Moleculin Biotech reports data from Phase 1B/2 (MB-106) clinical trial

Moleculin Biotech reported additional efficacy findings from the company’s ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with acute myeloid leukemia. The preliminary data was presented at the European Hematology Association 2024 Hybrid Congress. The company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA 2024 Congress. To date, a total of 22 subjects have been enrolled, 20 of whom have completed efficacy evaluations with 9 subjects achieving a composite complete remission, consisting of 8 subjects with complete remission and one subject with complete remission with an incomplete recovery of peripheral blood counts, following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects are pending. Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 6 months and climbing. Additionally, the median overall survival in the 2nd line subjects is approximately 6 months and increasing. Additionally, 89% of the subjects included in the CRc group had cytogenetics and/or mutations generally considered to contribute to a poor prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet statistically relevant, the company believes such cytogenetic and mutation data are informative to clinicians. “We continue to be highly encouraged by the positive growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML,” commented Walter Klemp, Chairman and CEO of Moleculin. “While still preliminary, we believe the efficacy to date including the climbing durability of response demonstrated by AnnAraC in 2nd line patients continues to significantly exceed the performance reported by any drug currently approved for use in 2nd line AML. We are incredibly pleased with the progress of the trial and the data and continue to advance our preparations for an End of Phase 2 meeting with FDA.”