Curis Inc. (NASDAQ: CRIS) has announced positive updated clinical results from its ongoing open-label Phase 1/2 dose expansion and escalation study of CA-4948, a proprietary small molecule IRAK-4 inhibitor, a single agent in patients with refractory/relapsed acute myeloid leukemic or high-risk myelodysplastic syndromes. In addition, the company also announced interims safety, pharmacodynamics, and pharmacokinetic data from the first phase dose-escalation study of CI-8993, a VISTA targeting monoclonal antibody for the treatment of r/r solid tumor patients.
CA-4948 demonstrated potential as monotherapy in r/r AML/MDS
CEO James Dentzer said, “These data continue to build on what we believe to be a compelling profile for CA-4948, showing its activity as a monotherapy in a targeted population of patients living with R/R AML/MDS, for whom prior lines of therapy have been unsuccessful. We are especially pleased that these results demonstrate both a favorable safety profile and improved anti-cancer activity compared with standard of care therapies for these patients. Furthermore, we have been able to successfully identify and enroll these patients using existing genetic diagnostic panels. We remain on track to enroll additional patients with a spliceosome mutation to prepare for potential discussions with the US Food and Drug Administration (FDA) in the first half of 2022 regarding the potential for a rapid registrational path forward for CA-4948 as monotherapy in genetically-defined patient populations.”
CA-4948 demonstrated favorable safety profiles across dose levels
Dentzer continued, “We are also encouraged by the safety data from the CI-8993 trial, which we believe demonstrate that the procedures we implemented to manage the expected cytokine release effect have been successful – and have allowed us to escalate patient dosing up to and beyond 0.3 mg/kg. We have recently begun dosing at 0.6 mg/kg; and look forward to providing another update on our progress in the second half of 2022.”
As of December 16, 2021, the company had dosed 49 patients with CA-4948 in the r/r AML/MDA trial across 500mg, 400mg, 300mg, and 200mg dose cohorts. CA-4938 demonstrated a favorable safety profile across dose levels with manageable and reversible adverse events.