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July 25, 2022

GenFleet gets China’s NMPA approval for early-phase cancer trials

The two multicentre, open-label trials will assess the safety/tolerability and efficacy of GFH018 plus other therapies.

GenFleet Therapeutics has received approvals from China’s National Medical Products Administration (NMPA) for the Clinical Trial Applications (CTAs) for two studies of GFH018 plus a PD-1 inhibitor to treat cancer.

A Phase Ib/II trial will analyse GFH018 in combination with a PD-1 inhibitor for advanced solid tumour patients.

The other study is a Phase II trial of GFH018, a PD-1 inhibitor along with immunochemotherapy and radiotherapy to treat locally advanced and unresectable non-small cell lung cancer (NSCLC) patients. 

An oral inhibitor of TGF-β R1, GFH018 entered into Phase I trial in 2019. 

Both multicentre, single-arm and open-label trials will assess the safety/tolerability and efficacy of GFH018 plus other therapies. 

The Phase Ib/II trial of GFH018 plus anti-PD-1 monoclonal antibody will be led by Shanghai Oriental Hospital and Sun Yat-Sen University Cancer Center.  

It will be carried out in more than 20 hospitals in the country. 

The Phase II trial of GFH018 plus anti-PD-1 monoclonal antibody, immunochemotherapy and radiotherapy will be carried out at more than 10 hospitals including West China Hospital of Sichuan University and Peking Union Medical College Hospital.  

In addition, the potential of the combination therapy to boost the immunosuppressive microenvironment and reduce radiotherapy and chemotherapy side effects will be analysed in this trial.

According to preclinical data, GFH018 demonstrated good anti-tumour properties against cancer cells in vivo and in vitro. 

GenFleet CEO Jiong Lan said: “GFH018 is a small molecule drug designed to specifically target and inhibit TGF-β R1, and the discovery and development of GFH018 truly reflects GenFleet’s strategy of novel mechanism-focused innovation in drug development. 

“GenFleet expects the development of the GFH018 to bring a novel therapy with great clinical benefit to cancer patients.”

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