Press Release

Jan 03, 2020

News Flash! The PAK4/NAMPT Dual Target Oral Inhibitor, ATG-019, Passed the Review of Investigational New Drug (IND) by Taiwan, China

Shanghai, China — Antengene Corporation announced on January 3, 2020 that the Food and Drug Administration, Ministry of Health and Welfare, Taiwan (abbreviated as TFDA) has recently approved the commencement of its phase I open-label clinical trial for the PAK4/NAMPT dual target oral inhibitor ATG-019.

The purpose of this trial is to evaluate the safety and tolerability of ATG-019 (PAK4/NAMPT dual target inhibitor) in patients with advanced solid tumors or non-Hodgkin's lymphoma. This is a phase I study that will evaluate the efficacy of ATG-019 monotherapy or ATG-019 combined with niacin ER (vitamin B3) in advanced solid tumors or non-Hodgkin's lymphoma in the absence of standard therapy.

ATG-019 is the world's first dual-target and non-competitive oral small molecule drug that targets the p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and the nicotinamide phosphoribosyltransferase (NAMPT or PBEF/visfatin). This drug inhibits tumor growth by regulating the activity of the two proteins to achieve tumor clearance. The clinical approval of this product has important social significance in the current health environment in which the incidence and mortality rate of tumors are increasing year by year.

"Tumor cells are dependent on the PAK4 and NAMPT pathways. ATG-019 exhibits potent anti-proliferation activity on cancer cells through precise targeted therapy. Antengene's R&D team is currently investigating the treatment regimen of ATG-019 in solid tumors and non-Hodgkin's lymphoma". Dr. Mei Jianming, founder, chairman, and CEO of Antengene stated that, "As the support for locally created drugs increases, many antineoplastic drugs are being developed and redeveloped currently, which expands the number of indications. In the past year, Antengene successfully obtained the clinical approvals of multiple Class 1 new drugs that treat relapsed or refractory multiple myeloma, diffuse large B-cell lymphoma, peripheral T-cell and NK/T cell lymphoma, advanced solid tumors or non-Hodgkin's lymphoma. However, this is only the beginning and only continuous innovation and effort can make the marketing of new drugs possible to provide therapeutic options for more patients."

About Antengene

Antengene is a China-and-U.S. based biopharmaceutical company focusing 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 drugs and other treatments for patients in China/Asia and around the world. Antengene's pipeline includes six clinical stage products: ATG-010 (selinexor), in combination with the corticosteroid dexamethasone, has been approved by the U.S. Food and Drug Administration, and is currently in registration study in China for the treatment of adult patients with relapsed or refractory multiple myeloma. The drug 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 as well as clinical studies in 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 colorectal, prostate, NHL, MDS and other solid and hematological malignancies. ATG-527 is being explored for multiple anti-viral indications, including Epstein-Barr virus (EBV) related diseases. 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, NHL and AML. The drug discovery team of Antengene focuses on the development of first-in-class novel molecules with six projects in pre-clinical development, including small molecule, monoclonal and bi-specific antibodies.