DualityBio announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its next-generation HER3-targeting antibody-drug conjugate DB-1310 for treating adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer. The designation specifically applies to patients with EGFR exon 19 deletion or L858R mutation who have experienced disease progression following treatment with a third-generation EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
Clinical Development Milestone
The Fast Track Designation is intended to expedite the development and review of drugs that treat serious conditions and address unmet medical needs. This regulatory milestone positions DB-1310 to potentially provide a new treatment option for patients with limited therapeutic alternatives in this specific patient population.
DB-1310 represents a novel ADC targeting HER3 developed using DualityBio's proprietary DITAC platform. The company has been conducting global clinical trials across 17 countries and has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.
Promising Clinical Data
In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles presented first-in-human Phase I/IIa clinical trial data for DB-1310 at the American Society of Clinical Oncology Annual Meeting. The results from the NCT05785741 study demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.
Dr. Hua Mu, Global Chief Medical Officer of DualityBio, emphasized the clinical potential of DB-1310: "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity."
Strategic Development Focus
DualityBio is positioning itself as a global ADC powerhouse, developing bispecific ADCs, novel-payload ADCs, and autoimmune ADCs. The company has established strategic collaborations with global multinational corporations and leading biotech innovators to advance its robust pipeline.
The company plans to accelerate the clinical development of DB-1310, with the goal of establishing it as a next-generation HER3 ADC therapeutic option for a broad population of cancer patients. The Fast Track Designation could enhance DualityBio's position in the competitive ADC market and potentially expedite the path to regulatory approval for this targeted therapy.
