DualityBio DB-1324 project received clinical trial approval from HREC and TGA in Australia

CAR-T Digest - August 2020

14 October 2025: DualityBio DB-1324 project received clinical trial approval from HREC and TGA in Australia

DualityBio announced that its DB-1324, a next-generation ADC developed using its Duality Immune Toxin Antibody Conjugates (DITAC) platform, has received clinical trial approval from both Australia’s HREC and TGA for the treatment of solid tumors, enabling initiation of a Phase I clinical trial
The DITAC platform is designed to enhance tumor selectivity and immune-mediated cytotoxicity, providing DualityBio with a differentiated approach in ADC development for difficult-to-treat cancers
In 2024, DualityBio entered into an exclusive global licensing agreement with GSK, granting GSK rights (excluding mainland China, Hong Kong, and Macau) to develop and commercialize DB-1324, positioning it as a strategic asset to strengthen GSK’s oncology pipeline
DB-1324 is expected to be explored in combination regimens with other GSK oncology products, reflecting its potential to broaden therapeutic impact across multiple tumor types
Alongside DB-1324, DualityBio is also advancing DB-1314, another ADC candidate in its growing portfolio, underscoring the company’s expanding global clinical footprint and its commitment to developing innovative ADCs for solid tumors