ABL Bio gets OK for phase 1 clinical trials for immune-oncology drug

New drug development company ABL Bio Inc. announced on Thursday that it has received approval from the Ministry of Food and Drug Safety of South Korea for the domestic phase 1 clinical trial plan of the bispecific antibody immune-oncology drug ABL103.

As a result, the company will proceed with the dose escalation and tumor expansion trials of ABL103, focusing on patients with advanced or metastatic solid tumors.

In the dose escalation part, the safety and tolerability of the drug will be evaluated using data from around 36 patients, determining the maximum tolerated dose and the recommended phase 2 dose. The tumor expansion part is planned to involve approximately 60 patients.

ABL103, which simultaneously targets the B7-H4 antigen present in tumors and the 4-1BB antigen that activates immune cells, exhibits a mechanism of action similar to existing immune-oncology drugs based on pembrolizumab, as represented by Keytruda. However, the company explained that ABL103 shows differences in both treatable patients and cancer types.

With the approval of the latest clinical plan, ABL Bio now holds a total of seven clinical pipelines and is conducting more than 15 clinical trials in countries including the United States, China, Australia and Korea.

"The approval of ABL103 demonstrates our ability to select targets that align with global trends. The ongoing clinical trials in over 15 different indications and countries will continue to contribute to the rise of our company's corporate value," said Lee Sang-hoon, CEO of ABL Bio.

Write to Yoo-Rim Kim at youforest@hankyung.com