Exicure to Present at the American Society of Clinical Oncology 2020
May 14 2020 - 7:00AM
Business Wire
Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, will present a poster at the 2020 Annual Meeting of the
American Society of Clinical Oncology (ASCO), taking place
virtually from May 29-31.
The ASCO poster, by Dr. Mohammed Milhem of the University of
Iowa and coauthors, titled “AST-008: A Novel Approach to TLR9
Agonism with PD-1 Blockade for Anti-PD-1 Refractory Merkel Cell
Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (CSCC)” will
be presented virtually in the Developmental
Therapeutics—Immunotherapy Poster Session under abstract number
TPS3164.
The poster will present details of the phase Ib/II trial of
Exicure’s drug candidate, AST-008, a toll-like receptor 9 agonist
oligonucleotide being developed for the treatment of MCC and CSCC
in patients progressing on immune checkpoint inhibitor
monotherapy.
Key features of the phase Ib/II trial described in the poster
include:
- Advanced/metastatic MCC and CSCC are skin cancers with high
unmet medical need;
- Data presented earlier suggest that AST-008 elicits a Th1-type
cytokine response and immune cell activation;
- The phase II dose escalation study will use the recommended
dose of AST-008, administered intratumorally, in combination with
pembrolizumab or cemiplimab to treat two cohorts of patients with
advanced/metastatic MCC or CSCC respectively;
- The enablement of a dose expansion of AST-008 plus cemiplimab
in CSCC without having performed a separate dose escalation with
the latter combination;
- Each expansion cohort will enroll up to 29 patients across
about 15 US-based sites;
- Patients enrolled into the phase II will have to have
progressed on a single-agent checkpoint therapy;
- The key objective of the phase II expansion is to provide an
estimate of preliminary efficacy of intratumorally administered AST
in the trial subjects. Other endpoints include safety,
pharmacokinetic and pharmacodynamic assessments.
About AST-008
AST-008 is an SNA consisting of toll-like receptor 9 agonists
designed for immuno-oncology applications. As of January 31, 2020,
we have dosed 17 patients in the Phase 1b stage of the clinical
trial. We have observed no treatment related serious adverse
events, nor have we observed any dose-limiting toxicity among the
treated subjects. The most common reported adverse event was
injection site reactions. In December 2019, we received preliminary
results from the Phase 1b/2 stage of the clinical trial showing
potential signs of anti-tumor activity in patients with Merkel cell
carcinoma. In the second quarter of 2020, we plan to initiate a
Phase 2 dose expansion for intratumoral AST-008 in combination with
approved checkpoint inhibitors to treat two cohorts of patients
with advanced or metastatic Merkel cell carcinoma or cutaneous
squamous cell carcinoma. Each cohort is expected to enroll up to 29
patients who have failed anti-PD-1/PD-L1, or programmed cell death
protein 1/programmed death-ligand 1, therapy. We expect to open a
total of up to 15 sites in the United States.
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.
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Karen Sharma MacDougall 781-235-3060 ksharma@macbiocom.com
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