Cullinan Oncology(US:CGEM) Globenewswire·2025-11-03 14:11Core Insights - CLN-049 has shown promising anti-leukemic activity in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), achieving a composite complete response (CRc) rate of approximately 30% at clinically active doses [1][11] - The drug demonstrated a manageable safety profile across all assessed doses, with the most common treatment-emergent adverse events being cytokine release syndrome (40%) and infusion-related reactions (35%) [12][7] - Cullinan Therapeutics plans to present updated clinical data at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025 [1][3] Company Overview - Cullinan Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing first- or best-in-class therapies for autoimmune diseases and cancer [15] - The company is advancing its pipeline with a focus on T cell engagers, which are established in oncology and are now being explored for autoimmune diseases [15] Clinical Study Details - The Phase 1 study of CLN-049 enrolled 40 patients (34 with AML and 6 with MDS) and assessed safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy [10][4] - The study included patients who had received a median of 2 prior therapies, indicating a heavily pretreated population [4] Efficacy Results - At the highest target dose of 12 μg/kg, the CRc rate was 31% and the overall response rate (ORR) was 69% [11] - Responses were observed in patients with AML regardless of baseline genetic risk, including those with TP53 mutations, where 4 out of 5 patients showed responses [11][2] Safety Profile - The safety profile of CLN-049 was deemed manageable, with no treatment discontinuations due to adverse events [12][7] - Grade ≥3 treatment-emergent adverse events included febrile neutropenia and white blood cell count decrease, each occurring in 17.5% of patients [12]