Immusoft to Present Data Highlighting Positive Results from the World’s First Engineered B Cell in a Human Clinical Trial at ASGCT 2026

SAN FRANCISCO, May 06, 2026 (GLOBE NEWSWIRE) -- Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that Scott McIvor, Chief Development Officer at Immusoft, will present recent clinical data in a poster presentation at the American Society of Cell and Gene Therapy (ASGCT) 29th Annual Meeting, taking place May 11-15, 2026, in Boston, MA.

“We’re pleased to share data that continue to reinforce the potential of ISP-001 as a differentiated approach for patients with MPS I,” said Sean Ainsworth, Chief Executive Officer of Immusoft. “We have observed favorable safety and tolerability to date, alongside encouraging biochemical activity, including the ability to safely re-dose patients. Together, these results support continued development of ISP-001 in adult patients and the planned expansion into pediatric populations, where the need for durable treatment options remains significant.”

Presentation Details

Abstract: 2371

Title: First-in-human clinical trial of autologous human B cells engineered to express human iduronidase in subjects with MPS I: Support for pediatric studies

Date and Time: Wednesday, May 13, 05:00 PM - 06:30 PM ET

The trial is supported by up to $23 million in funding from the California Institute for Regenerative Medicine (CIRM), which funds cell and gene therapy research and clinical trials in California.

About MPS I (Mucopolysaccharidosis type I)

MPS I (Mucopolysaccharidosis type I) is a rare, lethal childhood genetic disease that currently has no cure. It affects the body’s ability to produce IDUA (alpha-L-iduronidase), an essential enzyme in the breakdown of sugar molecules in cells called glycosaminoglycans (GAGs). When GAGs can’t be broken down, they accumulate in cells throughout the body, causing organ damage and leading to early death. MPS I occurs in approximately 1 in 100,000 live births, with symptoms appearing within the first year of life for the most severe form, Hurler Syndrome. Children affected with the Hurler form of MPS I rarely live more than ten years after diagnosis, if left untreated.

About ISP-001

ISP-001 is the first ever clinical-stage engineered B cell therapy that deploys a patient’s own cells to function as “living biofactories”, which continuously produce and secrete potentially therapeutic proteins. ISP-001 is specifically designed to secrete therapeutic levels of α-L-iduronidase (IDUA), the enzyme deficient in MPS I patients. By leveraging the natural biology of B cells, ISP-001 aims to overcome key challenges associated with current therapies, including the “sawtooth effect” (spike and trough enzyme levels) associated with frequent enzyme replacement therapy infusions, as well as mortality and safety concerns associated with stem cell transplants.

ISP-001 has received Orphan Drug, Rare Pediatric Disease, and Fast Track designations from the U.S. Food and Drug Administration and is currently being evaluated in a Phase 1/2 clinical trial. For more information about the trial, visit clinicaltrials.gov (NCT05682144).

About Immusoft

Immusoft of CA is a wholly owned subsidiary of Immusoft Corporation. Immusoft is a clinical-stage company focused on developing novel therapies for rare diseases using sustained delivery of protein therapeutics from a patient’s own cells. The company has developed a technology platform called Immune System Programming (ISP™), which modifies a patient’s B cells and instructs the cells to produce gene-encoded medicines. The B cells reprogrammed with ISP become miniature protein-therapeutic biofactories that are expected to persist for many years. For more information, visit www.immusoft.com and follow us on LinkedIn.

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Adam Silverstein
SCIENT
adam@scientpr.com

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