Duality Biologics and BioNTech recently presented positive interim data from a Phase 1-2a clinical trial of BNT324/DB-1311, an investigational antibody-drug conjugate (ADC) targeting B7-H3, at the ESMO Asia Congress 2024. The trial involved 277 participants with various advanced solid tumors, including small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and castration-resistant prostate cancer (CRPC).
BNT324/DB-1311 demonstrated encouraging antitumor activity and a manageable safety profile. The overall unconfirmed objective response rate (uORR) was 32.4% among all evaluable patients, with a disease control rate (DCR) of 82.4%.
The results were particularly promising in SCLC patients. The uORR was 56.2% in this group, with a DCR of 89%. Notably, the uORR reached 70.4% in SCLC patients who had received prior immunotherapy but not topoisomerase 1 inhibitors. In patients with CRPC, the uORR was 28.0%, with a median progression-free survival (rPFS) of 7.2 months.
The most common treatment-related adverse events were manageable and included nausea, decreased neutrophil count, anemia, decreased white blood cell count, decreased appetite, and decreased platelet count.
BNT324/DB-1311 is a next-generation ADC that targets the B7-H3 protein, which is overexpressed in several solid tumors and associated with disease progression and poor prognosis. Preclinical studies have shown BNT324/DB-1311 to be effective in various solid tumor models.
The FDA has granted BNT324/DB-1311 Fast Track designation for the treatment of advanced/unresectable or metastatic CRPC and Orphan Drug Designation for the treatment of advanced or metastatic esophageal squamous cell carcinoma.

Source.