By Fineline Cube 
Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed in its global Phase Ia/Ib clinical trial of the self‑developed ADAM9‑targeting antibody‑drug conjugate (DB‑1317). The study has also secured Investigational New Drug (IND) clearance from the U.S. Food & Drug Administration (FDA), marking a key milestone for the company’s next‑generation ADC platform.
Product Snapshot
- DB‑1317 is built on DualityBio’s proprietary DITAC platform, coupling a high‑affinity ADAM9‑specific antibody to a potent topoisomerase I inhibitor payload.
- Preclinical studies demonstrate robust antitumor activity across multiple gastrointestinal cancer models, including gastric and colorectal malignancies, underscoring its potential for broad clinical translation.
Trial Design
| Feature | Detail |
|---|---|
| Phase | Ia/Ib |
| Enrollment | Advanced solid‑tumor patients (gastric, colorectal, and other solid tumors) |
| Geography | Australia, United States, China (simultaneous enrollment) |
| Primary Endpoints | Safety, tolerability, and preliminary efficacy of DB‑1317 monotherapy |
| Clinical ID | NCT07141706 |
Regulatory & Commercial Implications
- FDA IND clearance removes a major regulatory hurdle, enabling the trial to proceed in the U.S. market and paving the way for potential future approvals.
- DualityBio holds global rights to DB‑1317, positioning the company to negotiate commercial agreements in key oncology markets once safety and efficacy data are available.
- The DITAC platform’s modular design allows for rapid adaptation to other targets, potentially expanding DualityBio’s pipeline beyond gastrointestinal cancers.
Market Context
- The global ADC market is projected to surpass $20 billion by 2030, driven by increasing demand for targeted therapies in oncology.
- ADAM9 is an emerging therapeutic target linked to tumor invasion and metastasis; DB‑1317 represents one of the first ADCs to exploit this pathway.
- DualityBio’s Australian launch aligns with the country’s robust clinical trial ecosystem, offering a strategic foothold for subsequent U.S. and Chinese market entry.
Forward‑Looking Statements
- DualityBio anticipates that Phase Ia/Ib data will inform dosing strategies for the upcoming Phase II expansion.
- The company expects to file a Biologics License Application (BLA) in the U.S. by 2027 should safety and efficacy profiles meet expectations.-Fineline Info & Tech