Business
Moleculin Announces Positive Interim Data in Annamycin Clinical Trials: MB-106 AML Trial Complete Response (CR) Rate of 38% and MB-107 STS Lung Mets Trial Median Phase 1B Extended Overall Survival of 11 Months
– MB-106: CR rate of 38% (N=8) with durability up to 8 months – Builds on CRi rate of 60% in MB-105 monotherapy AML trial last cohort (N=5) – MB-107: Phase 1B
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– MB-106: CR rate of 38% (N=8) with durability up to 8 months\n– Builds on CRi rate of 60% in MB-105 monotherapy AML trial last cohort (N=5)\n– MB-107: Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15)\n– MB-107 Phase 1B/2 median progression free survival (PFS) of 3.4 months for subjects dosed at or below 330 mg/m2 and less than 3 prior therapies (N=9)\n– 100% of Annamycin subjects in multiple studies (N=66) continue to show no signs of cardiotoxicity during study\nHOUSTON, Nov. 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today provided a preliminary update on recent clinical activity and expected near term milestones across its clinical development pipeline in its quarterly filing with the Securities and Exchange Commission.\n\n \n \n \n \n \n \n\n \n\"Despite a host of recent new drug approvals, the most important therapeutic tool for treating AML and advanced STS continues to be an anthracycline. We believe the data we are now showing in Annamycin's clinical trials on those indications are demonstrating a potential to finally bring an anthracycline to the table for those patients who have until now been prevented from using them,\" Walter Klemp, Chairman and Chief Executive Officer of Moleculin stated. \"Importantly, as we continue to show zero cardiotoxicity in 100% of subjects in multiple studies, Annamycin is now also showing substantial activity in Phase 2 studies across two indications.\"\n\"Having 38% of subjects with a median age of 68 in our MB-106 AML study receiving a full course of Annamycin show a complete response with durability of up to approximately 8 months and counting, we believe, is exceptional while also demonstrating no cardiotoxicity,\" Dr. Paul Waymack, Senior Chief Medical Officer said. \"Adding to this, we are showing in our Phase 1B/2 study with Annamycin treating soft tissue sarcoma (STS) with pulmonary metastases for subjects with no limit on prior therapies (median of 3; range of 1-11) PFS of 2.2 months or better for 59% of the subjects (N=32). In subjects with fewer prior therapies (prior therapies","length":3760,"tagName":"div"}]