After Curis Inc. (NASDAQ: CRIS) announced preliminary data from its ongoing early-stage study in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS), its shares absolutely exploded higher on Tuesday.

The reported preliminary data are from Curis’s ongoing open-label, single arm Phase 1 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS.

A minimum of three patients will be enrolled in each cohort of the two-part study, starting with 200 mg BID, which was demonstrated to be well-tolerated, capable of achieving relevant levels of drug exposure, and has demonstrated signs of biologic activity in Curis’s ongoing Phase 1 study of CA-4948 for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma.

The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose for CA-4948 based on safety and tolerability, dose-limiting toxicities and any biologic activity, pharmacokinetic and pharmacodynamic findings from the study trial population.

Management noted that it was highly encouraged by the breadth of clinical activity with CA-4948 seen with this early data, especially as this study is both monotherapy and in a late line, relapsed/refractory population. Historically, monotherapy studies in AML and MDS have proven underwhelming, and monotherapy studies in a relapsed/refractory setting have been especially challenging. Overall, the firm is looking forward to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021.

Curis stock traded up 340% to $6.35 Tuesday morning, in 52-week range of $0.62 to $7.13. The consensus price target is $4.75.

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