Jinfang Pharmaceutical's TGF-β R1 inhibitor initiates the first global multi-center phase Ib/II clinical study

Recently, Jinfang Medicine announced that its self-developed TGF-β R1 inhibitor GFH018 has entered a global multi-center phase Ib/II clinical study, and GFH018 tablets and toripalimab will be developed for patients with advanced solid tumors.
Of the combined drug test
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At present, the first case of metastatic sigmoid colon adenocarcinoma has been administered for the first time in Perth, Australia
.

At the same time, the company has recently obtained a Phase Ib/II combined drug clinical trial license issued by the Food and Drug Administration in Taiwan
.

The TGF-β pathway is an important target in a variety of solid tumor tissues.
So far, no related drug has been approved for marketing in the world.
GFH018 has a broad application prospect in the treatment of solid tumors with low response rates of PD-1 inhibitors
.

 GFH018 is an oral small molecule TGF-βR1 inhibitor.
It is a drug independently developed by Jinfang Medicine and entered the phase I single-drug clinical trial in 2019
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At present, GFH018 has shown good anti-tumor efficacy and druggability in a variety of human cell lines and disease animal models
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In addition, translational medicine and mechanism studies have confirmed that GFH018 can effectively inhibit the TGF-β pathway and regulate the tumor microenvironment, achieving a synergistic effect with immune checkpoint inhibitors
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 In the microenvironment of advanced solid tumors, TGF-β signaling pathway can promote epithelial cell-mesenchymal transition and metastasis, induce tumor stem cell formation and function maintenance, inhibit anti-tumor immune response, increase angiogenesis and tissue fibrosis, and promote tumors Progress
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 In patients with various solid tumors such as hepatocellular carcinoma, glioma, colorectal cancer, lung cancer, pancreatic cancer, urothelial cancer, blood and tumor tissues were found to have high expression of TGF-β pathway-related genes and their gene expression levels It is positively correlated with poorly differentiated and malignant tumors, and poor prognosis of patients
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 This global multi-center open clinical study will mainly evaluate the safety/tolerability of the combination of GFH018 and teriprizumab inhibitor, as well as the pharmacokinetic characteristics of GFH018 and the efficacy of the combination
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GFH018 single-agent phase I clinical trials have shown good drug safety, and pre-clinical animal experimental data have suggested the anti-tumor effect of low-dose GFH018 in combination with PD-1 inhibitors
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 Dr.
Wang Yu, Chief Medical Officer of Jinfang Medicine, said that the TGF-β pathway has been clinically confirmed as one of the key mechanisms for regulating the immune microenvironment.
Related drugs can be applied to a variety of tumor indications with immunotherapy resistance and poor prognosis.
For TGF-β pathway related antibody drugs, GFH-018 has a differentiated small molecule design and specifically targets the TGF-βR1 receptor
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Based on the data of phase I single-drug clinical trials, GFH018 is expected to inhibit the growth of fibroblasts, regulate multiple tumor microenvironments, and increase the response rate of PD-1 inhibitors in the process of combination medication
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