Pharma Focus Asia

Antengene Announces First Patient Dosed in Phase II Trial of ATG-008 (Onatasertib) in Patients with Advanced Solid Tumors with Specific Genetic Alterations

Monday, April 12, 2021

Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the first patient has been dosed in a phase II trial (BUNCH) in China of ATG-008 (onatasertib), a second-generation mTORC1/2 inhibitor, for the treatment of advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations. The purpose of the single-arm, open-label trial is to evaluate the safety and efficacy of ATG-008 in patients with such advanced solid tumors that may be predictably sensitive to inhibition of mTORC1/2.

According to the latest report by the World Health Organization, there were an estimated 19.3 million newly diagnosed cancer cases and 10 million cancer-related mortalities in 2020 globally. Furthermore, the report also projected a 47% increase in cancer-related disease burden in the coming 20 years. China now ranks number one in both cancer incidence and mortality rates[i]. This reminds us of the daunting challenges in cancer treatment and the ever more urgent need for effective novel anti-cancer therapies in China.

There is a close association between the mTOR signaling pathway and genetic mutations in NFE2L2, STK11 and RICTOR. ATG-008, a potent selective inhibitor of mTOR kinase that is currently under clinical development, may induce the cell death of multiple tumor types through the dual-inhibition of mTORC1 and mTORC2. Therefore, mTOR inhibitor ATG-008 has the potential to offer a new treatment option for patients with advanced solid tumors with such genetic alterations. Moreover, preclinical and clinical data also demonstrated the potent antitumor activity of ATG-008 in multiple tumor types.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "There are urgent needs for more effective treatment options for patients with various advanced solid tumors. We believe ATG-008 has strong potential to address a serious unmet medical need in a hard-to-treat group of cancers. This trial also marks an important step in the development of our innovative pipeline for the treatment of patients with solid tumors in China. We look forward to producing important clinical data to guide the further development and continue to demonstrate Antengene's leadership in drug development for mTORC1/2 inhibitors."      

Antengene has initiated several clinical trials in China and other Asia Pacific countries and regions with ATG-008 in the treatment of advanced hepatocellular carcinoma (HCC), advanced non-small-cell lung cancer (NSCLC) and in combination with an anti-PD-1 antibody in advanced solid tumors including hepatocellular carcinoma (HCC).

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