Investigational Therapy for Myeloma, STRO-001, Granted Orphan Drug Designation by FDA
Posted: Thursday, October 25, 2018
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to Sutro Biopharma’s STRO-001 in the treatment of multiple myeloma. STRO-001 is a potential first-in-class antibody-drug conjugate targeting CD74, the protein expressed in B-cell malignancies such as multiple myeloma.
STRO-001 was developed with the cell-free protein synthesis and site-specific conjugation platform, XpressCF+™, which facilitate design and empirical optimization of antibody-drug conjugates. Such technology enables the design and manufacture of an optimized single molecular species within the product, rather than the usual mixture of conjugated antibodies that comprise an antibody-drug conjugate development product made by conventional cell-based manufacturing platforms.
STRO-001 is currently being studied in a phase I clinical trial (ClinicalTrials.gov identifier NCT03424603). This trial is enrolling separate dose-escalation cohorts for both myeloma and B-cell lymphoma. In this study, which is currently recruiting at seven sites in the United States, investigators plan to recruit 220 patients.
