SKOKIE, Ill.--(BUSINESS WIRE)--Feb. 25, 2019--
Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, announced today that it has dosed the first patient in its
multicenter, open-label, Phase 1b/2 study of AST-008 combined with
pembrolizumab. Enrollment in the trial is open to patients with
superficial injectable tumors in advanced or metastatic solid tumor
conditions including Merkel cell carcinoma, head and neck squamous cell
carcinoma, cutaneous squamous cell carcinoma and melanoma. clinicaltrials.gov
NCT03684785
“We believe that combining our immune system agonist drug with
checkpoint inhibitors is an important strategy for leveraging the
patient’s own immune system to fight cancer. We are excited to bring
this approach into cancers like Merkel cell carcinoma, where patients
have limited success using currently available treatments,” said Exicure
CEO Dr. David Giljohann. “It is also an important milestone for Exicure
in the development of our platform technology, which allows us to
digitally design drug candidates and potentially bring them into clinic
faster.”
The primary objective of the Phase 1b dose escalation stage is to assess
the safety and tolerability of Exicure’s AST-008 drug alone and in
combination with pembrolizumab, and to determine a dose for the Phase 2
stage of the study. Patients in the dose escalation stage may have
previously been exposed to antibody checkpoint inhibitors, but not as a
requirement for inclusion in the trial. In the Phase 2 portion of the
study, Exicure will further evaluate AST-008 in combination with
pembrolizumab in patients who have previously received but not responded
to anti-PD-1 or anti-PD-L1 antibody therapy.
About Exicure’s AST-008 Drug
AST-008 is a toll-like receptor nine (TLR9) agonist oligonucleotide in a
proprietary SNA format with immune-stimulatory properties. SNAs are
dense, radial arrangements of nucleic acids (DNA) that have high
cellular uptake and an enhanced presentation of the DNA for TLR9
agonism. AST-008 is designed to enter into and activate immune cells to
elicit an immune response to treat solid tumors in combination with
other agents such as checkpoint inhibitors. We observed that AST-008
showed potent antitumor activity as a monotherapy and synergized with
anti-PD-1 antibodies in multiple preclinical tumor models. In a
successful Phase 1 trial in healthy volunteers, AST-008 activated key
immune cells and cytokines predictive for an anti-tumor effect in
patients.
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 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
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; the ability to enroll patients in clinical trials;
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 otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190225005279/en/
Source: Exicure, Inc.
Media Contacts:
MacDougall Biomedical Communications
Karen
Sharma
781-235-3060
ksharma@macbiocom.com