Moleculin Biotech reports interim data for Annamycin

Moleculin Biotech announced the presentation of positive interim data for Annamycin from its ongoing acute myeloid leukemia, or AML, clinical development program. As previously announced, the Company will host a virtual AML Clinical Day to discuss these results. “Adding the latest two subjects in MB-106 AML trial with AnnAraC brings the composite complete remission, or CRc, rate up from 37% to 45% for all of the 20 subjects with prior therapies ranging from none to six. This adds to our growing body of positive data which continues to provide a clear line of sight for our clinical and regulatory strategies towards registration for Annamycin in AML,” commented Walter Klemp, Chairman and CEO of Moleculin. “Focusing on 2nd line subjects, a CRc rate of 60% and with 50% of those being full CRs, AnnAraC has the potential to offer 2nd line patients a viable alternative, regardless of prior treatments or mutations. While we believe that the full trial results are impressive, we continue to believe that our results in 2nd line subjects, where there is a significant unmet need, are exceptional and believe the CRc rate demonstrated by AnnAraC in 2nd line patients substantially exceeds the performance reported by any drug currently approved for use in 2nd line AML. The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy. To date, 20 subjects have been enrolled in the full MB-106 Phase 1B/2 study. The median durability of remission is 4.9 months and climbing. DoR is defined as the time from initiation of treatment to the point of disease relapse or death. At the end of January 2024, the Company completed recruiting the desired number of 2nd line subjects and began preparation for an End of Phase 2 meeting with the FDA.