Company Overview - Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [6] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at avoiding multidrug resistance and cardiotoxicity associated with current treatments [6] Clinical Trials and Results - The company has completed its End of Phase 2 (EOP2) meeting with the FDA regarding the Phase 1B/2 clinical trial of Annamycin in combination with Cytarabine for treating acute myeloid leukemia (AML) [8] - In the ongoing MB-106 clinical trial, 22 subjects have been enrolled, with 20 completing efficacy evaluations; 9 subjects (45%) achieved a composite complete remission (CRc) [12] - Among the 10 subjects treated with AnnAraC in the second-line setting, 5 achieved a complete remission (CR) [1] Drug Development Pipeline - The company is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and other cancers [2] - Moleculin is working on a portfolio of antimetabolites, including WP1122, for potential treatment of viruses and certain cancer indications [2] Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation from the European Medicines Agency [9]
Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML