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Exicure Granted Two Fast Track Designations for Cavrotolimod (AST-008) from the U.S. Food and Drug Administration
CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical
About this update from Exicure, Inc.
[{"type":"text","content":" CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nExicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations for its clinical product candidate, cavrotolimod (AST-008), for two development programs:\n\n\ncavrotolimod in combination with anti-programmed death-1 (PD-1) therapy for the treatment of patients with locally advanced or metastatic Merkel cell carcinoma (MCC) refractory to prior anti-PD-1 blockade; and\n\n\ncavrotolimod in combination with anti-PD-1/anti-PD-ligand 1 (anti-PD-(L)1) therapy for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) refractory to prior anti-PD-(L)1 blockade\n\n\nFast Track is a designation granted by the FDA that is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug candidate to address this medical need.\n\n\"There is an urgent need to investigate novel immunotherapeutic agents such as cavrotolimod that can be given to enhance the clinical efficacy of immunotherapy, particularly in patients with refractory solid tumors,\" said Dr. Adil Daud, M.D., Clinical Professor at UCSF Helen Diller Family Comprehensive Cancer Center and principal investigator in the Phase 1b/2 clinical trial of cavrotolimod.\n\nCavrotolimod is a spherical nucleic acid toll-like receptor 9 (TLR9) agonist designed to robustly activate the patient’s innate and adaptive immune systems in order to potentially induce potent anti-cancer immune responses. The Phase 1b dose-escalation stage of the open-label, multi-center trial was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab in patients with advanced solid tumors. The patients from the Phase 1b stage included those with advanced or metastatic MCC, head and neck squamous cell carcinoma, CSCC, melanoma and leiomyosarcoma. A summary of the key highlights from the Phase 1b stage of the trial include:\n\n- No observe...