Angiex submits IND to FDA for AGX101

19 September 2022

Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC) therapies for solid cancers, announces the submission of an Investigational New Drug (IND) application on its lead product, AGX101, to the FDA. 

CAMBRIDGE, Mass. — September 19, 2022:

Pending feedback from the agency, Angiex looks to begin enrolling the first patients in the clinical trial in Q4 of this year. The Phase 1 trial will focus on solid cancer patients with late stage disease who have few or no therapeutic options.

AGX101 is a humanized TM4SF1-directed antibody and microtubule inhibitor antibody drug conjugate (ADC) being developed as an intravenously (IV) administered therapeutic. The TM4SF1-directed antibody is linked to a tubulin-inhibiting maytansine payload via a noncleavable covalent linker and site-specific conjugation to an engineered cysteine.

TM4SF1 is a novel ADC antigen that is highly expressed in tumor cells and tumor associated vascular endothelium, and is differentiated by its internalization to the nucleus. AGX101 has been shown to be highly potent both in vitro and in vivo, and has achieved complete tumor regressions in multiple human tumor xenograft models in mice. AGX101 is the first in Angiex’s pipeline of Nuclear Delivery Antibody-Drug ConjugatesTM, and proof of concept for Angiex’s Nuclear Delivery PlatformTM.

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. To learn more about Angiex...