FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418

Phase 1/2 first-in-human clinical study planned this year

, /PRNewswire/ -- Duality Biotherapeutics ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, today 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).

On January 7th, 2025, DualityBio and Avenzo announced that they 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 IND, a Phase 1/2 first-in-human, open-label clinical study is planned to initiate later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-1418/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

Preclinical data for AVZO-1418/DB-1418 were presented for the first time at the American Association for Cancer Research (AACR) Annual Conference in April 2025 and highlighted AVZO-1418/DB-1418's novel design and additive binding affinity in EGFR and HER3 co-expressing tumor cells. In addition, AVZO-1418/DB-1418 demonstrated efficacy in in vivo xenograft models across multiple tumor types, including in an EGFR TKI-resistant NSCLC model.

About DualityBio

Duality Biotherapeutics (HKEX:09606) is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADCs to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries and has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.

Additionally, DualityBio has established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs, including bispecific ADC candidates, novel-payload ADC candidates, and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com.

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