ABL Bio said on the 19th that the U.S. Food and Drug Administration (FDA) approved the phase 1 investigational new drug (IND) application for its bispecific Antibody-Drug Conjugate (ADC) candidate ABL206.
An ADC is a therapy that attaches a drug to an antibody to deliver it precisely to cancer cells, and is also called a "guided missile." It consists of an "antibody" that seeks out cancer cells, a drug called a "payload" that kills cancer cells, and a "linker" that connects them.
ABL206 can be likened to a "smart missile" that simultaneously recognizes two cancer targets to deliver a drug. It is a bispecific antibody ADC that targets overexpressed B7-H3 and ROR1 on the surface of cancer cells and is structured by linking a topoisomerase I inhibitor that blocks cancer cell proliferation, aiming to be a first-in-class therapy.
Based on its bispecific antibody technology and experience developing single-antibody ADCs, ABL Bio is pushing ahead with several next-generation ADCs, and ABL206 is the first among them to enter the clinical stage.
Clinical development of ABL206 will be handled by NeocBio, a bispecific ADC company that ABL Bio established in the United States. NeocBio also holds global development and commercialization rights for another bispecific ADC candidate, ABL209.
NeocBio aims to start phase 1 trials for the two candidates in the first half of this year and release early clinical data next year.
Lee Sang-hoon, CEO of ABL Bio, said, "Our first bispecific ADC candidate, ABL206, has entered a phase 1 trial, taking the first step in our journey to develop next-generation ADCs." Mayank Gandhi, CEO of NeocBio, noted, "This IND approval is an important milestone in NeocBio's rise as a clinical-stage bio company and a result that shows the close collaboration between ABL Bio and NeocBio," adding, "We hope to demonstrate the differentiated potential of a new bispecific ADC for patients with solid tumors."