Arch Oncology Receives U.S. FDA Orphan Drug Designation for AO-176, a Next-Generation Anti-CD47 IgG2 Antibody, for the Treatment of Multiple Myeloma

BRISBANE, CA and ST. LOUIS, MO, January 21, 2022 – Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 biologic therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to AO-176 on January 3rd, 2022, for the treatment of relapsed/refractory multiple myeloma (r/r MM). AO-176, the Company’s next-generation anti-CD47 antibody, is highly differentiated, with the potential for an improved safety and efficacy profile relative to other agents in this class.

“Multiple myeloma is a type of hematological cancer affecting about 35,000 individuals each year in the US. There is currently no cure for multiple myeloma, and while first-line treatment may result in remission, there remains a significant unmet need for patients with r/r MM,” said Amit Agarwal, M.D., Ph.D., Senior Vice President of Clinical Development at Arch Oncology. “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.”

AO-176 is in Phase 1/2 clinical trials for the treatment of patients with r/r MM, as well as select solid tumors as monotherapy and in combinations with standard of care and is expanding into other malignancies. Additional information about ongoing trials may be found at www.clinicaltrials.gov using the trial identification number NCT04445701 (multiple myeloma) and NCT03834948 (solid tumors).

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About Arch Oncology

Arch Oncology, Inc. is a privately held, clinical-stage immuno-oncology company focused on the discovery and development of potential best-in-class biologic therapies for the treatment of patients with solid tumors and hematologic malignancies. AO-176, the Company’s next-generation anti-CD47 antibody, is highly differentiated, with the potential for an improved safety and efficacy profile relative to other agents in this class. AO-176 is in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and with hematologic malignancies, both as monotherapy and in combination with standard therapies. In addition, the Company is advancing a pipeline of antibody programs for the treatment of cancer. For more information, please visit www.archoncology.com.

Arch Oncology, Inc.
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