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

Tuesday, February 5th 2019 at 12:00pm UTC

(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, 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

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.

Forward Looking Statements

This press release contains forward-looking statements (including within
the meaning of Section 21E of the United States Securities Exchange Act
of 1934, as amended, and Section 27A of the United States Securities Act
of 1933, as amended) concerning the Company, the Company’s technology,
potential therapies and other matters. Forward-looking statements
generally include statements that are predictive in nature and depend
upon or refer to future events or conditions, and include words such as
“may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,”
“look forward,” and other similar expressions among others. Statements
that are not historical facts are forward-looking statements.
Forward-looking statements are based on current beliefs and assumptions
that are subject to risks and uncertainties and are not guarantees of
future performance. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: unexpected costs, charges or
expenses that reduce cash runway; that Exicure’s pre-clinical programs
do not advance into the clinic or result in approved products on a
timely or cost effective basis or at all; the cost, timing and results
of clinical trials; that many drug candidates that have completed Phase
1 trials do not become approved drugs on a timely or cost effective
basis or at all; possible safety and efficacy concerns; regulatory
developments; and the ability of Exicure to protect its intellectual
property rights. Exicure’s pipeline programs are in various stages of
pre-clinical and clinical development, and the process by which such
pre-clinical or clinical therapeutic candidates could potentially lead
to an approved therapeutic is long and subject to significant risks and
uncertainties. Risks facing the Company and its programs are set forth
in the Company’s filings with the SEC. Except as required by applicable
law, the Company undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events or


Media Contacts:
MacDougall Biomedical Communications


The Del Mar Consulting Group, Inc.
Robert Prag,

Source: Exicure, Inc.

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