Immusoft
Immusoft is a clinical-stage biotechnology company developing engineered B cell therapies using its ISP™ platform, with lead asset ISP-001 in Phase 1/2 trials for MPS I and pipeline programs for MPS II and other rare diseases, serving patients with rare genetic disorders via academic medical center clinical trials.
- Company typePrivate
- Founded2009
- HeadquartersSeattle, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Immusoft does
Immusoft is a clinical-stage biotechnology company founded in 2009 and headquartered in Seattle (parent, Immusoft Corporation) with operating subsidiary Immusoft of CA, Inc. based in San Francisco. The company develops engineered B cell therapies using its proprietary Immune System Programming (ISP™) platform, which isolates a patient's B cells, programs them ex vivo with a therapeutic gene via the non-viral Sleeping Beauty transposon system, expands them into plasma cell biofactories, and reinfuses them to produce therapeutic proteins continuously for extended periods. Lead asset ISP-001 programs B cells to secrete alpha-L-iduronidase (IDUA) for mucopolysaccharidosis type I (MPS I, Hurler syndrome) and is in Phase 1/2a trials at the University of Minnesota and UCSF Benioff Children's Hospitals, with FDA Orphan Drug, Rare Pediatric Disease, and Fast Track designations. Second asset ISP-002 delivers iduronate-2-sulfatase (IDS) for MPS II (Hunter syndrome) and has Orphan Drug and Rare Pediatric Disease designations. The company is venture-backed ($20M Series B in 2019), has received cumulative non-dilutive grant funding exceeding $30M from CIRM and NIH, and has a research collaboration with Takeda valued at up to $900M in milestones for CNS-manifesting neurometabolic disorders.
Immusoft's business model is pre-commercial; current cash inflows derive from non-dilutive grant funding (CIRM, NIH SBIR) and an upfront plus research funding arrangement with Takeda, with future revenue contingent on either licensing milestones, royalties, or eventual commercialization of approved products. Customer-facing operations are limited to clinical trial sites for investigational therapy administration. Distribution does not exist in the commercial sense; therapies are delivered under FDA-cleared IND protocols. The company's go-to-market posture is enterprise field sales in the sense of academic medical center partnerships and principal investigator relationships, with future commercialization expected to follow standard biopharmaceutical distribution channels contingent on regulatory approval.
The company's competitive positioning rests on a 60+ patent portfolio (including exclusive worldwide rights to University of Minnesota genome-edited B cell IP), first-in-human clinical validation including the first-ever successful re-dosing of a gene-modified therapeutic candidate at 18 months, and a leadership team with prior successful biotech exits (RetroSense/Allergan up to $555M, FivePrime/Amgen). Pipeline indications extend beyond MPS I and MPS II into Gaucher disease, Parkinson's, obesity/diabetes, oncology, and autoimmune conditions.
Immusoft firmographics
Firmographics- Name
- Immusoft
- Legal name
- Immusoft Corporation
- Website
- http://immusoft.com
- Company type
- Private
- Founded year
- 2009
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Immusoft is a clinical-stage biotechnology company developing engineered B cell therapies using its ISP™ platform, with lead asset ISP-001 in Phase 1/2 trials for MPS I and pipeline programs for MPS II and other rare diseases, serving patients with rare genetic disorders via academic medical center clinical trials.
- Ownership category
- akta.pro rank
Immusoft industry classification
Industry- Product category
- Cell Therapy / Gene Therapy for Rare Diseases
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Cell Therapy Developers (Autologous) (HLAAABAA)
- akta.pro secondary industries
- Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Immunology & Inflammation Pharmaceuticals (HLAIAAAD)
Keywords
Where Immusoft is headquartered
LocationHeadquarters
- HQ city
- Seattle
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Immusoft business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Revenue model
- Biopharmaceutical Product Revenue: Revenue from development and commercialization of engineered B cell therapies for rare genetic diseases. Lead programs (ISP-001, ISP-002) target lysosomal storage disorders with significant unmet medical needs. Pipeline includes programs in Gaucher disease, Parkinson's, obesity/diabetes, oncology, and autoimmune diseases.
