Core Insights - Moleculin Biotech, Inc. is collaborating with Atlantic Health to conduct a Phase 1B/2 study of Annamycin for third-line treatment of advanced pancreatic cancer, addressing a significant unmet medical need in this high-mortality disease [1][3][2] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections, with Annamycin as its lead program [11] - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [11][4] Study Details - The Phase 1B/2 study will evaluate Annamycin's efficacy in advanced pancreatic cancer, with an estimated cost of approximately $1 million for the trial from 2026 to 2030 [3][1] - Atlantic Health will conduct the study, while Moleculin will supply Annamycin and manage the Investigational New Drug Application (IND) with the FDA [3][1] Preclinical Data - Recent preclinical studies suggest that Annamycin targets critical factors in pancreatic cancer, showing a high level of activity against the disease and associated liver metastases [2][3] - The upregulation of topoisomerase II, the primary target of Annamycin, correlates with poor survival in pancreatic cancer patients, validating the target's relevance [3][2] Industry Context - Pancreatic cancer is the cancer with the highest mortality rate globally and has limited treatment options, particularly in the third-line setting where no approved standard of care exists [2][3] - The collaboration aims to drive innovation in pancreatic cancer treatment, addressing a significant gap in available therapies for patients who have progressed beyond first- and second-line treatments [3][2]
Moleculin Announces New Investigator-Initiated Study of Annamycin for Treating Pancreatic Cancer