The re-dose of ISP-001 has been well-tolerated, to date, and Immusoft continues to observe positive results SAN FRANCISCO, Oct. 7, 2025 /PRNewswire/ — Immusoft of CA, a clinical stage, engineered B cell company, today announced a historic achievement: the safe and well-tolerated re-dosing of a patient with a gene modified therapeutic product candidate. The patient in Immusoft’s first-in-human clinical study has now received two doses – separated by 18 months1 – of ISP-001 to treat mucopolysaccharidosis type I (MPS I), with an excellent safety and tolerability profile, to date. Moreover, Immusoft continues to observe positive results in this ongoing clinical trial. This is a momentous event for Immusoft and for the broader gene therapy community, which has long sought the ability to
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