ABL Bio Applies for Phase 1 Trial of Bispecific Antibody Immuno-Oncology Drug 'ABL103'

by Lee Myeonghwan

Published 29 Jun.2023 16:58(KST)

ABL Bio announced on the 29th that it has submitted an Investigational New Drug (IND) application for the domestic Phase 1 clinical trial of the bispecific antibody immuno-oncology drug 'ABL103' to the Ministry of Food and Drug Safety.

ABL Bio CI. [Image provided by ABL Bio]

In this clinical trial, ABL103 will be administered as a monotherapy to patients with progressive or metastatic solid tumors. Dose escalation and tumor expansion studies will be conducted. Safety and tolerability of the drug will be evaluated through dose escalation data from approximately 36 patients, and the maximum tolerated dose and recommended Phase 2 dose will be determined. The tumor expansion part is currently planned for 60 patients, with the final number to be confirmed based on data from the dose escalation part.

ABL103, developed by ABL Bio, is a bispecific antibody targeting both B7-H4 and 4-1BB. The company explained that B7-H4 can overcome the limitations of the representative immuno-oncology drug Keytruda. Although Keytruda, a PD-(L)1-based immuno-oncology drug, has indications for more than 20 cancer types, only about 20% of patients show therapeutic effects, highlighting the need for next-generation immuno-oncology drug development to overcome this. B7-H4, the cancer cell target of ABL103, shows a negative correlation with PD-(L)1 expression in major solid tumors, meaning it is mainly expressed where PD-(L)1 is not expressed.

Additionally, ABL Bio explained that ABL103 not only helps activate T cells to enhance therapeutic effects but also has a long-term tumor recurrence prevention effect through memory T cell function. Furthermore, ABL Bio’s bispecific antibody platform technology, Grabody-T, is evaluated as having an optimized structure for 4-1BB activation compared to competitors.

Lee Sang-hoon, CEO of ABL Bio, stated, "In domestic clinical trials, rapid patient recruitment is possible, which can shorten the lengthy dose escalation period, allowing us to keep pace with global companies in development speed." He added, "We consider it meaningful to be able to provide treatment opportunities using the B7-H4x4-1BB bispecific antibody immuno-oncology drug to domestic patients first."