Benzinga | Apr 6, 2021 05:37AM EDT

Antengene Announced NMPA Approval of IND Application for ATG-019 in Patients with Advanced Solid Tumors or Non-Hodgkin's Lymphoma; ATG-019 is an Oral Dual PAK4/NAMPT Inhibitor Developed by Karyopharm Therapeutics

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical trial to evaluate safety and tolerability of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL) in China.

As an orally bioavailable dual PAK4/NAMPT inhibitor, ATG-019 can lead to antitumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and ultimately cell apoptosis. Hematological and solid tumor cells that are dependent on both PAK4 and NAMPT pathways may be susceptible to single-agent anti-tumor activity by ATG-019. ATG-019 has clear preclinical anti-tumor activity and a superior pharmacokinetics (PK) and safety profile making it an attractive novel drug candidate. Antengene has recently been conducting a Phase I clinical trial (TEACH) of ATG-019 in advanced solid tumors and NHL in Taiwan.

"The NMPA's approval of the IND application for ATG-019 indicates the potential of this drug to be applied to Chinese patients. We look forward to initiating the first clinical trial of ATG-019 in mainland China," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "ATG-019 is an orally available dual PAK4/NAMPT inhibitor that achieves synergistic antitumor effects through the co-inhibition of the two pathways. We believe that ATG-019, as a novel agent under investigation, can potentially provide an additional treatment option for patients with advanced solid tumor and NHL."

About ATG-019

ATG-019 is a global first-in-class oral dual PAK4/NAMPT inhibitor developed by Karyopharm Therapeutics Inc. (NASDAQ:KPTI). Antengene reached an exclusive agreement of cooperation and authorization with Karyopharm and obtained the exclusive development and commercialization rights of ATG-019 in multiple Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and ASEAN countries.