Orphan Drug Designation for MPS II builds on Immusoft’s clinical progress in MPS I and supports expansion of its engineered B cell platform across multiple indications SAN FRANCISCO, Dec. 15, 2025 /PRNewswire/ — Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ISP-002, the Company’s investigational engineered B cell therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, a rare and life-threatening lysosomal storage disorder. MPS II is caused by a deficiency of the enzyme iduronate-2-sulfatase (IDS), which leads to the progressive accumulation of glycosaminoglycans throughout the body. The disease results in multi-system pathology, including skeletal abnormalities,
