Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008)
August 05 2021 - 7:00AM
Business Wire
- Response rate threshold achieved to continue advancing
patient enrollment in Phase 2 Merkel cell carcinoma (MCC)
dose-expansion cohort
- Confirmed overall response rate (ORR) of 21% in all
evaluable MCC patients enrolled in the Phase 1b/2 study
- Median duration of four Phase 1b stage responders is 14
months with the longest response to date of 17 months
Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
technology, is providing an update on the Phase 1b/2 clinical trial
of cavrotolimod (AST-008) (NCT03684785). The Phase 2 stage of the
trial is evaluating cavrotolimod in combination with pembrolizumab
(KEYTRUDA®) or cemiplimab (LIBTAYO®) in patients with locally
advanced or metastatic solid tumors refractory to anti-PD-(L)1
therapy in two primary dose-expansion cohorts, one in MCC and one
in cutaneous squamous cell carcinoma (CSCC), and three exploratory
cohorts.
Interim data highlights from the Phase 2
expansion stage
- As of the data cut-off date of July 1, 2021, 26 patients, all
with documented progression on anti-PD-(L)1 therapy, have been
dosed in the Phase 2 stage, of whom 17 patients were evaluable.
- Nine of the 17 evaluable patients were in the MCC cohort and,
per RECIST v1.1, best overall response was a complete response (CR)
in one MCC patient and stable disease in one MCC patient.
- Injected and non-injected tumor lesions completely resolved in
the MCC patient with a CR, supporting systemic (abscopal)
effects.
- The CR in one MCC patient met the pre-specified Phase 2 stage
threshold to continue advancing patient enrollment in the MCC
dose-expansion cohort.
- The remaining 8 evaluable patients were enrolled in either the
CSCC dose-expansion cohort, in which enrollment and data accrual is
continuing, or in the exploratory cohorts.
- The majority (93%) of treatment-related adverse events (TRAEs)
were grade 1 or grade 2. The most common TRAEs were injection-site
reactions and flu-like symptoms.
- Two patients experienced serious adverse events assessed as
related to cavrotolimod by clinical trial investigators.
Treatment-related hypotension and flu-like symptoms were reported
in one melanoma patient and a treatment-related injection reaction
was reported in one MCC patient.
The confirmed ORR in all evaluable MCC patients enrolled in
total in the Phase 1b/2 trial was 21% (three of 14) as of the July
1, 2021 data cutoff date.
- The three patients were comprised of two CRs and one partial
response (PR).
- Biopsy of individual tumor lesions of the MCC patient assessed
as PR by RECIST v1.1 revealed no evidence of residual tumor.
As of August 4, 2021, total trial enrollment for the Phase 1b/2
trial including primary and exploratory cohorts was 51
patients.
“Merkel cell carcinoma is an aggressive skin cancer with a high
probability of metastasis. Observing a patient with metastatic MCC
who had been previously progressing on pembrolizumab monotherapy
and radiation, achieve a complete response, is highly encouraging,”
said Dr. Sunandana Chandra, M.D., Assistant Professor at
Northwestern University Feinberg School of Medicine and principal
investigator in the Phase 1b/2 clinical trial of cavrotolimod.
Trial results and further response details are summarized in the
company's updated corporate presentation on the Company’s
website.
About Cavrotolimod (AST-008)
Cavrotolimod (AST-008) is an SNA consisting of toll-like
receptor 9 agonists designed for immuno-oncology applications.
Cavrotolimod is in a Phase 1b/2 clinical trial in patients with
advanced solid tumors. 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 cancer patients. In the second
quarter of 2020, Exicure initiated the Phase 2 stage of the
clinical trial with dose-expansion cohorts of intratumoral
cavrotolimod in combination with approved checkpoint inhibitors to
treat two cohorts of patients with locally advanced or metastatic
MCC or CSCC. Additional information regarding the Phase 1b/2 study
can be found here: https://clinicaltrials.gov/ct2/show/NCT03684785.
Cavrotolimod in combination with anti-PD-1 therapy was granted Fast
Track and Orphan Drug designations for locally advanced or
metastatic MCC refractory to anti-PD-(L)1 therapy and Fast Track
designation for locally advanced or metastatic CSCC refractory to
anti-PD-1 therapy.
About Exicure, Inc.
Exicure, Inc. is a clinical-stage biotechnology company
developing therapeutics for neurology, immuno-oncology,
inflammatory diseases and other genetic disorders based on its
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 intrathecal treatment of
Friedreich’s ataxia (FA). Exicure's therapeutic candidate
cavrotolimod (AST-008) is in a Phase 1b/2 clinical trial in
patients with advanced solid tumors. Exicure is based in Chicago,
IL and 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 design, timing and results of
the Company’s Phase 1b/2 clinical trial of cavrotolimod (AST-008)
including patient enrollment expectations; the company’s business
strategy regarding cavrotolimod; and the potential of cavrotolimod
to provide therapeutic benefit to patients with Merkel cell
carcinoma (MCC) and cutaneous squamous cell carcinoma (CSCC).
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 it has to date or more severely than
anticipated, which may have the effect of impacting or delaying the
company’s ongoing Phase 1b/2 clinical trial of cavrotolimod;
unexpected costs, charges or expenses that reduce the company’s
capital resources; the company’s preclinical or clinical programs
do not advance or result in approved products on a timely or cost
effective basis or at all; the results of early clinical trials are
not always being predictive of future results; the cost, timing and
results of clinical trials; that many drug candidates 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 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 Annual Report on
Form 10-K for the year ended December 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:
MacDougall Karen Sharma 781-235-3060 ksharma@macbiocom.com
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