Immusoft reported progress in its Immune System Programming (ISP) ex‑vivo CGT platform, which the company says enabled the first clinical redosing of an ex‑vivo cell‑based gene therapy without patient preconditioning. The platform uses autologous B cells as living protein factories and is in a Phase I/IIa trial for mucopolysaccharidosis type I (MPS I). Redosing capability addresses a central limitation of AAV‑based in vivo CGTs—neutralizing antibodies that prevent repeat dosing—and could permit annual or adjustable dosing regimens. Immusoft’s lead program, ISP‑001, received FDA Fast Track designation and the company is optimizing dosing in ongoing early trials. Immusoft executives emphasized clinical tolerability, the potential to tailor doses over time for patients and the downstream implications for payers and access models if redosing proves safe and effective.