Moleculin Biotech announces OS data from Phase 1B/2 clinical trial in AML

Moleculin Biotech (MBRX) announced the completion of its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with acute myeloid leukemia. Database lock for the trial is expected by the end of September, with the final clinical study report projected to be published in early Q1 2026. In total, 22 subjects were enrolled in the trial, with all subjects who received AnnAraC per protocol having completed their efficacy evaluations. The updated overall survival data reveal the following: Median OS for Complete Remissions: 15 months with 4 subjects alive at study close; Median OS for the intent to treat Population: 9 months; Median OS for 2L Efficacy Evaluable Population: 12 months. As previously reported, 8 subjects in the ITT population of 22 achieved a complete remission following treatment with AnnAraC. Among the subjects treated in the second line setting, the CR rate, was 50%. Median durability for the 8 subjects achieving a CR was 10 months and continuing at the end of the study. CR durability ranged from 2 months to 22 months. CRs were achieved in subjects with a variety of prior treatments, including traditional 7+3 and venetoclax regimens. The median age of subjects in MB-106 is 68 years. A total of 18 subjects had relapsed/refractory AML and 4 subjects were first line treatment. Two subjects discontinued early due to allergic reactions. All subjects who completed treatment had undergone post therapy disease response assessments. No clinically significant signs of cardiotoxicity were noted during or after treatment in any of the subjects enrolled. The combination was well tolerated with myelosuppression and infections being the main adverse events. All data from MB-106 is preliminary and subject to change. The Company is currently evaluating Annamycin in combination with Cytarabine in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy. This global Phase 3 “MIRACLE” trial includes sites in the US, Europe and the Middle East.