-oncology drugs, which are effective in only 20% of all patients, and become a new alternative for patients.

With the IND approval of ABL103, ABL Bio has secured a total of seven clinical pipelines including 'ABL001', 'ABL503', 'ABL111', 'ABL301', 'ABL202', 'ABL105', and 'ABL103'. Sanghoon Lee, CEO of ABL Bio, said, “Through ABL103, our ability to select targets aligned with global trends has been proven,” adding, “More than 15 clinical trials ongoing with different indications and countries will continue to contribute to the increase in ABL Bio’s corporate value.”

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