Moleculin Biotech announces interim data on MB-106

Moleculin Biotech provided a preliminary update on recent clinical activity and expected near term milestones for its lead program MB-106 for the treatment of Acute Myeloid Leukemia following its Fiscal Year 2023 filing with the Securities and Exchange Commission. The total CRs in both Phases to date in MB-106 represent a complete response composite rate of 39% in all currently evaluable, intent to treat subjects with two additional subjects recruited not yet evaluable. These subjects had 0-6 prior therapies. This is comprised of a CR rate of 33% and CRi of 6%. Durability data are developing with one CRc having relapsed to date. The first CR subject was treated in February 2023 and remains durable after over a year and continues in remission. Durability of CRs is confirmed by repeat bone marrow aspirates. The median age of all subjects recruited is 69, ranging from 19 to 78. Median durability will be established as the trial data mature. This trial may enroll up to 28 subjects, however, having already recruited the desired number of 2nd line subjects to support an EoP2 meeting with the FDA, the Company may elect to complete this trial with fewer than 28 subjects.