Following $1.2B deal, DualityBio's out-licensed ADC (DB-1418) secures FDA Fast Track designation

On November 11, 2025, Avenzo Therapeutics ("Avenzo"), a U.S.-based clinical-stage biotechnology company developing next-generation oncology therapies, announced that the U.S. FDA has granted Fast Track designation to AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (BsADC). Avenzo is a partner of DualityBio, under an exclusive license agreement established earlier this year.

Under this agreement, Avenzo holds responsibility for the global development, manufacturing, and commercialization of AVZO-1418/DB-1418 (excluding Greater China). DualityBio received an upfront payment of $50 million and is eligible for up to $1.15 billion in development, regulatory, and commercial milestone payments, plus tiered royalties on Avenzo's sales within the licensed territories.

The Fast Track designation was granted for treating patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring an EGFR exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

AVZO-1418/DB-1418 is currently being evaluated in an open-label, Phase 1/2 first-in-human (FIH) clinical trial. The study is designed to assess its safety, tolerability, and preliminary clinical activity both as a monotherapy and in combination therapy for advanced solid tumors.