Exicure Shares Interim Cavrotolimod Data From Early-Stage Trial In Solid Tumor Patients

Exicure Inc XCUR has reported interim results from Phase 1b/2 trial evaluating cavrotolimod (AST-008) in patients with advanced or metastatic solid tumors refractory to anti-PD-(L)1 therapy.
The trial is assessing cavrotolimod in combination with Merck & Co Inc's MRK Keytruda (pembrolizumab) or Sanofi SA SNY - Regeneron Pharmaceuticals Inc's REGN Libtayo (cemiplimab) in two primary dose-expansion cohorts, one in Merkel cell carcinoma (MCC) and one in cutaneous squamous cell carcinoma (CSCC), and three exploratory cohorts.

As of the data cutoff date of July 1, 26 patients were dosed, of whom 17 were evaluable.

One MCC patient achieved Complete response (CR), and one MCC patient achieved stable disease.

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 mild or moderate. 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.

The confirmed overall response rate (ORR) in all evaluable MCC patients was 21% (three of 14), included two CRs and one partial response (PR).

Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications.

Price Action: XCUR shares are down 4.61% at $1.35 during the market session on the last check Thursday.

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