Biopsy of a highly differentiated squamous cell carcinoma of the mouth. Credit: KGH.

Exicure has added four new clinical trial sites for its Phase Ib/II trial of AST-008 for the treatment of various cancer types.

The sites are based in the US, including Dana Farber Cancer Institute in Massachusetts, Holden Comprehensive Cancer Center at the University of Iowa, John Wayne Cancer Institute at Providence St John’s Health Center in California, and Sylvester Comprehensive Cancer Center at the University of Miami in Florida.

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Exicure CEO Dr David Giljohann said: “We are encouraged by the results of our Phase I clinical trial, which demonstrated that our drug is well-tolerated and activates key immune cells and signals.

“We are encouraged by the results of our Phase I clinical trial, which demonstrated that our drug is well-tolerated.”

“Eligible patients will be able to enrol in trial sites in the US.”

The initial stage of the open-label Phase Ib/II trial includes a dose-finding Phase Ib stage, where AST-008 is expected to be evaluated in combination with an anti-PD-1 therapy pembrolizumab (Keytruda).

The Phase Ib stage is set to be followed by a Phase II expansion stage.

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Exicure aims to enrol patients with superficial injectable tumours as part of the Phase Ib portion of the trial.

Patients will be prioritised as per their cancer types such as Merkel cell carcinoma, cutaneous squamous cell carcinoma, melanoma, and squamous cell carcinoma of the head and neck.

Exicure is scheduled to provide preliminary data from the Phase Ib portion of the trial later this year.

The company is currently developing AST-008 as a toll-like receptor nine (TLR9) activator.