Exicure Reports Activity of AST-008 in Patients with Merkel Cell Carcinoma and Will Enroll Patients in Phase 2 Study
December 11 2019 - 7:00AM
Business Wire
- Phase 1b/2 dose escalation trial of AST-008
shows tolerability of Exicure drug candidate
- Preliminary data show signs of activity in
patients with Merkel cell carcinoma
- Exicure to proceed to Phase 2 study in Merkel
cell carcinoma
Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, today announced an update from its Phase 1b/2 trial
with AST-008 in patients with solid tumors. AST-008 is an
investigational SNA consisting of toll-like receptor 9 (TLR9)
agonists designed for immuno-oncology application, and is being
evaluated in combination with pembrolizumab in patients with solid
tumors.
“We’re very pleased with the preliminary data generated so far
in our ongoing Phase 1b/2 trial and we look forward to enrolling
patients in the Phase 2 portion of the trial,” said Dr. David
Giljohann, CEO of Exicure. “Based on these results, we are
considering adding additional cohorts to the trial in other cancers
where AST-008 may have benefit,” concluded Dr. Giljohann.
The primary objective of the dose escalation portion of the
study is to evaluate the safety, tolerability, pharmacokinetics,
and pharmacodynamics of AST-008 alone and in combination with
pembrolizumab, and to produce a recommended Phase 2 dose. Fourteen
patients have been enrolled and dosed with AST-008. No
treatment-related serious adverse events or dose-limiting
toxicities have been observed. The fifth and final dose escalation
cohort is now open and enrolling.
The study has enrolled five melanoma patients, four Merkel cell
carcinoma (MCC) patients, two cutaneous squamous cell carcinoma
patients, two head and neck squamous cell carcinoma patients, and
one mucosal melanoma patient. Prior to enrolling, most patients had
progressive disease on anti-PD-(L)1 antibodies.
Available data show:
- AST-008 administration, alone or in combination with
pembrolizumab, produced cytokine and chemokine expression and
immune cell activation in patient blood indicative of desired
immune activation.
- Of the 4 MCC patients, one patient, which had previously
progressed on anti-PD-1 antibody therapy, has confirmed stable
disease with decreased target lesion diameters for a period in
excess of twelve weeks, while a second MCC patient experienced a
target lesion complete response and a confirmed overall partial
response longer than 24 weeks.
- Nine patients had progressive disease, two patients have not
yet been evaluated and one is not evaluable.
“The initial results are highly encouraging and warrant
expansion of the trial, and I'm looking forward to participating,”
stated Dr. Steven O’Day, Executive Director of the John Wayne
Cancer Institute and Cancer Clinic, and a principal investigator on
the study.
Detailed results are expected to be presented at major upcoming
oncology meetings. Based on these early results, showing positive
biomarker data and initial tumor responses, Exicure anticipates
enrolling MCC patients, which have previously failed anti
PD-1/PD-L1 therapy, in its Phase 2 study during the first quarter
of 2020.
About Exicure, Inc. Exicure, Inc. is a clinical-stage
biotechnology company developing therapeutics for immuno-oncology,
inflammatory diseases and genetic disorders based on our
proprietary Spherical Nucleic Acid, or SNA technology. Exicure
believes that its proprietary SNA architecture has distinct
chemical and biological properties that may provide advantages over
other nucleic acid therapeutics and may have therapeutic potential
to target diseases not typically addressed with other nucleic acid
therapeutics. Exicure's lead program is in a Phase 1b/2 trial in
patients with advanced solid tumors. Exicure is based outside of
Chicago, IL and in Cambridge, MA.
For more information, visit Exicure’s website at
www.exicuretx.com.
Exicure 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 (including AST-008 and its
potential clinical results), potential studies, 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 or
clinical programs do not advance 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. 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.
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MacDougall Karen Sharma 781-235-3060 ksharma@macbiocom.com
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