Immusoft Announces FDA Clearance of IND Application for ISP-001 for MPS I, the First Engineered B Cell Therapy to Enter into Clinical Trials

Immusoft, a clinical-stage cell therapy company dedicated to improving the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for ISP-001 in the treatment of MPS I. The open IND enables Immusoft to initiate a Phase 1 clinical study. This milestone is both significant for Immusoft and historic in the field of cell and gene therapies, as ISP-001 will be the first engineered B cell therapy to enter into human clinical trials. Immusoft has pioneered the engineering of B cells to create biofactories for in vivo therapeutic protein delivery, leading the field with over 60 issued and pending patents. Read more >>