ABL Bio Completes First Domestic Phase 1 Dosing of Immuno-Oncology Drug 'ABL103'

Evaluation of Safety and Tolerability of ABL103 Monotherapy

ABL Bio announced on the 8th that it has completed the first patient dosing in the domestic Phase 1 clinical trial of its immuno-oncology drug candidate 'ABL103' for patients with advanced and metastatic solid tumors.

ABL Bio CI. [Image provided by ABL Bio]

Through this clinical trial, ABL Bio plans to evaluate the safety and tolerability of ABL103 monotherapy and determine the recommended dose and maximum tolerated dose (MTD) for the upcoming Phase 2 clinical trial.

The Phase 1 clinical trial of ABL103 is being conducted in South Korea and the United States. The dose-escalation part, which observes adverse reactions while increasing the dose, will be conducted at domestic institutions, and subsequently, the tumor expansion part will be conducted simultaneously in South Korea and the United States.

ABL103 is a bispecific antibody targeting both B7-H4 and 4-1BB, and is one of the pipelines applying ABL Bio's 4-1BB-based bispecific antibody platform 'Grabody-T'.

According to ABL Bio, B7-H4 is gaining attention as a new target that can overcome resistance and non-responsiveness, which are limitations of PD-(L)1-based immuno-oncology drugs represented by Keytruda. This is because the B7-H4 antigen is mainly expressed in areas where PD-(L)1 is not expressed.

ABL Bio's ABL103 is designed to enhance therapeutic effects by activating T cells through a 4-1BB antibody bound to a B7-H4 targeting antibody, while also providing long-term tumor relapse prevention through the memory T cell function unique to 4-1BB. Nonclinical studies showed that 4-1BB activation is induced in the tumor microenvironment expressing B7-H4, and the company confirmed complete eradication of cancer cells and suppression of relapse of homologous cancer cells.

Lee Sang-hoon, CEO of ABL Bio, said, "Despite the development of PD-(L)1 therapies, which are considered revolutionary in cancer treatment, there is still a high demand for new next-generation immuno-oncology drugs. ABL103 could be the answer." He added, "With the first patient dosing completed and the Phase 1 clinical trial of ABL103 officially underway, we will do our best to expedite clinical development."

This content was produced with the assistance of AI translation services.