AVZO-1418 / Avenzo Therap, DualityBio - LARVOL DELTA

Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class, Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate (Businesswire) - "Avenzo Therapeutics...announced initiation of a Phase 1/2 clinical study of its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors....The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors."

Trial status • Solid Tumor

Avenzo Therapeutics Announces FDA Clearance of Investigational New Drug Application for AVZO-1418, a Potential Best-in-Class, Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate (Businesswire) - "Avenzo Therapeutics, Inc...announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-1418 (DB-1418), a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC)....Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors."

IND • New P1/2 trial • Solid Tumor

DB-1418, a bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, demonstrates superior and broad antitumor efficacy and favorable safety in preclinical models (AACR 2025) - "Notably, in an osimertinib-resistant NSCLC xenograft model with the C797S mutation, DB-1418 induced tumor regression with a TGI of 98% at a dose of 6 mg/kg Q3W, significantly higher than the BL-B01D1 analog at 6 mg/kg Q3W (TGI of 68%, p<0.01). DB-1418 has shown promising pharmacological and pharmacokinetic properties, differentiated from the current clinical trial bispecific ADC targeting EGFR and HER3, with a broader therapeutic window. DB-1418 offers additional treatment options for patients who have developed resistance to EGFR tyrosine kinase inhibitors (TKIs) and addresses other unmet medical needs."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • EGFR • ERBB3

Avenzo Therapeutics and DualityBio Announce Exclusive Global License for Potential Best-In-Class EGFR/HER3 Antibody-Drug Conjugate (Businesswire) - "Avenzo Therapeutics, Inc...and Duality Biotherapeutics...today announced that they have entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China)...Under the terms of the agreement, DualityBio will receive an upfront payment of $50 million and will be eligible to receive up to approximately $1.15 billion in development, regulatory and commercial milestone payments. In addition, DualityBio is eligible to receive tiered royalties on sales in Avenzo’s territory....IND-enabling studies are ongoing with plans to advance AVZO-1418/DB-1418 into a first-in-human clinical study this year."

Licensing / partnership • New trial • Solid Tumor