On September 2, 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-103 (formerly VAC-103), a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC) (Press release, Avenzo Therapeutics, SEP 2, 2025, View Source [SID1234655635]). Avenzo has also exercised its exclusive option for AVZO-103 from VelaVigo, securing global (excluding Greater China) development, manufacturing, and commercialization rights.

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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-103 as a single agent and in combination therapy in patients with advanced solid tumors.

"The clearance of our IND for AVZO-103 marks our third IND clearance this year, highlighting the productivity and dedication of our R&D team," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This bispecific ADC is designed to simultaneously target Nectin4 and TROP2 to potentially enhance tumor cell killing while sparing normal tissue. We look forward to studying its potential to address significant unmet needs for patients with cancers that co-express these targets, including urothelial cancer."