Immusoft Awarded $8M in Funding from the California Institute for Regenerative Medicine


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 it has received an $8 million grant from the California Institute for Regenerative Medicine. This funding will support a Phase I study to assess the safety and tolerability of ISP-001 in MPS I, a rare genetic disease that affects children. The study’s Investigational New Drug Application was approved by the US Food and Drug Administration on September 1, 2022, as previously announced by Immusoft.

This clinical trial is significant for Immusoft as well as historic in the field of cell and gene therapies because ISP-001 will be the first engineered B cell therapy to enter human clinical trials. Immusoft pioneered the engineering of B cells to create biofactories for in vivo therapeutic protein delivery, holding over 60 issued and pending patents in the field.

The company’s novel B cell platform was created to avoid the immunogenicity associated with virus-delivered gene therapy and the chemotherapy preconditioning associated with stem cell-mediated gene therapy, while also allowing for long-term therapeutic delivery and the ability to re-dose. This platform could be used to treat rare diseases and other conditions that can be treated with protein therapeutics.

In addition to funding for its MPS I clinical trial, Immusoft received a $4 million CIRM grant in November 2021 to support the development of its ISP-002 program for MPS II. In addition, Immusoft has formed a research collaboration and license option agreement with Takeda Pharmaceutical Company Limited to deliver protein therapeutics across the blood-brain barrier to treat neurometabolic disorders.

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