DualityBio recently announced that its bispecific ADC drug DB-1419, developed based on its proprietary DIBAC platform, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) and a Clinical Trial Notification (CTN) from Australia's Therapeutic Goods Administration (TGA). The drug is intended for the treatment of patients with advanced or metastatic solid tumors and has successfully completed the first global patient dosing (NCT06554795). 

 DB-1419 is a potential first-in-class B7-H3/PD-L1 bispecific ADC, composed of a humanized B7-H3/PD-L1 bispecific antibody covalently linked to a topoisomerase inhibitor via a cleavable linker. It combines the pan-cancer expression of B7-H3 with the immune-modulating function of PD-L1, enabling synergistic anti-tumor effects across a broad range of tumor cells. Preclinical studies have demonstrated that DB-1419 can effectively kill cancer cells and activate T-cells. In immune-reconstituted models, DB-1419 exhibited stronger tumor growth inhibition compared to monospecific B7-H3 ADCs.

Dr. Zhongyuan Zhu, CEO and Founder of DualityBio, stated: "DB-1419 effectively combines the tumor cell-killing effects mediated by the ADC payload with the immune therapeutic activity mediated by the antibody, offering an innovative approach to cancer treatment. The FDA's IND approval and the completion of the first global patient dosing mark another milestone in DualityBio's clinical development. DB-1419 is the sixth ADC innovative drug from DualityBio to enter clinical research, reflecting our mission to 'become a global leader in ADC innovation and serve patients worldwide.'"