Antengene Announces IND Approval by NMPA to Initiate a Phase II Clinical Trial of ATG-008 for the Treatment of Advanced Solid Tumors with Specific Genetic Alterations

Aug 24, 2020View PDF

SHANGHAI, China and PHILADELPHIA, U.S.– August 24, 2020 – Antengene Corporation, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and best-in-class therapies in oncology and hematology, today announced that the National Medical Products Administration (NMPA) has approved a phase II trial of ATG-008 for the treatment of patients with advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations. In addition to this trial, ATG-008 has also been approved for clinical trials in China and other Asia regions 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).

 

According to the data released by the National Cancer Center in 2018, China is the country with the highest cancer incidence and mortality rate. ATG-008 is a second-generation oral mammalian target of rapamycin (mTOR) kinase inhibitor that inhibits both mTORC1 and mTORC2, which ultimately leads to apoptosis and reduces tumor cell proliferation. Preclinical and clinical studies demonstrated that dual targeted inhibition of mTORC1/2 has extensive antitumor activity in a variety of tumor types.

 

“The successful clinical trial applications for ATG-008 in China and other Asia regions fully demonstrate the efficient execution of our team at Antengene and the passion to bring innovative therapies to cancer patients. We believe targeting the mammalian target of rapamycin (mTOR) protein is a promising strategy for cancer therapy and we are looking forward to increasing patient access to novel treatment options by conducting various clinical trials with ATG-008 which is expected to demonstrate the potential of this dual mTORC1/2 dual targeted inhibitor across various cancers.” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene.

 

About ATG-008

ATG-008 (onatasertib) is a second-generation mTORC1/2 inhibitor, for which development and commercialization rights in Asia Pacific were licensed from Celgene (now Bristol Myers Squibb). ATG-008 is currently being studied in multi-regional clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), as well as non-small-cell lung cancer (NSCLC), advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations, gynecological malignancies and other cancers as a single agent or in combination with an anti-PD-1 antibody.

 

About Antengene

Antengene is a biopharmaceutical company with integrated drug discovery, clinical development, manufacturing and commercialization anchored in the Asia Pacific region and with a global layout, aiming to provide the most advanced first-in-class/best-in-class anti-cancer drugs and other treatments for patients in China, the rest of Asia and around the world. In April 2017, Celgene (now Bristol-Myers Squibb), a global leading innovative biopharmaceutical company became a founding partner and obtained an equity position as an investor in Antengene. Since our inception, Antengene has built a product pipeline of 12 clinical and pre-clinical stage programs, obtained 9 IND approvals with 9 ongoing cross-regional clinical trials in the Asia Pacific region. The vision of Antengene, “Treating Patients Beyond Borders”, is to meet the unmet medical needs of patients in the Asia Pacific regions and around the world through research & development and commercialization of first-in-class/best-in-class drugs. For more information, please visit www.antengene.com.

 

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