GenFleet Therapeutics Announces Initiation of Phase I Trial for TGF-β R1 Inhibitor

Aug 01, 2019

August 1, 2019 (Shanghai, China) – GenFleet Therapeutics completed the site initiation visit of Phase I trial for its first product granted with IND approval earlier this year. Kicking off firstly in Shanghai Oriental Hospital, the clinical research for its TGF-β R1 inhibitor represents a positive milestone as GenFleet grows into a clinical-stage biotechnology company within 2 years of its startup.

Professor Ye Guo, director of Phase I clinical unit for this program, chaired the meeting where the team elaborated on the overall scheme, the workflow and major points of the project timeline. As the director of oncology department, Professor Jin Li will serve as principal investigator responsible for this clinical trial.

“TGF-β signaling pathway has been validated in recent years as crucial to regulating immune- microenvironment in cancer. Potential indications for molecules targeting this pathway span across multiple solid tumors in liver cancer, urothelial cancer, etc. As a small-molecule inhibitor, GenFleet's compound GFH018 was developed according to the molecular mechanism of TGF-β signaling pathway and will hopefully enrich therapeutic solutions for patients resistant to previous immunotherapies with poor prognosis. GFH018 also offers an alternative for combination strategies involving immune checkpoint inhibitors.” said Professor Jin Li.

“Preclinical data show evidence of GFH018's good anti-tumor properties against cancer cells in vivo and in vitro. Besides, translational and mechanistic studies have confirmed it effectively acts on TGF-β signaling pathway and synergizes with checkpoint inhibitors. Therefore, our confidence in its prospects is reinforced considering that the pathway is overexpressed in various solid tumors. Thanks to our perseverance and expertise, we smoothly performed all processes of IND application for GFH018 less than 2 year after GenFleet was founded and our submission was approved without supplementary dossiers. We look forward to its clinical progress and benefits to patients.” said Dr. Jiong Lan, Co-founder and Chief Executive Officer of GenFleet Therapeutics.