STRO-001 Receives FDA Orphan Drug Designation

Sutro Biopharma has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma. STRO-001 is a potential first-in-class antibody drug conjugate (ADC) targeting CD74, a protein highly expressed in B-cell malignancies such as multiple myeloma.

"There is a growing need for new treatment options for patients with multiple myeloma," said Bill Newell, Sutro's Chief Executive Officer. "This Orphan Drug Designation is a great step towards advancing our uniquely designed STRO-001 that could bring new treatment options to patients in need."

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STRO-001 was developed with Sutro's proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+, which facilitate precision design and rapid empirical optimization of ADCs. Sutro's technology enables design and manufacture of a highly optimized single molecular species within the product, rather than the usual mixture of imprecisely conjugated antibodies that comprise an ADC development product made by conventional cell-based manufacturing platforms.

"STRO-001 was designed to directly target cancer cells to deliver a cytotoxic payload. Building upon our XpressCF+ platform we plan to develop better options to treat tumors with greater precision," Bill Newell said.

STRO-001 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.

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