Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has unveiled the first batch of results from the global Phase I/IIa clinical study for its investigational next-generation antibody-drug conjugate (ADC), BNT324/DB-1311, targeting the transmembrane glycoprotein B7-H3. The data, presented during an oral session at the 2024 ESMO Asia Congress, demonstrated promising antitumor activity across various cancer types.
Overall and Specific Cancer Type Response Rates
Among all evaluable patients with at least one post-baseline tumor assessment (n=238), the overall unconfirmed overall response rate (uORR) was 32.4%, and the disease control rate (DCR) was 82.4%. In specific cancer types, patients with small cell lung cancer (SCLC, n=73) showed a uORR of 56.2% and a DCR of 89.0%. For non-small cell lung cancer (NSCLC), non-squamous histology patients (n=41) had a uORR of 22.0%, while those with squamous NSCLC (n=25) had a uORR of 16.0%. Castration-resistant prostate cancer (CRPC) patients (n=32) exhibited an uORR of 28.0% and a DCR of 92.0%. Other tumor types, including cervical cancer, hepatocellular carcinoma, head and neck squamous carcinoma, and melanoma, also showed significant antitumor activity with uORRs ranging from 25.0% to 100.0%.
BNT324/DB-1311’s Mechanism and Regulatory Designations
BNT324/DB-1311 is a next-generation topoisomerase-I-inhibitor-based ADC candidate developed through a global strategic partnership between BioNTech and DualityBio, targeting the immune checkpoint protein B7-H3. The drug has received Fast Track designation and Orphan Drug Designation in the US for the treatment of advanced/unresectable, or metastatic CRPC and advanced or metastatic esophageal squamous cell carcinoma, respectively, in June and July 2024.-Fineline Info & Tech
