Immusoft Receives FDA Fast Track Designation for ISP-001, a First-in-Class Engineered B Cell Therapy for MPS I
Prospectively designed for scalability and re-dosability, Immusoft’s engineered B cells represent the next generation of advanced therapeutics
SAN FRANCISCO, Oct. 21, 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 Fast Track designation to ISP-001, the Company’s lead investigational therapy for the treatment of mucopolysaccharidosis type I (MPS I), a rare and life-threatening lysosomal storage disorder.
“Receiving Fast Track designation is an important recognition of both the urgent need for new treatment options for MPS I and the groundbreaking potential of our engineered B cell platform,” said Sean Ainsworth, Chief Executive Officer of Immusoft. “In light of our recent successful re-dosing of a patient, receiving Fast Track designation represents a paradigm shift in how genetic diseases can be treated, one that offers the potential for long-term, continuous therapeutic protein delivery that avoids many of the limitations of traditional gene therapy approaches.”
Fast Track is a process designed to facilitate the development and expedite the review of new drugs and biologics intended to treat serious conditions with unmet medical needs. The designation underscores the potential of ISP-001 to transform treatment for patients living with MPS I and represents a significant regulatory milestone for Immusoft and the field of gene and cell therapy.