Immusoft

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

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...
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Gene and Cell Therapies in Focus at ASGCT 2025: Tackling Rare Diseases, Autoimmune Conditions, and More

Immusoft, a California-based cell therapy innovator, is presenting the world’s first clinical trial data for engineered B cells targeting mucopolysaccharidosis type I (MPS I), a rare genetic disorder caused by a deficiency in the enzyme iduronidase. This condition triggers a harmful buildup of substances, leading to severe developmental and physical challenges. At ASGCT 2025, Paul J. Orchard, MD, from the University of Minnesota, will share results from a first-in-human trial, highlighting the safety and early efficacy of autologous B cells...
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Immusoft Reports Promising Early Data for Lead Candidate in MPS I

Nearly a year after making cell therapy history by dosing the first patient with the first engineered B cell in a human trial, Immusoft has reported promising but early clinical data showing its lead candidate was effective nine months after dosing, as well as safe. Immusoft has presented data from its Phase I trial (NCT05682144) assessing ISP-001 nine months after administering a single low dose of 2.5 x 107 cells/kg in a patient with mucopolysaccharidosis type I (MPS I). The...
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Immusoft to Announce Positive Phase 1 Data for First Engineered B Cell Therapy in a Clinical Trial

Immusoft of CA, a wholly owned subsidiary of Immusoft Corporation (""Immusoft""), a cell therapy company dedicated to improving the lives of patients with rare diseases, today announced positive results from the Phase 1 ISP-001 trial evaluating the therapy in a patient with mucopolysaccharidosis type I (MPS I). The clinical trial is supported by an $8 million award from the California Institute for Regenerative Medicine (CIRM), one of the world's largest institutes dedicated to regenerative medicine. ""Although the Phase 1 focus...
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Immusoft To Present on ISP-001 Clinical Trial at WORLDSymposium™ 2024 Conference

Immusoft Corporation, a cell therapy company dedicated to improving the lives of patients with rare diseases, today announced that it will present at the upcoming WORLDSymposium 2024 Conference, held in San Diego, February 4-9, 2024. WORLDSymposium is the largest international gathering of lysosomal disease researchers. Immusoft is developing a new modality of gene encoded medicine that holds the promise of being durable and redosable. The Company’s lead investigational drug candidate ISP-001, is a first-in-class investigational treatment for mucopolysaccharidosis type I...
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In a World First, a Patient’s Antibody Cells Were Just Genetically Engineered

Our B cells help prevent us from getting sick. Their job is to make antibodies, immune system proteins that fight off viruses and other foreign invaders. And they make a lot of antibodies—thousands of them every second. What if these antibody factories could be harnessed to make other things the body needs? That’s the idea behind a trial launched by Seattle-based biotech company Immusoft. The company announced today that its scientists have genetically programmed a patient’s B cells and put...
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Researchers Genetically Program B Cells to Treat Genetic Disorder

A Seattle-based biotech company is conducting a trial using genetically programmed B cells to treat a genetic disorder called mucopolysaccharidosis type I (MPS I). The disorder causes a lack of an essential enzyme that breaks down long-chain sugars in the body. This enzyme deficiency leads to life-threatening symptoms, including cloudy eyes, respiratory problems, cognitive issues, and enlarged organs. Patients with MPS I currently receive weekly infusions of the missing enzyme, but Immusoft, the biotech company conducting the trial, aims to...
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Immusoft Administers the First Engineered B Cell in a Human Clinical Trial

Immusoft of CA, a wholly owned subsidiary of Immusoft Corporation (“Immusoft”), a clinical-stage cell therapy company dedicated to improving the lives of patients with rare diseases, today announced the first patient dosed with engineered B cell therapy ISP-001 in a Phase 1 trial in MPS I, at M Health Fairview University of Minnesota Medical Center. MPS I is a rare, genetic disease that affects the body’s ability to produce the enzyme alpha-L-iduronidase (IDUA), which is an essential enzyme that helps...
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Immusoft Acquires Exclusive, Worldwide Rights to Intellectual Property for Genome Edited Primary B Cells from the University of Minnesot

Immusoft, a clinical-stage cell therapy company dedicated to improving the lives of patients with rare diseases, today announced that it has successfully closed a license with the Regents of the University of Minnesota for the exclusive, worldwide rights to intellectual property (IP) for compositions of matter and methods to make and use genome edited primary B cells. The parent patent application is titled, “Genome Edited Primary B cell and Methods of Making and Using.” The IP includes proprietary methods that...
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Immusoft Awarded $8M in Funding from the California Institute for Regenerative Medicine (CIRM) for MPS I Clinical Program

Immusoft of CA, a wholly owned subsidiary of Immusoft Corporation, a clinical-stage cell therapy company dedicated to improving the lives of patients with rare or genetic diseases, announced today that the California Institute for Regenerative Medicine (CIRM) has awarded the company an $8M grant. This funding will support a Phase I study to evaluate the safety and tolerability of ISP-001 (for delivery of alpha-L-iduronidase, or IDUA) in MPS I a rare, childhood genetic disease. The Investigational New Drug Application for...
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