Curis Inc (NASDAQ: CRIS) shares are surging in reaction to updated data from its ongoing open-label, single-arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
As of data cut off on February 8, in 15 patients (8 MDS and 7 AML), four objective responses were recorded with signs of hematologic recovery, including:
One complete response (CR), one complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and two bone marrow CRs.
All three patients with SF3B1 or U2AF1 spliceosome mutation achieved marrow CR or better.
The company said that two abstracts with updated data would be presented at the upcoming European Hematology Association 2021 Virtual Congress to be held next month.
CA-4948 is an IRAK4 kinase inhibitor, and IRAK4 plays an essential role in the toll-like receptor and interleukin-1 receptor signaling pathways, which are frequently dysregulated in patients with AML and MDS.
Cantor Fitzgerald analyst Alethia Young views Curis's abstract update as highly encouraging with more patients and longer follow-up, the analyst tells investors in a research note.
The analyst made no changes to the firm's Overweight ratings and thinks the initial look from the abstracts appears very positive.
Last month, CA-4948 received FDA's Orphan Drug designation in AML and MDS.
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