Curis, Inc. CRIS shares were skyrocketing Tuesday on above-average volume after the company announced updated Phase 1 data on its investigational asset CA-4948 in treating acute myeloid leukemia and myelodysplastic syndromes.
What Happened: As of Nov. 23, four AML and three high-risk MDS patients were enrolled in the first two study cohorts of the Phase 1 study that evaluated CA-4948, a small-molecule IRAK4 kinase inhibitor, the company said, citing preliminary data.
No dose-limiting toxicities were observed in the 200mg and 300mg, twice-a-day cohorts, according to Lexington, Massachusetts-based Curis.
All six evaluable patients showed marrow blast reductions, and two patients experienced a marrow complete response, the company said.
The company also said enrollment has started in the 400mg, twice-a-day arm.
"We are 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," CEO James Dentzer said in a statement.
Why It's Important: Curis shares came under pressure Monday and shed about 24% after it presented at the ASH with not-so-impressive early stage results for the same investigational treatment option in non-Hodgkin's lymphoma.
The sell-side, however, viewed the data as positive.
"We note that the NHL ASH data is in-line with what was previously revealed, so we were surprised to see the stock down over 23% following the announcement. We believe the reported biomarker data bode well for patient selection," H.C. Wainwright analyst Edward White said in a note.
What's Next: Curis said it is comfortable with pace at which its trial partners have been able to enroll patients.
The company said it looks ahead to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021.
CRIS Price Action: Curis shares were rallying by 364.58% to $6.69 at last check Tuesday.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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