Press Release

Jun 22, 2019

Antengene obtaining Korean IND approval for ATG-008, a mTOR Kinase Dual-Targeted Inhibitor

SHANGHAI and SHAOXING, China - On June 22, 2018, Antengene announced that ATG-008, its innovative drug for the treatment of advanced hepatocellular carcinoma (HCC), has successfully passed the review of investigational new drug (IND) application by South Korean Ministry of Food and Drug Safety (MFDS). Previously, Antengene has obtained the IND approval from Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration respectively in March and June of the same year, and the Asia-Pacific Multi-Center Phase II, or TORCH, is about to have its first patient enrolled in July this year.

ATG-008, a new version of TORC1/TORC2 kinase dual-targeted inhibitors acting on the mTOR pathway, is Antengene’s first innovative drug approved for clinical trials in the Asia-Pacific region and is the first-of-its-kind in the world to conduct a clinical trial of advanced liver cancer. ATG-008 previously had 452 patients and some healthy volunteers in the clinical trial phase in the United States and the European Union, and performed excellently in prolonging the survival in the group of patients who had advanced liver cancer caused by the hepatitis B virus (HBV+) while already received the systematic treatment. Now, the clinical trial engaged in by multiple medical centers focuses on the safety, tolerability, pharmacokinetics, overall tumor response rate and survival assessment in patients having received at least one full treatment.

Currently, in addition to being approved for clinical trials of advanced liver cancer, ATG-008 is developed to serve both a monotherapy and a combination therapy for the treatment of multiple solid tumors and malignant blood tumors.

About Antengene

Antengene Corporation is a biopharmaceutical company focused on drug discovery, clinical development and the commercialization of innovative therapeutics to meet unmet medical needs. Antengene aims to provide the most advanced and first-in-class anti-cancer drug treatments for patients around 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. Antengene's pipeline includes six commercial and clinical stage products: ATG-010 (selinexor), in combination with the corticosteroid dexamethasone, has been approved by the U.S. Food and Drug Administration, for the treatment of adult patients with relapsed or refractory multiple myeloma. The compound is also in late clinical development for various other hematologic malignancies and solid tumors. ATG-008, a second-generation dual mTORC1/2 inhibitor, is in a multi-regional clinical trial for treatment of hepatocellular carcinoma and multiple other solid tumors. Two other Phase 1 and Phase 2 clinical stage drugs, ATG-016 and ATG-019, are being studied in multiple cancer types, including MDS, colorectal and prostate cancers. ATG-527 is being explored for multiple anti-viral indications, including respiratory syncytial virus (RSV), and Epstein-Barr virus (EBV) related diseases, etc. ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor, in clinical development for multiple solid tumors. Antengene drug discovery team focuses on development of first-in-class novel products.