This Curis Cancer Study Is a Big Hit

Curis has announced preliminary data from its ongoing early-stage study in patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

Published December 8, 2020, 9:56am ET · 2 min read

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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.

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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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Chris Lange

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics. Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications. A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.

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