# FDA Grants Fast Track Designation to DualityBio HER3 ADC DB-1310 for Advanced Solid Tumors

> fda · REPORTED · 2025-07-22

DualityBio announced on July 22, 2025 that the FDA granted Fast Track designation to DB-1310, its next-generation HER3-targeted antibody-drug conjugate, for advanced solid tumors; Phase 1/2a data presented at ASCO 2025 showed early efficacy signals and a manageable safety profile in heavily pretreated patients. The designation supports accelerated development of DB-1310 as a potential treatment across multiple HER3-expressing tumor types.

About DualityBio: DualityBio is a clinical-stage biopharmaceutical company developing next-generation antibody-drug conjugates including DB-1310, a HER3-targeted ADC engineered with a novel payload and linker for the treatment of advanced solid tumors.

- Company: DualityBio
- Sector: oncology
- Primary source: https://www.curetoday.com/view/july-lung-cancer-highlights-top-5-updates-patients-should-know

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.