On May 12, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that two abstracts for CA-4948, a novel, small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress (EHA) (Free EHA Whitepaper), which will be held virtually from June 9-17, 2021 (Press release, Curis, MAY 12, 2021, View Source [SID1234579777]). The abstracts include updated data from a February data-cut for 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).

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"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 (Free EHA Whitepaper) next month."

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
Details of the presentations are as follows:

Oral Presentation:

Title: A Phase 1, Dose Escalation Trial with Novel Oral IRAK4 Inhibitor CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome – Interim Report
Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Session Name: 10. Myelodysplastic syndromes – Clinical
Presentation Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)
Q&A Session: Wednesday, June 16, 2021, 17:00 CEST (11:00 am ET)
Poster Presentation

Title: IRAK4 Inhibitor CA-4948 Potentiates Antitumor Effects of Azacitidine and Venetoclax in Human Acute Myeloid Leukemia
Session Name: 01. Acute lymphoblastic leukemia – Biology & Translational Research
Session Date & Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)
Virtual KOL Event

Virtual event to be hosted Friday, June 11 at 8:00 am ET, featuring Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center
Discussion of the EHA (Free EHA Whitepaper) presentation data from the ongoing Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes
A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.
Additional meeting information can be found on the EHA (Free EHA Whitepaper) website at www.ehaweb.org/congress. Each presentation will also be available under "Events and Presentations" in the Investors section of the Company’s website at www.curis.com

About CA-4948

CA-4948 is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1.