Moleculin Biotech’s WP1122 Receives Fast Track Status for Glioblastoma
Moleculin Biotech’s WP1122 has gained Fast Track status from the FDA for the treatment of glioblastoma multiforme, an aggressive cancer that occurs in the brain or spine.
WP1122 is a patented prodrug — an inactive compound that is metabolized in the body to produce a drug — that directs cells to pull in glucose from the blood.
In preclinical studies, WP1122 outperformed the standard of care in mice who were transplanted with human brain tumors, the company said.
WP1122 previously gained Orphan Drug status and FDA clearance for an Investigational New Drug application to begin a phase 1 clinical trial.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of highly resistant tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.
December 13, 2022
