Press Release

Sep 21, 2018

Antengene Presents a Series of Reports on TORC1/TORC2 Dual-Targeted Inhibitor ATG-008 at the 21st Annual Meeting of Chinese Society of Clinical Oncology

On September 21, 2018 (Beijing time), Antengene Corporation presented a special report entitled “Novel TORC1/2 Inhibitor for Treatment of Hepatocellular Carcinoma (HCC)” at the 21st annual meeting of Chinese Society of Clinical Oncology (CSCO) in Xiamen, China. Meanwhile, Dr. Jennifer Wu, director of Bellevue Cancer Center and professor of New York University School of Medicine, made an oral presentation on “Phase II Clinical Studies on Oral Administration of TORC1/TORC2 Inhibitors (ATG-008, originally CC-223) in Advanced Hepatocellular Carcinoma (HCC)”. At the special invitation of CSCO, Dr. Andrew Zhu, professor of Medicine at Harvard Medical School, director of Liver Cancer Research at Massachusetts General Hospital and world-renowned liver cancer expert, made a special report on the progress of the latest treatments for liver and bile duct cancers.

Dr. Jay Mei, founder, chairman and CEO of Antengene, hosted the special report on“Novel TORC1/2 Inhibitor for Treatment of Hepatocellular Carcinoma”. According to Dr. Mei, “Antengene is currently conducting a multi-regional clinical trial named ‘TORCH’ in Chinese mainland, Taiwan, China and South Korea. At present, 5 patients have already been enrolled in trials in South Korea and Taiwan, China. Patients in Chinese mainland will also participate in the next 1-2 months. Previously, ATG-008 has completed clinical studies in 7 tumors like liver cancer and neuroendocrine tumors with a total of 452 subjects in the United States, showing its unique advantages in terms of safety, tolerance and efficacy. ATG-008 has obvious clinical effect on HBV+ liver cancer, which is of great significance to Asian patients. We believe that we will provide patients with a new treatment superior to the existing mTOR inhibitors on the market. ”

According to Dr. Jennifer Wu, “PI3K/mTOR pathway disorders are frequent in multiple tumors. ATG-008 is an ATP-competitive inhibitor of mTOR kinase that inhibits mTORC1 and mTORC2 to prevent up-regulation of the feedback pathway. Current clinical trial results show that ATG-008 has a higher ORR (Objective Response Rate) for HBV+ patients, and its DCR (Disease Control Rate) and OS (Overall Survival) results are encouraging (ORR = 25%, DCR = 91%, OS = 13 months). In patients without disease progression, the course of treatment of ATG-008 was longer than that of Sorafenib and its exposure prolonged the overall survival period. Furthermore, such treatment was not related to follow-up treatment and allowed a significantly long OS. At the same time, ATG-008 has good tolerance in patients with advanced hepatocellular carcinoma.”

Antengene has carried out clinical development of ATG-008 monotherapy and combination therapy for advanced liver cancer. ATG-008 has been approved by Taiwan Food and Drug Administration (TFDA), Korea's Ministry of Food and Drug Safety (MFDS) and China's National Medical Products Administration (NMPA) for Phase II clinical trials. In May 2018, the ATG-008-HCC-001 TORCH (trial name) Clinical Trial Launch Ceremony and Researchers Conference was held in Hangzhou, China. In August 2018, the first patient of ATG-008 was enrolled and administrated at the Taipei Medical University Hospital.

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.