SHANGHAI and SAN DIEGO, May 22, 2025 — Duality Biotherapeutics (“DualityBio”, HKEX:09606) and its partner Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotech company focusing on next-generation cancer treatments, announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for AVZO-1418/DB-1418. This drug is a novel EGFR/HER3 bispecific antibody-drug conjugate (ADC) with potential to become a best-in-class therapy.
On January 7, 2025, DualityBio and Avenzo signed an exclusive license agreement. Under this deal, Avenzo will develop, manufacture, and commercialize AVZO-1418/DB-1418 worldwide, except in Greater China.
A Phase 1/2 first-in-human clinical trial is planned to begin later this year. This open-label study will evaluate the safety, tolerability, and early clinical effects of AVZO-1418/DB-1418 alone and in combination with other therapies in patients with advanced solid tumors.
Preclinical results were presented at the American Association for Cancer Research (AACR) Annual Conference in April 2025. The data showed AVZO-1418/DB-1418’s unique design and strong binding to tumor cells expressing both EGFR and HER3. The drug also proved effective in animal models of various cancers, including a model of non-small cell lung cancer (NSCLC) resistant to EGFR tyrosine kinase inhibitors.
About Duality Biotherapeutics
DualityBio is a clinical-stage biotech company listed on the Hong Kong Stock Exchange (HKEX:09606). It focuses on discovering and developing advanced ADCs to treat cancer and autoimmune diseases. The company owns several innovative ADC technology platforms protected by global patents. DualityBio currently runs multiple clinical trials in 17 countries and has enrolled over 2,000 patients across its pipeline of ADC drug candidates.
The company also partners with global multinational corporations and leading biotech innovators. As a key player in the ADC field, DualityBio is advancing new bispecific ADCs, novel payload ADCs, and autoimmune ADC candidates.
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