DB-1419 / DualityBio, Dartsbio Pharmaceuticals - LARVOL DELTA

Repurposing FDA-Approved Drugs as Nav1.7 Channel Modulators: An Integrated Structure-Based Virtual Screening and Molecular Dynamics Study. (PubMed, Int J Mol Sci) - "These findings underscore the value of post-docking MD validation in computational drug discovery and nominate DB01419 and DB15982 as candidate scaffolds that warrant subsequent experimental validation, including electrophysiological characterization and Nav-isoform selectivity profiling. We emphasize that these are computational predictions: in silico binding stability is not equivalent to functional inhibition of Nav1.7 currents, and the lead designations reported here remain hypothesis-generating until confirmed by patch-clamp and biochemical assays."

FDA event • Journal • Pain • NAV1

A phase 1/2a, multicenter, open-label, first in human study of a bispecific ADC targeting B7H3 and PDL1 (DB-1419) in advanced or metastatic solid tumors (AACR 2025) - P1/2 | "As of Dec 05, 2024, four participants have been enrolled in Australia and the United States. Enrollment in China is scheduled to commence in March 2025."

ADC • Bispecific • Clinical • First-in-human • IO biomarker • Metastases • P1/2 data • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • CD276

DB-1419: Augmenting the Translational Potential of Preclinical Findings for Implementation in the Clinic. (PubMed, J Cell Mol Med) - No abstract available

Journal • Preclinical

Preclinical evaluation of DB-1419, a novel bifunctional and bispecific anti-B7-H3×PD-L1 antibody-drug conjugate. (PubMed, Clin Cancer Res) - P1/2 | "DB-1419 demonstrated potent antitumor activity against multiple tumors, with favorable pharmacokinetics and safety profiles. These preclinical data potentially position DB-1419 as a promising treatment approach, currently in the ongoing phase 1/2a study in advanced tumors (NCT06554795)."

IO biomarker • Journal • Preclinical • Liver Cancer • Lung Cancer • Oncology • Solid Tumor • CD276

Yingen Biopharma's new category 1 cancer drug approved for clinical trials in China [Google translation] (bydrug.pharmcube.com) - "The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration is that the Class 1 new drug DB-1419 for injection of Yingen Biotech has been approved for clinical trials and is intended to be developed to treat advanced/metastatic solid tumors."

New trial • Oncology • Solid Tumor

DB-1419, a first-in-class bispecific ADC targeting B7-H3 and PD-L1 with a DNA topoisomerase I inhibitor, exhibits promising efficacy and safety in preclinical models (EORTC-NCI-AACR 2024) - "DB-1419 is a first-in-class bispecific ADC targeting B7-H3 and PD-L1 with a topoisomerase I inhibitor. The simultaneous action of delivering the toxin to tumor cell and modulate T cell activation provides potential synergistic anti-tumor effect. Preclinical studies showed DB-1419 exhibits both direct cancer cell killing and immune modulating function."

IO biomarker • Preclinical • Oncology

First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=360 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Yingen Biopharma’s bispecific ADC clinical application in China has been accepted [Google translation] (bydrug.pharmcube.com) - "On September 11, according to the official website of CDE, the clinical application of Yingen Bio's B7-H3/PD-L1 dual-antibody ADC drug DB-1419 was accepted by CDE. The first human study of DB-1419 (NCT06554795)."

Trial status • Oncology • Solid Tumor

First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=360 | Not yet recruiting | Sponsor: DualityBio Inc.

Metastases • New P1/2 trial • Oncology • Solid Tumor