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

On May 22, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported 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) (Press release, Avenzo Therapeutics, MAY 22, 2025, View Source [SID1234653295]).

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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.

"The clearance of our IND for AVZO-1418 is a significant achievement for Avenzo as this is our second IND in 3 weeks to receive clearance and our first ADC program to advance into the clinic," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-1418 has a differentiated profile with the potential to benefit patients across various solid tumors. We look forward to initiating our Phase 1/2 study later this year and working closely with our partner, Duality Biotherapeutics."

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