Antengene Corporation Announces TFDA Approval of IND Application for a Phase II Study of ATG-008, a Next Generation mTOR Inhibitor, in Patients with Late-stage Hepatocellular Carcinoma (HCC)

Mar 26, 2018View PDF


On March 26, 2018, Antengene Corporation, a China-based biopharmaceutical company that focuses on introducing cutting-edge treatments to China and other Asian markets, announces today that Taiwan Food and Drug Administration (TFDA) has approved an investigational new drug (IND) application for a Phase II study (TORCH) of ATG-008, a next generation mTOR inhibitor, in patients with late-stage hepatocellular carcinoma (HCC). This marks beginning of the first multi-regional clinical trial (MRCT) of Antengene Corporation in Asia Pacific. The study is also the first clinical development program of an oral dual TORC1/2 inhibitor in patients with late-stage HCC globally, which makes ATG-008 potentially a first-in-class agent in this disease area.

Antengene Corporation plans to conduct clinical development of ATG-008 as both monotherapy and in combination with other novel therapeutics in multiple types of solid tumor. The currently approved trial is the first program of ATG-008 that aims to study the safety and efficacy of the dual TORC1/2 inhibitor in patients with late-stage HCC.

About ATG-008

ATG-008, is an experimental oral mammalian target of rapamycin (mTOR) kinase inhibitor which inhibits both TORC 1 and 2, and has demonstrated to induce tumor cell apoptosis and decrease tumor cell proliferation. It is currently under Phase II clinical development in multiple countries and regions in Asia, and potentially a first-in-class agent in late-stage hepatocellular carcinoma (HCC). Professor Michael N. Hall, who discovered the nutrient-activated TOR proteins and their central role in the metabolic control of cell growth, was granted 2017 Albert Lasker Basic Medical Research Award.

About Antengene

Antengene Corporation is a biopharmaceutical company focused on R&D and commercialization for innovative drugs. Antengene aims to provide the most advanced anti-cancer drug treatments for patients in Asia and the world. On April 13, 2017, Celgene Corporation (NASDAQ: CELG), a global leading innovative biopharmaceutical company became a long-term strategic partner and obtained an equity position in Antengene.