FDA Clears AVZO-1418 Investigational New Drug Application by Avenzo Therapeutics

Avenzo Therapeutics, Inc., a biotechnology firm based in San Diego, has announced that the U.S. Food and Drug Administration (FDA) approved its investigational new drug application (IND) for AVZO-1418, which is a promising new treatment for cancer. This drug is a novel bispecific antibody-drug conjugate targeting EGFR/HER3 and is designed to potentially surpass existing therapies.

Following this approval, Avenzo intends to start a Phase 1/2 clinical trial later in the year. This initial phase will focus on evaluating the safety, tolerability, and preliminary clinical effects of AVZO-1418 both as a standalone treatment and in combination with other therapies in patients suffering from advanced solid tumors.

Dr. Mohammad Hirmand, Co-founder and Chief Medical Officer of Avenzo Therapeutics, expressed his enthusiasm for receiving FDA clearance. This marks the company’s second IND approval within three weeks and their first ADC program to progress to clinical trials. Dr. Hirmand emphasized the unique characteristics of AVZO-1418 and its potential benefits for patients across a range of solid tumors. The company is eager to begin the Phase 1/2 study and collaborate closely with Duality Biotherapeutics, their partner in this endeavor.

Preclinical research data on AVZO-1418 was unveiled at the American Association for Cancer Research (AACR) Annual Conference held in April 2025. The findings underscored the innovative design of the drug and its enhanced binding affinity to tumor cells co-expressing EGFR and HER3. Additionally, AVZO-1418 showed effectiveness in xenograft models across various tumor types, including an EGFR TKI-resistant model of non-small cell lung cancer (NSCLC).

Avenzo Therapeutics is a company dedicated to developing advanced oncology treatments. Their primary drug candidate, AVZO-021, is a potent and selective inhibitor of CDK2, crucial in cell cycle regulation. It is currently undergoing a Phase 1 study in the U.S. and Australia for the treatment of advanced solid tumors, as well as in combination therapies for HR+/HER2-negative metastatic breast cancer. Another candidate, AVZO-023, is a selective inhibitor of CDK4, with plans to commence a Phase 1/2 trial in the third quarter of 2025. This study will involve patients with advanced or metastatic HR+/HER2- breast cancer and other advanced solid tumors. Avenzo Therapeutics is headquartered in San Diego, California, dedicated to making strides in cancer treatment innovation.