Core Viewpoint - Moleculin Biotech, Inc. reported positive topline efficacy results from its Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases, indicating significant potential for this treatment option in a challenging cancer market [1][3]. Company Summary - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viruses, with Annamycin as its lead program [13]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for both relapsed or refractory acute myeloid leukemia and soft tissue sarcoma [5]. - The company is also advancing other therapeutic candidates, including WP1066 and WP1122, targeting various cancers and pathogenic viruses [16]. Clinical Trial Results - The MB-107 trial demonstrated a Clinical Benefit Rate (CBR) of 59.4%, with 18 subjects showing stable disease and 1 subject achieving a partial response [6]. - Median Progression Free Survival (PFS) was approximately 4 months, and Overall Survival (OS) was around 20 months for optimized dose subjects [6]. - In Phase 2, subjects with fewer prior therapies (≤2) showed improved OS of 19.9 months and PFS of 127 days, indicating better outcomes with Annamycin [6]. Market Opportunity - The soft tissue sarcoma market is projected to grow to $2.6 billion by 2030, with approximately 13,500 new cases expected annually [1][10]. - The current market for soft tissue sarcoma was valued at $1.58 billion in 2024, with a compound annual growth rate (CAGR) of 8.43% anticipated [10]. Study Design - The MB-107 trial was a multi-center, open-label, single-arm study assessing the safety and efficacy of Annamycin as a monotherapy for STS lung metastases [2][11]. - Treatment involved intravenous infusion of Annamycin over 2 hours, followed by a 20-day rest period, with safety monitoring conducted at each cycle [11][12].
Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107)