AGX101 / Angiex - LARVOL DELTA

AGX101: A TM4SF1-directed tubulin inhibitor conjugate in ongoing first-in-human trial including GI cancers. (ASCO-GI 2025) - P1 | "AGX101, targeting the TM4SF1 antigen, represents a promising new approach in cancer therapy. The preclinical data suggest that AGX101 could provide a significant therapeutic benefit by novel and differentiated mechanisms of action, namely selectively targeting the tumor vasculature and potentiating immune-based therapies. Further clinical development of AGX101 is ongoing and initial outcome data will become available by the conference."

IO biomarker • P1 data • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • IFIT3 • TM4SF1

Abzena Supplies Clinical Trial Material for Angiex's Phase I Study of AGX101, a First-in-Class TM4SF1-directed ADC (PRNewswire) - "Angiex...announced that patient dosing has begun for their Phase 1 clinical trial of AGX101, a first-in-class TM4SF1-directed Antibody-Drug Conjugate (ADC). Angiex partnered with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, to support the development, manufacture and supply of clinical trial material for the study....The Phase 1 study for AGX101 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."

Licensing / partnership • Trial status • Solid Tumor

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Angiex, Inc.

Metastases • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

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 (GlobeNewswire) - "Angiex...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....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."

IND • New P1 trial • Solid Tumor