Angiex Announces First Patient Dosed in Phase 1 Clinical Trial of AGX101, a novel TM4SF1-Directed Antibody-Drug Conjugate for the Treatment of Solid Tumors
CAMBRIDGE, Mass. — August 7 2024:
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 tumor, tumor cells and the tumor 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 tumor 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 tumors 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-tumor 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 tumor patient population. The dose expansion portion of the study is designed to evaluate treatment at the Recommended Phase 2 Dose in multiple indications.
AGX101 at ClinicalTrials.gov
The progress of AGX101’s clinical trial can be followed at clinicaltrials.gov via study ID NCT06440005.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “will,” “would,” “predicted,” “potential,” “prospective” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of AGX101 to have first-in-class performance. These statements are based on numerous assumptions concerning the research, beliefs regarding efficacy and mechanisms of actions, therapeutic applications, addressable market and other similar factors, and involve substantial risks, uncertainties and other factors that may cause actual results, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, Angiex disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investor Relations
Mike Zanoni
Endurance Advisors
mzanoni@enduranceadvisors.com