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Angiex, a developer of nuclear-delivered antibody-drug conjugate (ND-ADC) therapies for solid cancers, announced that the first patient has been dosed in the phase 1 clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers.
“TM4SF1 is an emerging cancer target with exciting features: expression in two compartments of the tumour, tumour cells and the tumour vasculature; broad expression in malignant cancers, but limited expression in normal tissue; and a novel internalization pathway enabling delivery of chemotherapeutic payloads directly to the nucleus of cells in the tumour environment,” said Paul Jaminet, co-founder and CEO of Angiex. “Building upon 20 years of biological research and through 12 years of drug development, Angiex has tailored AGX101 design to TM4SF1 biology. Preclinical studies have supported AGX101’s ability to attack cancers by multiple mechanisms of action, and demonstrated a broad therapeutic margin in animals. We believe AGX101 has potential to help clinical cancer patients, especially in indications with high unmet need. We are excited to announce that the first patient has been dosed in this first-in-human study of our novel TM4SF1 ADC, AGX101.”
“Antibody drug conjugates are an exciting drug modality that seek to improve the safety and efficacy of chemotherapies by targeting the therapies to tumours and keeping them away from normal tissue,” said Dr. Ildefonso Ismael Rodriguez Rivera, site principal investigator for the study at NEXT Oncology. “AGX101 with its novel and differentiated mechanisms of action represents a first-in-class drug with potential to address high unmet medical needs. We look forward to evaluating AGX101 in this trial.”
The phase 1 study is an open-label, dose-escalation and expansion study designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumour activity of AGX101 monotherapy. The dose escalation portion of the study is designed to assess doses up 10 mg/kg in an all-comers, solid tumour patient population. The dose expansion portion of the study is designed to evaluate treatment at the recommended phase 2 dose in multiple indications.
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