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    BioSpace | February 04, 2026

    From Awareness to Acceleration: Rare Disease Drug Development Enters a Pivotal Era

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    • Press Releases
    January 26, 2026

    Immusoft Receives FDA Rare Pediatric Disease Designation for ISP-002 to treat Mucopolysaccharidosis Type II

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    Designation recognizes ISP-002, an engineered B cell therapy designed for sustained enzyme delivery SAN FRANCISCO, Jan. 26, 2026 /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 Rare…

    • News Articles
    Genetic Engineering & Biotechnology News | January 13, 2026

    Fast-Tracked CGT Platform Eliminates Patient Preconditioning

    Immusoft’s MPS 1 CGT therapeutic hurdles traditional barriers, eliminating patient preconditioning and enabling redosing

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    • Press Releases
    December 15, 2025

    Immusoft Secures FDA Orphan Drug Designation for ISP-002 in MPS II, a Progressive Lysosomal Storage Disease

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    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,…

    • Publications & Presentations
    December 09, 2025

    Engineering B Cells With Immusoft’s Sean Ainsworth

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    • Press Releases
    PR Newswire | October 21, 2025

    Immusoft Receives FDA Fast Track Designation for ISP-001, a First-in-Class Engineered B Cell Therapy for MPS I

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    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…

    • Press Releases
    October 07, 2025

    In a Major Breakthrough for Cell and Gene Therapy, Immusoft Has Re-dosed a Patient with ISP-001 in Its Lead Program for MPS I

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    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…

    • Publications & Presentations
    Beyond Biotech | May 20, 2025

    Fighting mucopolysaccharidosis type I, a rare disease, by reprogramming B-cells

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    • Press Releases
    May 13, 2025

    Immusoft to Present Data at ASGCT 2025, Demonstrating Positive Results from the World’s First Engineered B Cell in a Human Clinical Trial

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    Safety and initial activity of autologous human B cells engineered to express the enzyme iduronidase. Results from a first-in-human clinical trial in subjects with MPS I SAN FRANCISCO, May 13, 2025 /PRNewswire/ — Immusoft of CA, a cell therapy company dedicated to improving the lives…

    • News Articles
    Citeline | February 27, 2025

    Immusoft Goes For Cell Therapy Plan ‘B’

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