Exicure Presents Cavrotolimod (AST-008) Clinical Data at AACR 2020 Virtual Meeting
June 22 2020 - 7:00AM
Business Wire
Poster presentation of pharmacodynamic and safety data of
cavrotolimod (AST-008) from Exicure’s ongoing Phase 1b/2 clinical
trial in solid tumor patients
Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, is presenting updated pharmacodynamic and safety data
at the American Association of Cancer Research (AACR) Virtual
Annual Meeting II, occurring June 22 – 24, 2020.
The AACR poster, titled “Phase 1b/2 Study of an Intratumoral
TLR9 Agonist Spherical Nucleic Acid (AST-008) and Pembrolizumab:
Evidence of Immune Activation,” is presenting new preliminary
pharmacodynamic and safety data of cavrotolimod (AST-008), alone
and in combination with pembrolizumab, from Exicure’s ongoing Phase
1b/2 clinical trial (ClinicalTrials.gov identifier: NCT03684785).
Cavrotolimod (AST-008) is a novel SNA configuration of a toll-like
receptor 9 (TLR9) agonist oligonucleotide, designed to trigger
anti-tumor immune responses.
Gene expression analysis data from patient tumor biopsies
demonstrated increases in leukocytes in injected tumors after
intratumoral (IT) cavrotolimod (AST-008) alone and in combination
with pembrolizumab versus baseline. Uninjected tumors also showed
increased immune cell levels after patients received cavrotolimod
(AST-008) and pembrolizumab, suggesting immune cell
trafficking.
Dose-dependent activation of key immune cells, including
cytotoxic T cells and natural killer cells, as well as increases in
cytokine/chemokine levels were observed in patient blood after IT
cavrotolimod (AST-008) treatment alone, and cavrotolimod (AST-008)
plus pembrolizumab treatment. We expect that activation of these
cell types and expression of immune system signaling proteins may
help produce anti-tumor effects.
Cavrotolimod (AST-008) was well-tolerated, with a safety profile
consisting primarily of injection site reactions and flu-like
symptoms, which is believed to reflect local and systemic immune
activation. No cavrotolimod (AST-008)-related serious adverse
events or dose limiting toxicity have been reported.
Using these data, a recommended Phase 2 dose of 32 mg
cavrotolimod (AST-008) has been identified for the Phase 2 portion
of the clinical trial now underway, where cavrotolimod (AST-008)
will be given in combination with pembrolizumab or cemiplimab for
the treatment of locally advanced or metastatic Merkel cell
carcinoma or cutaneous squamous cell carcinoma, respectively, in
patients with progression despite approved anti-PD-(L)1
therapy.
This poster is being presented during the AACR Virtual Meeting
II in the session Late-Breaking Research: Clinical Research 1 /
Endocrinology under abstract number LB-140. The poster will be
available for viewing from June 22 – 24.
About Exicure, Inc. Exicure, Inc. is a clinical-stage
biotechnology company developing therapeutics for neurology,
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 is in preclinical development of XCUR-FXN, an
SNA–based therapeutic candidate for the treatment of Friedreich’s
ataxia (FA). Exicure's drug candidate cavrotolimod (AST-008) is
currently in a Phase 1b/2 clinical trial in patients with Merkel
cell carcinoma or cutaneous squamous cell carcinoma in the
advanced/metastatic stage. Exicure is based in Chicago, IL and also
has an office in Cambridge, MA. For more information, visit
Exicure’s website at www.exicuretx.com.
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements in this
press release other than statements of historical fact could be
deemed forward looking including, but not limited to, the company’s
expectations regarding potential benefits, of cavrotolimod
(AST-008), including the ability of cavrotolimod (AST-008) to
trigger anti-tumor immune responses, and the safety and
tolerability of cavrotolimod (AST-008). The forward-looking
statements in this press release speak only as of the date of this
press release, and the company undertakes no obligation to update
these forward-looking statements. Forward-looking statements are
based on management’s 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: the risks that the ongoing
COVID-19 pandemic may disrupt the company’s business and/or the
global healthcare system more severely than anticipated; the cost,
timing and results of clinical trials; the ability to enroll and
maintain patients in clinical trials; and possible safety and
efficacy concerns. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause the company’s actual results to differ from those contained
in the forward-looking statements, see the section titled “Risk
Factors” in the company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2020, as updated by the company’s
subsequent filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release,
and the company undertakes no duty to update this information,
except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200622005190/en/
Media Contact Karen Sharma MacDougall 781-235-3060
ksharma@macbiocom.com
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