AVZO-1418 / Avenzo Therap, DualityBio - LARVOL DELTA

Avenzo Therapeutics Granted Fast Track Designation for AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with EGFR-Mutated TKI-Pretreated NSCLC (Businesswire) - "The designation was granted for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR tyrosine kinase inhibitor (TKI)....AVZO-1418 is currently being studied in a Phase 1/2 first-in-human, open-label clinical study 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."

Fast track • Non Small Cell Lung Cancer

A phase 1/2 study of AVZO-1418, a bispecific antibody-drug conjugate (ADC), as a single agent and in combination therapy in patients with locally advanced or metastatic solid tumors (AACR-NCI-EORTC 2025) - P1/2 | "In xenograft models, AVZO-1418 showed significant anti-tumor activity across various tumor types, including an osimertinib-resistant NSCLC model (NCI-975 engineered with EGFR C797S mutation), and can be a potentially effective treatment option for solid tumors co-expressing or mono-expressing EGFR and/or HER3. The trial is actively recruiting and plans to enroll patients at ~50 centers across North America, Europe, and APAC. Clinical trial identification [NCT07038343]; AVZO-1418-1001 [June 6, 2025]."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P1/2 data • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ERBB3 • HER-2

Avenzo Therapeutics Announces $60 Million Series B Financing (Businesswire) - "The proceeds will be used to support the advancement of Avenzo’s pipeline of potential best-in-class oncology drug candidates."

Financing • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

Avenzo Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate (Businesswire) - "Avenzo Therapeutics...announced that the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating 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

Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001) (clinicaltrials.gov) - P1/2 | N=430 | Recruiting | Sponsor: Avenzo Therapeutics, Inc.

New P1/2 trial • Lung Cancer • Oncology • Solid Tumor

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