Exicure Announces First Patient Dosed in Phase 2 Merkel Cell Carcinoma Trial of Cavrotolimod (AST-008)
June 16 2020 - 7:00AM
Business Wire
Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, announced today the dosing of the first patient
enrolled in the Phase 2 dose expansion stage of the cavrotolimod
(AST-008) Phase 1b/2 clinical trial (ClinicalTrials.gov identifier:
NCT03684785).
“We believe this milestone marks an important step toward
fulfilling an unmet treatment need for Merkel cell carcinoma
patients who have been resistant to checkpoint inhibitor antibody
therapy,” said Dr. Douglas Feltner, Chief Medical Officer of
Exicure.
The Phase 2 dose expansion stage includes two cohorts of
patients with advanced or metastatic cancer: patients with Merkel
cell carcinoma (MCC) and patients with cutaneous squamous cell
carcinoma (CSCC). MCC is a rare, aggressive skin cancer considered
more deadly than melanoma. Risk factors for MCC include sun
exposure and a weakened immune system. Advanced or metastatic CSCC
is an uncommon form of skin cancer associated with significant
morbidity and mortality.
The dose expansion stage is designed to assess the anti-tumor
response rate of cavrotolimod plus checkpoint inhibitor treatment,
the safety and tolerability of the combination, and drug
pharmacodynamics and pharmacokinetics. Patients enrolled in the
dose expansion cohorts must have recently documented tumor
progression despite anti-PD-1 or anti-PD-L1 antibody
monotherapy.
About Cavrotolimod (AST-008)
Cavrotolimod (AST-008) is an SNA consisting of toll-like
receptor 9 agonists designed for immuno-oncology applications. In
December 2019, Exicure announced preliminary results from the Phase
1b stage of the clinical trial including potential signs of
anti-tumor activity with cavrotolimod in combination with
pembrolizumab in patients with MCC. To date, 20 patients in the
Phase 1b stage of the clinical trial have been dosed, and no
cavrotolimod-related serious adverse event or dose-limiting
toxicity has been reported. The most commonly reported adverse
events were injection site reactions and flu-like symptoms. In the
second quarter of 2020, Exicure initiated Phase 2 dose expansion
cohorts of intratumoral cavrotolimod in combination with approved
checkpoint inhibitors to treat two cohorts of patients with
advanced or metastatic MCC or CSCC. Each cohort is expected to
enroll up to 29 patients whose tumors have progressed on
anti-PD-1/PD-L1, or programmed cell death protein 1/programmed
death-ligand 1, antibody monotherapy.
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 AST-008 is currently in a
Phase 1b/2 clinical trial in patients with advanced solid tumors.
Exicure is based outside of 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, statements regarding the conduct of the company’s
ongoing Phase 1b/2 clinical trial for cavrotolimod (AST-008),
including its expectations regarding timing and dosage of patients
and the anticipated size of the cohorts in the Phase 2 dose
expansion stage of the Phase 1b/2 clinical trial; and the company’s
expectations regarding potential benefits, safety and tolerability
of cavrotolimod (AST-008), including the potential of cavrotolimod
(AST-008) as a treatment for patients with Merkel cell carcinoma.
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 the
company’s clinical trials; the ability to enroll and maintain
patients in its clinical trials; possible safety and efficacy
concerns; regulatory and competitive landscape developments; and
the ability of the company to protect its intellectual property
rights. 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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Media Karen Sharma MacDougall 781-235-3060
ksharma@macbiocom.com
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