Exicure Announces US Clinical Sites for Phase 1b/2 Oncology Trial

Source:  Exicure, Inc. 2/5/19

Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) constructs, today announced four of the clinical trial sites for the Company’s Phase 1b/2 trial of AST-008.

“Exicure is thrilled to announce the four initial sites for the Phase 1b/2 clinical trial to evaluate our immune system activating spherical nucleic acid in combination with Keytruda for the treatment of solid tumors,” said Dr. David Giljohann, Chief Executive Officer of Exicure. “We are encouraged by the results of our Phase 1 clinical trial, which demonstrated that our drug is well-tolerated and activates key immune cells and signals. Eligible patients will be able to enroll in trial sites in the US.”

The open-label Phase 1b/2 trial will begin with a dose finding Phase 1b stage in combination with the anti-PD-1 therapy pembrolizumab (KEYTRUDA®), followed by a Phase 2 expansion stage. In the Phase 1b, Exicure will enroll patients with superficial injectable tumors and will prioritize those with Merkel cell carcinoma, cutaneous squamous cell carcinoma, melanoma, and squamous cell carcinoma of the head and neck. Preliminary data from the Phase 1b stage of the trial are expected in late 2019.

The clinical trial sites are as follows:

• Dana Farber Cancer Institute (Boston, Massachusetts)
• Holden Comprehensive Cancer Center at the University of Iowa (Iowa City, Iowa)
• John Wayne Cancer Institute at Providence St. John's Health Center (Santa Monica, California)
• Sylvester Comprehensive Cancer Center at the University of Miami (Miami, Florida)

AST-008 is a toll-like receptor nine (TLR9) activator being developed by Exicure. More information on the Phase 1b/2 trial of AST-008 can be found at clinicaltrials.gov, under identifier number NCT03684785.

KEYTRUDA® (Pembrolizumab; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

About Exicure, Inc.
Exicure, Inc. is a clinical stage biotechnology company developing a new class of immunomodulatory and gene regulating drugs against validated targets. Exicure's proprietary spherical nucleic acid (SNA™) architecture is designed to unlock the potential of therapeutic oligonucleotides in a wide range of cells and tissues. Exicure's lead programs address inflammatory diseases, genetic disorders and oncology. Exicure is based outside of Chicago, IL. www.exicuretx.com