Australian Therapeutic Goods Administration Approves the First Phase I Trial of ATG-017 for the Treatment of Patients with Advanced Solid Tumors and Hematological Malignancies

SHANGHAI and MELBOURNE,Australia,Aug.13,2020 -- Antengene Corporation,a leading innovative hematology and oncology-focused biopharmaceutical company,announced today the authorization of the first-in-human trial of ATG-017 (ERASER trial) by the Australian Therapeutic Goods Administration (TGA). ATG-017 is a potent and selective small molecule extracellular signal--regulated kinases 1 and 2 (ERK1/2) inhibitor. The study will enroll patients with advanced solid tumors and hematological malignancies. Today's milestone marks the first TGA trial authorization for Antengene and is the first clinical trial for ATG-017 globally.

ATG-017 is an oral,potent and highly selective inhibitor of ERK1/2,which are related protein-serine/ threonine kinases that function as the terminal kinases in the RAS-RAF-MEK-ERK signal transduction cascade. This pathway participates in the control of numerous processes which include apoptosis,cell proliferation,and cellular immune response. In preclinical studies,ATG-017 has proven to regulate a large variety of cellular processes by targeting ERK1/2 and has shown to be effective in inhibiting the viability of tumor cell lines in vitro as well as the tumor growth in vivo.

"This first human trial for ATG-017 in Australia is a significant step for our company's global clinical strategy and we will initiate overseas trials continuously for a number of novel drugs in our pipeline in the near future," said Dr. Jay Mei,M.D.,Ph.D.,Founder,Chairman and CEO of Antengene. "Our vision is to treat patients beyond borders. For Australian patients with life-threatening diseases and patients around the world,we are passionately working to continue to develop and commercialize more novel therapies to make a difference in patient lives."

"Aberrations in the MAPK pathway are amongst the most common in malignant cancer,so developing effective drugs targeting this pathway remains a high priority. We are excited to begin this trial with the ERK-targeting agent ATG-017,and bring together our group of highly experienced Australian investigators and sites to begin this collaboration with Antengene," said Associate Professor Jayesh Desai,Head of the Phase I/ Early Drug Development Program at the Peter MacCallum Cancer Centre.

"The RAS-MAPK pathway is a major player in a range of largely incurable hematological malignancies,so the potential to effectively target it with ATG-017 represents an exciting opportunity for Australian cancer patients. We very much look forward to collaborating with Antengene on this new trial," said Professor Andrew Spencer,Head of the Malignant Haematology and Stem Cell Transplantation Service at the Alfred Hospital,Melbourne.

In November 2019,Antengene entered into a licensing agreement with AstraZeneca (LSE/STO/NYSE: AZN) under which Antengene has been granted the exclusive global rights to further develop,manufacture and commercialize AZD0364 (ATG-017).ATG-017 is currently being studied in clinical trials for the treatment of various solid tumors and hematological malignancies.

About ATG-017

ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors,non-Hodgkin's lymphoma,acute myeloid leukemia (AML) and multiple myeloma.

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. Antengene has built a product pipeline of 12 clinical and pre-clinical stage programs,obtained 9 IND approvals with9 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 region and around the world through our research & development and commercialization of first-in-class/best-in-class cancer medicines. For more information,please visit www.antengene.com.

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