China – based Jiangxi Jemincare Group has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug JYB1907. The monoclonal antibody (mAb) targets glycoprotein A dominant repeat (GARP) and transforming growth factor – β1 (TGF – β1) and is being developed for the treatment of locally advanced or metastatic solid tumors.
Mechanism of Action and Preclinical Results
GARP is a Type I transmembrane cell surface docking receptor that is highly expressed on activated regulatory T cells (Tregs) and platelets. It mediates the activity of TGF – β1, which is a major cause of drug resistance during immune checkpoint inhibitor treatment. JYB1907 specifically binds to the GARP/TGF – β1 complex, blocking GARP – mediated TGF – β1 signaling. This action reverses the immunosuppressive effects in the tumor microenvironment and enhances the anti – tumor immune response.
Preclinical research has demonstrated a favorable safety and efficacy profile for JYB1907. In various human tumor cell and PBMC – humanized tumor animal models, JYB1907 showed significant tumor growth inhibition. Notably, more than half of the mice in the ZR – 75 – 1 human breast cancer model experienced complete tumor regression. Additionally, when combined with a PD – L1 antibody, JYB1907 induced complete tumor regression in some mice in the A375 human melanoma model, significantly outperforming the anti – tumor effect of the PD – L1 antibody alone. These results highlight the potential pharmacodynamic enhancement effect of the JYB1907 combination therapy.
Company Background and Pipeline
Founded in 1999, Jemincare is a leading biopharmaceutical company focused on the research and development of innovative therapies for kidney disease, cancer, cardiovascular and cerebrovascular diseases, respiratory diseases, anti – infection, and pain management. The company’s robust pipeline includes over 20 Category 1 drug candidates, reflecting its commitment to addressing significant unmet medical needs across multiple therapeutic areas.-Fineline Info & Tech
