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Curis (CRIS) provides update on data

Curis (CRIS) a bio tech company has announced updated data and acceptance of it’s drug.

  • Updated clinical data from Phase 1/2 study of CA-4948 in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) from February data-cut includes reduction of marrow blasts in 8 out of 9 evaluable patients with elevated blast counts at baseline
  • Four objective responses observed, including 1 complete response (CR), 1 complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and 2 bone marrow CRs
  • All 3 patients with SF3B1 or U2AF1 spliceosome mutation achieved marrow CR or better
  • CA-4948 demonstrated synergistic antileukemic activity in combination with venetoclax and azacitidine in AML cell lines
  • Additional data to be presented in oral presentation and poster session at the European Hematology Association 2021 Virtual Congress (EHA); along with company-hosted virtual KOL event on June 11, 202

Key findings from a cutoff date of February 8, 2021 in 15 patients (8 MDS and 7 AML) include:

  • Bone marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients (at least one malignancy assessment following first cycle) with elevated blast counts at baseline
  • Objective responses observed included 1 patient experiencing a full hematologic recovery complete response, 1 CRi with negative minimal residual disease, and 2 bone marrow CRs
  • All 3 patients with SF3B1 or U2AF1 spliceosome mutation achieved marrow CR or better
  • All patients with objective responses also saw signs of hematologic recovery

“We are very pleased to report this clinical update on our first-in-class IRAK4 kinase inhibitor, CA-4948, as an anticancer agent for patients with acute myeloid leukemia and myelodysplastic syndromes for whom multiple prior lines of therapy have been unsuccessful,” said James Dentzer, President and Chief Executive Officer of Curis. “The clinical data published in the abstract this morning are consistent with our preliminary findings reported late last year showing that CA-4948 has, in addition to encouraging safety characteristics, clear potential to reduce leukemic blasts in late-line patients, along with early signs of hematologic recovery. We look forward to providing updated safety, pharmacodynamic, and efficacy data, as well as data from additional patients and nonclinical combination synergy data at EHA next month.”