Benzinga | Jan 6, 2022 07:07AM EST

Curis Announces Updated Data With Additional Encouraging Clinical Activity In Phase 1/2 Study Of CA-4948 Monotherapy In Targeted Patients With Relapsed Or Refractory AML And MDS

Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive updated clinical data from the ongoing open label Phase 1/2 dose escalation and expansion study of CA-4948, a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (MDS) as well as initial safety, pharmacokinetic and pharmacodynamic data from the Phase 1 dose escalation study of CI-8993, a monoclonal antibody targeting VISTA for patients with R/R solid tumors.

"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," said James Dentzer, President and Chief Executive Officer of Curis. "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 U.S. Food and Drug Administration (FDA) in the first half of 2022 regarding the potential for a rapid registrational path forward for CA-4948 as a monotherapy in genetically-defined patient populations."

"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," he continued. "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. We are thrilled to have achieved this key safety and dose escalation milestone, as it brings us one step closer to providing anti-VISTA therapy for patients living with solid tumors."