Curis Inc. (NASDAQ: CRIS) Doses First Subject in The Combination Therapy Study of CA-4948 in AML and MDS

Curis Inc. (NASDAQ: CRIS) has announced the dosing of the first patient in the combination therapy part of the Phase 1/2 clinical trial evaluating CA-4948 in high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). CA-4948 is a proprietary small molecule IRAK4 kinase inhibitor.

Curis delighted to commence its phase 1 CA-4948 study 

CEO of Curis James Dentzer, “We are very pleased to announce the initiation of our Phase 1 combination therapy study of CA-4948, which is an important part of our development strategy to address the broader AML/MDS patient population. This comes on the heels of the promising initial monotherapy data with CA-4948 in this patient population. Armed with these results and combined with preclinical data highlighting CA-4948’s synergistic antitumor activity when used in combination with azacitidine and venetoclax, and the absence of overlapping dose-limiting toxicity, we are hopeful that this combination portion of the trial will allow us to advance CA-4948 as a promising new treatment for an additional population of patients with AML/MDS.”

Nebraska Cancer Specialists oncologist and hematologists and Lead study investigator Stefano Tarantolo said Based on CA-4948’s initial efficacy and tolerability in monotherapy, we are looking forward to exploring safety and efficacy for CA-4948 in combination with azacitidine or venetoclax. We are hopeful that CA-4948 may offer an important new treatment option, as many of these patients are ineligible for intensive chemotherapy and face an extremely poor prognosis.”

Dose escalation and expansion monotherapy combination added to study 

A monotherapy combination dose-escalation and expansion were added to the Phase 1/2 study. Both R/R MDS patients with and without a spliceosome alteration and R/R AML patients with and without an FLT3 mutation were included in the monotherapy component of the trial. The study’s combination therapy arm has two arms: CA-4948 and azacitidine for patients who have never had HMA, and CA-4948 combination with venetoclax for those who have never had venetoclax.

The study’s primary goal was to establish the recommended phase 2 CA-4948 dose to be used in combination with venetoclax and azacitidine.