Angiex Doses First Patient in Phase 1 Trial of AGX101 for Solid Tumors

On August 7, 2024, Angiex, a biotech company specializing in Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid tumors, announced the initiation of a Phase 1 clinical trial for its innovative drug, AGX101. This TM4SF1-targeted antibody-drug conjugate aims to treat solid malignancies.

TM4SF1 is gaining recognition as a promising cancer target due to its unique characteristics: it is expressed both in tumor cells and the tumor vasculature, showing extensive expression in various malignant cancers while being limited in normal tissues. Furthermore, it features a novel internalization pathway that allows the direct delivery of chemotherapeutic agents to the nucleus of cancer cells. Angiex’s co-founder and CEO, Paul Jaminet, highlighted that AGX101 was meticulously designed over 20 years of biological research and 12 years of drug development to leverage TM4SF1’s properties. Preclinical experiments demonstrated AGX101’s ability to combat cancer through multiple mechanisms, showing a wide therapeutic margin in animal models. This gives hope that AGX101 could be significantly beneficial for cancer patients, particularly in cases with high unmet medical needs. Jaminet expressed enthusiasm over the dosing of the first patient in this pioneering human study of AGX101.

Dr. Ildefonso Ismael Rodriguez Rivera from NEXT Oncology, the principal investigator for the study, emphasized the potential of antibody-drug conjugates to enhance the safety and efficacy of chemotherapies by targeting tumors while minimizing the impact on healthy tissues. He described AGX101 as a first-in-class drug with unique mechanisms of action that could address significant medical needs and expressed anticipation for the evaluation of AGX101 in the clinical trial.

The Phase 1 clinical trial is structured as an open-label, dose-escalation, and expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of AGX101 alone. The dose-escalation part of the study will test doses up to 10 mg/kg in patients with various solid tumors. Following this, the dose-expansion phase will assess the recommended Phase 2 dose across multiple indications. Progress of the clinical trial can be monitored on clinicaltrials.gov under the study ID NCT06440005.

Angiex, Inc., headquartered in Cambridge, Massachusetts, is a privately-held biotech startup dedicated to creating drugs with groundbreaking cancer-fighting capabilities by harnessing newly discovered biological transport mechanisms. The company was established by preeminent scientists in angiogenesis, vascular biology, and oncology. Angiex is developing a suite of Nuclear-Delivered Antibody-Drug Conjugates™ (ND-ADCs) designed to release therapeutic agents directly into the nucleus or cytosol of cancer cells, enhancing the efficacy and therapeutic margin beyond that of traditional ADCs. AGX101, their leading product, has successfully progressed through preclinical development and has now entered Phase 1 clinical trials.

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