AU409 / Auransa, Lee's Pharm - LARVOL DELTA

AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease (clinicaltrials.gov) - P1 | N=36 | Suspended | Sponsor: University of Southern California | Recruiting ➔ Suspended

First-in-human • Trial suspension • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: University of Southern California | Trial completion date: Mar 2027 ➔ Mar 2028 | Trial primary completion date: Mar 2026 ➔ Mar 2027

First-in-human • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Early clinical activity and tumor transcriptional modulation of AU409, a first-in-class transcription regulator, in advanced solid tumors and hepatocellular carcinoma: Results from two phase I studies (AACR 2026) - P1 | "AU409, a novel transcription regulator, has a manageable safety profile in two ongoing phase I studies. The partial response and prolonged stability in pts with HCC who have progressed on one or more prior lines of therapy is encouraging and consistent with preclinical data. Exploratory evidence of transcriptional downregulation in tumor samples provides early proof-of-concept about the mechanism of AU409."

Clinical • IO biomarker • Metastases • P1 data • Hepatocellular Cancer • Oncology • Solid Tumor • CCL20

AU409-LEES-2021-03: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Lee's Pharmaceutical Limited | Trial completion date: Aug 2026 ➔ Dec 2025

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Lee's Pharmaceutical Limited

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

AI-Biopharma Auransa Announces Successful First Patient Dosed in Phase 1 Clinical Trial for Liver Cancer - "'Despite the higher response rates seen with immunotherapy combinations, when compared to TKIs, most patients will develop resistance to treatment,' said Dr. El-Khoueiry. 'In second line treatment and beyond, TKIs like sorafenib offer limited efficacy and the potential for significant toxicity. This leaves a substantial gap for new, improved therapies for liver cancer. We look forward to seeing how the AU-409 program progresses to address these unmet patient needs.'"

Media quote

AI-Biopharma Auransa Announces Successful First Patient Dosed in Phase 1 Clinical Trial for Liver Cancer (EIN News) - "Auransa...announced dosing of the first patient in its Phase 1 clinical trial to evaluate AU-409 as a treatment for patients with advanced liver cancers or solid tumors affecting the liver. The patient was treated at the USC Norris Comprehensive Cancer Center where Anthony El-Khoueiry, MD is the principal investigator on the trial."

Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor