Antengene announces China’s NMPA approval for IND application for ATG-019 clinical trial

Antengene has announced that China’s National Medical Products Administration (NMPA) has given approval to investigational new drug (IND) application for Phase I clinical trials of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin’s lymphoma (NHL).

Developed by Karyopharm Therapeutics, ATG-019 is a global first-in-class, oral of p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT).

Clinical-stage biopharmaceutical company Antengene signed an agreement with Karyopharm for the clinical development, manufacturing and commercialisation of ATG-019 in Greater China, Australia, New Zealand, South Korea, and the ASEAN countries.

The company has recently begun conducting a Phase I clinical trial to evaluate safety and tolerability of ATG-019 in advanced solid tumours and NHL in Taiwan, China Region of China.

It is also planning to conduct a combination study of ATG-019 and anti-PD-1 antibody to treat anti-PD-1 resistant patients.

Antengene founder, chairman and CEO Jay Mei said: “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.

“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.”

The company noted that the dual PAK4/NAMPT inhibitor can lead to antitumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and cell apoptosis.