FDA Grants Clearance for Innovative Cancer Treatment AVZO-1418/DB-1418 by Duality Biotherapeutics

FDA Grants Clearance for Innovative Cancer Treatment AVZO-1418/DB-1418

In a significant development for oncology treatment, the U.S. Food and Drug Administration (FDA) has granted clearance for the investigational new drug application (IND) of AVZO-1418/DB-1418, a bispecific antibody-drug conjugate (ADC) developed by Avenzo Therapeutics in partnership with Duality Biotherapeutics. This novel therapeutic candidate aims to target dual receptors—EGFR and HER3—often co-expressed in various solid tumors.

Avenzo, a clinical-stage biotechnology firm that specializes in next-generation oncology therapies, expects to initiate a Phase 1/2 first-in-human clinical study for AVZO-1418/DB-1418 later this year. This trial aims to evaluate both the safety and tolerability of the drug, while also assessing its preliminary clinical activity as a standalone treatment and in combination therapies for patients with advanced solid tumors.

Background and Development

The IND approval follows a strategic licensing agreement announced in January 2025, wherein Avenzo acquired the rights to develop, manufacture, and commercialize AVZO-1418/DB-1418 globally, except in Greater China. This collaboration serves as a testament to the confidence that Duality Biotherapeutics, listed on the Hong Kong Stock Exchange (HKEX:09606), has in Avenzo's capabilities to bring this potential best-in-class therapy to market.

Preclinical studies have already shown promising results, presenting data on AVZO-1418/DB-1418’s groundbreaking design and its unique binding capabilities to EGFR and HER3. The findings, introduced at the American Association for Cancer Research (AACR) Annual Conference in April 2025, highlighted the ADC's efficacy in vivo, demonstrating its effectiveness in treating various tumor types, including those resistant to EGFR tyrosine kinase inhibitors in non-small cell lung cancer (NSCLC) models.

Clinical Implications

The main goal of the upcoming clinical trial is to gather solid evidence on how well AVZO-1418/DB-1418 can perform in real-world patient settings, particularly among those suffering from severe and treatment-resistant cancers. By evaluating the drug both alone and in conjunction with existing therapies, researchers aim to uncover any potential for improved outcomes in patient prognosis. The results from this trial could pave the way for breakthrough treatment options that leverage the latest antibody-drug conjugate technologies.

Duality Biotherapeutics is recognized for its commitment to advancing cancer treatments through innovative ADC platforms. With a diverse and dynamic pipeline, the company is already conducting multiple global clinical trials across 17 countries, engaging over 2,000 patients with various ADC candidates. This extensive network and their existing partnerships with leading biotech firms further position Duality as a frontrunner in the pharmaceutical industry.

The Future Landscape

As the world of oncology is rapidly evolving, the approval of AVZO-1418/DB-1418 signifies a pivotal moment in cancer therapeutic development. Should the clinical studies prove successful, this drug has the potential to become a significant player within the oncology landscape, offering new hope to patients battling advanced cancers that are notoriously challenging to treat. With ongoing support from Duality and the biomedical community at large, the future for AVZO-1418/DB-1418 looks promising. Readers can keep an eye out for trial updates and results emerging from this exciting endeavor.

About Duality Biotherapeutics

Duality Biotherapeutics is a biotech company dedicated to the development of cutting-edge ADCs aimed at treating cancer and autoimmune diseases. Their portfolio leverages advanced technology and extensive intellectual property, reinforcing their commitment to bringing innovative therapies to fruition. For more information about their ongoing projects and partnerships, please visit Duality Biotherapeutics.