Duality Biologics, in partnership with BioNTech (NASDAQ: BNTX), has announced the initial data from the global 1/2a phase clinical trial of its B7H3-targeting antibody-drug conjugate (ADC), DB-1311 (BNT324). The trial marks a significant advancement in the treatment of patients with locally advanced or metastatic solid tumors who have previously received multiple lines of therapy. The results were detailed at the 2024 ESMO Asia Congress, highlighting the drug’s potential impact on the treatment landscape for solid tumors.
Encouraging Anti-Tumor Activity and Safety Profile
The data revealed that DB-1311 demonstrated encouraging anti-tumor activity and a manageable safety profile in patients with castration-resistant prostate cancer (CRPC) and other solid tumors. In the CRPC patient group, the unconfirmed objective response rate (uORR) reached 28.0%, with a 6-month imaging progression-free survival rate of 94.7%. These results suggest that DB-1311 could offer a new therapeutic option for patients with CRPC and other advanced solid tumors.
Clinical Trial Design and Patient Enrollment
As of September 27, 2024, the study had enrolled 277 patients with various solid tumors, including small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), CRPC, and head and neck squamous cell carcinoma (HNSCC). Approximately 47% of the patients were from the US and Australia, and 61% had received two or more lines of prior treatment. The primary endpoints of the study are safety and investigator-assessed objective response rate (ORR), with secondary endpoints including duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
DB-1311’s Mechanism and Clinical Significance
DB-1311 is an innovative ADC molecule that targets the B7H3 antigen, which is overexpressed in many solid tumors and associated with disease progression and poor prognosis. The molecule is based on a topoisomerase I inhibitor payload and has shown antitumor activity across various solid tumor models in preclinical studies. The FDA has granted DB-1311 fast track designation for the treatment of advanced or metastatic CRPC and orphan drug designation for the treatment of advanced or metastatic esophageal squamous cell carcinoma, underscoring its potential as a significant therapeutic agent.-Fineline Info & Tech
