Friday, November 03, 2023
Angiex, a company specializing in the development of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for the treatment of solid cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for their Investigational New Drug (IND) application for AGX101. AGX101 is a unique antibody-drug conjugate directed at TM4SF1 and is currently in development for the treatment of solid cancers.
Angiex, expressed their excitement about the FDA's acceptance of the IND for AGX101, as it paves the way for the initiation of the first human trial of AGX101. This development brings them closer to validating the efficacy of AGX101 and showcasing the value of Angiex's innovative Nuclear-Delivered Antibody-Drug Conjugate™ approach to cancer therapy. Duvall also mentioned their enthusiasm for advancing AGX101's development and enrolling patients in the Phase 1 study.
Angiex's Founder, President, and COO, highlighted the promising attributes of TM4SF1 as a cancer target. TM4SF1 is known for its dual expression on both tumor cells and tumor vascular endothelial cells, its widespread presence in various solid tumors, and its limited expression in normal tissues, which makes it highly selective for targeting tumors. Angiex is also at the forefront of a novel method for delivering ADC payloads into the nucleus of target cells within the tumor. AGX101, a meticulously optimized drug developed over years of research and drug development, is supported by robust pre-clinical evidence that suggests its potential to offer transformative outcomes for cancer patients.
The Phase 1 study is designed as an open-label, dose-escalation and expansion study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and initial anti-tumor activity of AGX101 when used as a monotherapy. The dose-escalation phase will involve testing various doses, including doses up to 10 mg/kg, in a diverse group of patients with solid tumors. The dose expansion phase will further evaluate the treatment at the Recommended Phase 2 Dose in multiple indications.