SHANGHAI, China, August 7, 2018 – Antengene Corporation announced that it has officially launched patient enrollment of ATG-008 in Taiwan and South Korea, the Phase II clinical study on a new generation of TORC1/TORC2 kinase dual-targeted inhibitors acting on the mTOR pathway for Hepatocellular Carcinoma(HCC), and the first patient was successfully enrolled and administrated at the Taipei Medical University Hospital(with Dr. Gao Weiyu as lead investigator) on August 7. The main objective of this clinical trial is to assess pharmacokinetic characteristics, safety and efficacy of ATG-008 in patients with advanced liver cancer.
“We are very pleased that an advanced liver cancer patient was firstly and successfully enrolled in this Multi-Regional Clinical Trial (MRCT) and administrated, which is our first step in developing a TORC1/TORC2 dual-targeted inhibitor.” said Dr. Jay Mei, founder of Antengene, “Previously, we have completed ATG-008 clinical studies of 452 subjects for 7 malignant tumors, including liver cancer and neuroendocrine tumors in the United States, showing unique advantages in safety, tolerance and efficacy. ATG-008 has obvious clinical effect on liver cancer caused by hepatitis B virus positive (HBV+), which is of great significance to Asian patients. We want to provide a new treatment for people with liver cancer.”
At present, Antengene has several studies in phase II/III clinical trial stage, and the indications cover three areas: solid tumor, hematological tumor and viral infection. ATG-008 is Antengene’s first innovative drug approved for clinical research in the field of solid tumor, and the first drug of similar ones in the world to enter a clinical study of advanced liver cancer. Antengene is carrying out the clinical development of ATG-008 as both monotherapy and combination therapy for the treatment of a wide range of solid tumors. 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 trial. On May 25-26, 2018, the ATG-008-HCC-001 TORCH (trial name) Clinical Trial Launch Ceremony and Researchers Conference was held in Hangzhou, China, marking the official start of Antengene’s Asia-Pacific Multi-Regional Clinical Trial in Taiwan, China, Chinese mainland and South Korea.
According to Professor Qin Shukui, lead investigator of the ATG-008 TORCH clinical trial, “China has 460,000 new cases each year, with 55% of the global incidence and more than half of the world’s deaths. Due to the high heterogeneity of liver cancer, many newly developed drugs failed in clinical trials, thus so far there are few innovative drugs to treat advanced liver cancer. ATG-008, as a new TORC1/2 dual-targeted inhibitor, will bring hope to liver cancer patients in China and other Asia countries. The first patient enrollment in Taiwan is of great importance to ATG-008 and patients in Asia Pacific. The early and high-quality completion of the ATG-008 TORCH clinical trial will bring new treatments to patients with HBV+ HCC. “
According to professor Chen Pei-Jer of College of Medicine of National Taiwan University, an important researcher participating in clinical trial of ATG-008 in Taiwan, presiding over and being responsible for research on the exploration and analysis of ATG-008 biomarker methods, the first successful patient enrollment in Taiwan is of great significance for the entire multi-regional clinical trial of ATG-008. He will work with clinical researchers from Chinese mainland, South Korea and the United States for the success of the clinical trial of ATG-008.
Dr. Gao Weiyu, lead investigator of the Taipei Medical University Hospital, said, “We are pleased to be the center for the first patient enrollment of TORCH clinical trial. We hope to provide a new treatment for patients with advanced liver cancer more likely to occur in the Asia Pacific. “
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.