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# Arch Oncology Orphan Status for Multiple Myeloma
- URL: https://www.fdaweb.com/arch-oncology-orphan-status-for-multiple-myeloma/
- Published: 2022-01-21T12:00:00.000Z
- Updated: 2026-09-14T17:29:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150979

FDA has granted Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma (r/r MM). AO-176 is in Phase 1/2 clinical trials for treating patients with r/r MM, as well as select solid tumors as monotherapy and in combinations with standard of care.

The company says AO-176, its next-generation anti-CD47 antibody, is highly differentiated and has the potential to provide an improved safety and efficacy profile relative to other agents in this class. “We believe the multiple unique properties of AO-176, including lower binding to normal cells and negligible binding to red blood cells, enhanced binding to CD47 in acidic environments found in tumors, and induction of programmed and immunogenic cell death, in addition to strong preclinical data in multiple myeloma, could make AO-176 a promising new first-in-class therapeutic approach to improving outcomes for these patients,” it says.