By Fineline Cube 
Duality Biotherapeutics, Inc. (DualityBio, HKG: 9606) announced that its co‑developed EGFR/HER3 bispecific antibody‑drug conjugate (ADC), AVZO‑1418/DB‑1418, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for a high‑unmet‑need subset of non‑small cell lung cancer (NSCLC).
Deal & Development Overview
| Item | Detail |
|---|---|
| Company | Duality Biotherapeutics, Inc. (DualityBio, HKG: 9606) |
| Partner | Avenzo Therapeutics, Inc. (Avenzo) – exclusive global license (ex‑Greater China) |
| Product | AVZO‑1418/DB‑1418 – EGFR/HER3 bispecific ADC (potential best‑in‑class) |
| Regulatory Milestone | FDA Fast‑Track Designation (FTD) |
| Indication | Unresectable locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation, progressed after EGFR‑TKI therapy |
| Trial Phase | Open‑label Phase 1/2 first‑in‑human (FIH) ongoing |
| License Agreement | Signed Jan 2025 – Avenzo responsible for development, manufacturing, and worldwide commercialization (excluding Greater China) |
| Next Milestones | Completion of Phase 1/2 dose‑escalation (mid‑2026); submission of IND‑enabling data to FDA (late 2026) |
Clinical Rationale & Early Data
- Bispecific Targeting: Simultaneous binding to EGFR (driving oncogenic signaling) and HER3 (mediating resistance pathways) aims to overcome the common escape mechanisms seen after EGFR‑TKI treatment.
- ADC Payload: Potent cytotoxic warhead linked via a cleavable linker designed for selective release within tumor cells, enhancing the therapeutic index.
- Pre‑clinical Highlights: In EGFR‑mutant xenograft models, AVZO‑1418 achieved >90 % tumor regression with minimal off‑target toxicity, outperforming monotherapy ADCs and third‑generation TKIs.
Market Impact & Financial Outlook
- Unmet Need: Approximately 15 % of NSCLC patients harbor EGFR exon 19 deletion or L858R mutations and progress after first‑line TKIs, representing a $2.5 bn addressable market in the U.S. alone.
- Revenue Projection: DualityBio estimates US$120 million–US$180 million in 2028 sales (post‑approval) assuming 5–7 % market share of the EGFR‑mutant NSCLC segment.
- Strategic Fit: The Fast‑Track status accelerates regulatory review, potentially shortening time‑to‑market by 12–18 months versus standard pathways.
- Partnership Leverage: Avenzo’s global commercial infrastructure and manufacturing capacity position the duo to launch AVZO‑1418 simultaneously in North America, Europe, and select Asian markets.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, clinical outcomes, and commercial expectations for AVZO‑1418/DB‑1418. Actual results may differ due to risks including clinical trial performance, regulatory approvals, competitive dynamics, and manufacturing scale‑up.-Fineline Info & Tech