Abl Bio announced on March 3rd that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its dual-antibody antibody-drug conjugate (ADC) candidate, ‘ABL209 (NEOK002)’. The approval was granted on the 27th of last month, local time.
ABL209 represents a sophisticated shift in oncology, combining a topoisomerase I inhibitor with dual antibodies that simultaneously target the epidermal growth factor receptor (EGFR) and mucin 1 (MUC1). While EGFR is known to drive cancer cell proliferation, MUC1 is a glycoprotein frequently overexpressed on the surface of malignant cells. By maintaining DNA in a cleaved state during replication, the topoisomerase I inhibitor induces lethal damage, leading to the death of the cancer cell.
Unlike existing treatments that target only one of these markers, ABL209 is engineered to bind to both EGFR and MUC1. This dual-targeting approach is designed to enhance efficacy and overcome the resistance mechanisms that often limit the success of single-target therapies.
The development of ABL209—along with another solid tumor treatment, ‘ABL206 (NEOK001)’, which recently received its own FDA approval—is being managed by Neok Bio, Abl Bio’s U.S.-based subsidiary. Neok Bio anticipates releasing the initial clinical data for both candidates in 2027.
“With the FDA’s approval of the IND for ABL209 following ABL206, the development of our next-generation ADCs has officially begun,” stated Lee Sang-hoon, CEO of Abl Bio. “Neok Bio has finalized clinical preparations with a team of experts possessing extensive experience in ADC development.”
Mayank Gandhi, CEO of Neok Bio, added, “Dual-antibody ADCs will provide a new solution capable of expanding the limited therapeutic range currently seen with existing single-antibody ADCs.”
