Angiex Announces FDA Clearance of IND Application for AGX101, a novel, First-in-Class TM4SF1-Directed Antibody-Drug Conjugate for the Treatment of Solid Cancers

2023-11-02

抗体药物偶联物临床申请临床1期

CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Angiex, a developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid cancers, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. “IND acceptance of AGX101 enables us to initiate our first-in-human study of AGX101 and brings us one step closer to validating AGX101 and demonstrating the value of Angiex’s paradigm-shifting Nuclear-Delivered Antibody-Drug Conjugate™ approach to cancer therapy,” said Marty Duvall, Chief Executive Officer of Angiex. “We are thrilled to advance the development of AGX101 and begin enrolling patients in the Phase 1 study.” “TM4SF1 is an emerging cancer target with exciting features: dual expression on tumor cells and tumor vascular endothelial cells, almost ubiquitous expression across solid tumors, but limited expression in normal tissue, providing for exceptional tumor selectivity,” said Paul Jaminet, Founder, President and Chief Operating Officer of Angiex. “Angiex also is pioneering a novel ability to release ADC payloads in the nucleus of target cells in the tumor. AGX101 is a highly optimized drug based on years of biology research and drug development. Its strong pre-clinical evidence supports its potential to provide transformative outcomes for cancer patients.” 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 AGX-101 monotherapy. The dose escalation portion of the study is designed to assess doses up to 10 mg/kg in an all-comers, solid tumor patient population. The dose expansion portion of the study will evaluate treatment at the Recommended Phase 2 Dose in multiple indications. About Angiex Angiex Inc. is a privately held biotech startup whose mission is to exploit newly discovered biological transport mechanisms to make drugs with revolutionary power over cancer. Based in Cambridge, Mass., Angiex was founded by a scientific team of leading experts in angiogenesis, vascular biology, and oncology. The company is developing a novel portfolio of Nuclear-Delivered Antibody-Drug Conjugates™ (ND-ADCs) that release therapeutic payloads directly into the nucleus or cytosol, where the site of payload action is located. This direct delivery holds the promise of enhancing the efficacy and therapeutic margin of conventional ADCs. The lead product, AGX101, has advanced through pre-clinical development and is about to begin Phase 1 clinical trials. Investor Relations Marty Duvall Angiex, Inc mjduvall@angiex.com Mike Zanoni Endurance Advisors mzanoni@enduranceadvisors.com

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