Therapy Areas: Respiratory
GenFleet Therapeutics' GFH018 clinical trial applications receive Chinese regulatory approval
25 July 2022 -

GenFleet Therapeutics, a China-based clinical-stage biotechnology company, announced on Friday that it has received approval from China's National Medical Products Administration (NMPA) for the GFH018 Clinical Trial Applications (CTAs) in two clinical studies for combination therapies.

The two clinical studies include a phase Ib/II trial of GFH018 with PD-1 inhibitor treating patients with advanced solid tumours and a phase II trial of GFH018, PD-1 inhibitor with concurrent chemoradiotherapy treating patients with locally advanced and unresectable non-small cell lung cancer (NSCLC). Both studies are multi-centre, single-arm, and open-label trials aimed at assessing the safety/tolerability and efficacy of GFH018 in combination therapies.

Shanghai Oriental Hospital and Sun Yat-Sen University Cancer Center are to head the phase Ib/II study assessing the combination of GFH018 and anti-PD-1 monoclonal antibody carried out in more than 20 domestic hospitals. The safety/tolerability and efficacy of combination of GFH018, anti-PD-1 monoclonal antibody, concurrent chemoradiotherapy will be assessed in the phase two study, which will be carried out at more than 10 hospitals including West China Hospital of Sichuan University, Peking Union Medical College Hospital.

The company has completed a phase one trial of the product monotherapy treating solid tumours in early 2022, and the data will soon be presented at a relevant international medical conference.