DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC

CAR-T Digest - August 2020

25 August 2026: DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC

DualityBio announced that its ADAM9-targeted ADC candidate DB-1317 has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with advanced or metastatic non-small cell lung cancer who have progressed following prior systemic therapy
The designation is supported by clinical data from the ongoing phase 1 study of DB-1317, which is evaluating its safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with advanced solid tumors
The program addresses a significant unmet need in advanced NSCLC, particularly for patients whose disease has progressed after prior systemic treatment and who have limited therapeutic options
DB-1317 is an ADAM9-targeted ADC designed to selectively deliver a topoisomerase I inhibitor payload to ADAM9-expressing tumor cells, with preclinical studies demonstrating antitumor activity across multiple tumor models
Strategically, the FDA Fast Track designation accelerates the regulatory development of DB-1317 in NSCLC, further strengthens DualityBio’s growing ADC pipeline and expands its global development footprint in the increasingly competitive ADAM9-targeted ADC landscape