FDA Approves IND for New EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418

Duality Biotherapeutics and Avenzo Therapeutics have announced that the U.S. Food and Drug Administration (FDA) has cleared their investigational new drug application for a promising new therapy, AVZO-1418/DB-1418. This novel drug is a bispecific antibody-drug conjugate (ADC) targeting EGFR/HER3, which positions it as a potential leader in this class of treatments.

The collaboration between DualityBio and Avenzo was solidified on January 7, 2025, through an exclusive license agreement. This partnership grants Avenzo the rights to develop, produce, and distribute AVZO-1418/DB-1418 worldwide, excluding the Greater China region. The drug's development is part of DualityBio’s strategic efforts to expand its reach in the oncology sector by leveraging advanced ADC technologies.

A key milestone in the drug's development is the planned launch of a Phase 1/2 first-in-human clinical trial later this year. This study will be conducted in an open-label format and will focus on evaluating the safety, tolerability, and initial clinical activity of AVZO-1418/DB-1418. The trial will test the drug both as a standalone treatment and in combination with other therapies in patients suffering from advanced solid tumors.

In April 2025, preclinical findings on AVZO-1418/DB-1418 were shared at the American Association for Cancer Research (AACR) Annual Conference. These findings showcased the innovative design of the drug and its enhanced binding affinity for tumor cells that co-express EGFR and HER3. Additionally, the drug exhibited significant efficacy in various in vivo xenograft models, notably in a model of EGFR TKI-resistant non-small cell lung cancer (NSCLC).

Duality Biotherapeutics is recognized for its commitment to advancing ADCs for cancer and autoimmune diseases. It has developed several state-of-the-art ADC technology platforms, securing global intellectual property rights. The company’s comprehensive pipeline includes multiple clinical trials being conducted in 17 countries, with over 2,000 patients enrolled to test various clinical-stage ADC candidates.

In addition to its innovative research and development activities, DualityBio has formed strategic alliances with multinational corporations and leading biotech companies globally. As a leader in the ADC field, the company focuses on creating bispecific ADCs, novel-payload ADCs, and ADCs targeting autoimmune conditions.

The recent FDA clearance marks a significant step forward for DualityBio and Avenzo, underscoring their shared commitment to developing cutting-edge therapies that address unmet needs in oncology. The planned clinical trials are anticipated to provide vital insights into the potential of AVZO-1418/DB-1418 as a transformative treatment option for patients with challenging cancer types.