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Linnaeus Therapeutics announced that the U.SFood and DrugAdministration (
FDA) has granted LNS88801 fast track designations for the treatment of metastatic or non-removable melanoma patients with disease progression after anti-PD-1 or anti-PD-L1 treatmentLNS8801 is currently being evaluated in a Phase 1 clinical trial for advanced cancer patientsThe company expects to begin its Phase 2 clinical study this year, with LNS8801 as a single therapy or a combination of targeted therapiesLNS8801 is a powerful agonisant that targets G-protein estrogen receptors (GPER)GPER is widely expressed in tumors, and excited GPER can both stop the spread of cancer and activate the body'simmuneresponseThe activity of LNS8801 depends on the expression level of the GPERGPER activation inhibits a variety of tumor-related genes, such as c-Myc and PD-L1In preclinical cancer models, LNS8801 exhibits strong antitumor activity in a wide range of tumor types, rapidly shrinking tumors and inducing immune memoryLNS8801 monotherapy has shown significant antitumor activity and has also shown a role when used in combination with targeted therapies, chemotherapy and immunotherapyLNS8801 is currently undergoing Phase 1/2 clinical trials in patients with advanced cancer in six comprehensive cancer centers in the United States