- Partnership and Milestone Payments: Takeda collaboration valued at over $900 million in potential milestones, option fees, and royalties for CNS/neurometabolic disorders. CIRM grants ($4M, $8M, $15M) for clinical development of MPS I and MPS II programs.
- Government Grants and Non-Dilutive Funding: NIH SBIR Phase II grant of $3.5 million for blood-brain barrier delivery research. CIRM grants totaling up to $23M for MPS I clinical program and MPS II development.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
Immusoft product offering
Product offeringCore offering
Immusoft is a clinical-stage biotechnology company developing engineered B cell therapies using its proprietary Immune System Programming (ISP) platform. The technology collects a patient's B cells, programs them ex vivo to produce specific therapeutic proteins, expands and differentiates them into plasma cell biofactories, and infuses them back into the patient where they continuously secrete therapeutic proteins. Its lead asset, ISP-001, is the first engineered B cell therapy in human clinical trials, delivering alpha-L-iduronidase for mucopolysaccharidosis type I (MPS I).
Product overview
Immusoft is a clinical-stage biotechnology company pioneering engineered B cell therapies using its proprietary Immune System Programming (ISP) platform. The company's core product is ISP-001, the first-ever clinical-stage engineered B cell therapy for mucopolysaccharidosis type I (MPS I), currently in Phase 1/2a trials with FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Pipeline product ISP-002 targets MPS II and is in preclinical development. The ISP platform enables B cells to be programmed as living biofactories for sustained delivery of therapeutic proteins, with programs also in Gaucher disease, Parkinson's, obesity/diabetes, oncology, and autoimmune indications.
Differentiator
Problem solved
Functional benefit
Products and services
- ISP-001 ISP-001 is the first-ever clinical-stage engineered B cell therapy that programs a patient's own B cells to continuously produce and secrete alpha-L-iduronidase (IDUA) enzyme for the treatment of mucopolysaccharidosis type I (MPS I). It is currently in Phase 1/2a clinical trials conducted at the University of Minnesota Medical School and UCSF Benioff Children's Hospitals.
- ISP-002 ISP-002 is an investigational engineered B cell therapy for mucopolysaccharidosis type II (MPS II, Hunter syndrome), programming patient B cells to produce iduronate-2-sulfatase (IDS) enzyme. It is in preclinical development with FDA Orphan Drug and Rare Pediatric Disease designations.
- Immune System Programming (ISP) Platform Immusoft's proprietary Immune System Programming (ISP) platform modifies a patient's own B cells ex vivo to function as biofactories (plasma cells) that manufacture and secrete therapeutic proteins continuously after reinfusion. The platform uses a non-viral Sleeping Beauty transposon system for gene delivery, enables re-dosing without immune response, and does not require chemotherapy preconditioning. It is the foundation for all Immusoft pipeline programs and underpins the Takeda collaboration for CNS/neurometabolic disorders.
Quantifiable outcome
- Early clinical data shows favorable safety and tolerability with no adverse events reported as of data cutoff
- +4 more outcomes
Companies that use Immusoft
Customer profileNamed customers2 records
Segments2 records
Ideal customer profiles3 records
Immusoft technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Immusoft partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and flagship.
- University of Minnesota Medical SchoolcoreClinical trial site for ISP-001 Phase 1/2 study. Dr. Paul Orchard serves as Principal Investigator. Discovery Genomics, Inc. (founded by Dr. McIvor) was acquired by Immusoft in 2016.
- UCSF Benioff Children's HospitalscoreClinical trial site for ISP-001 study. Dr. Paul Harmatz serves as clinical investigator.
- University of MinnesotacoreLicense agreement for exclusive, worldwide rights to intellectual property for genome edited primary B cells. Parent patent titled 'Genome Edited Primary B cell and Methods of Making and Using' covers delivery of targeted nucleases for precise genome engineering and resultant compositions of matter.
- Takeda Pharmaceutical Company LimitedflagshipResearch collaboration and license option agreement for discovering, developing, and commercializing cell therapies for rare inherited metabolic disorders with CNS manifestations using Immusoft's ISP™ platform. Immusoft receives undisclosed upfront payment, research funding, and is eligible for up to $900M in option fees and milestone payments if all options are exercised. Takeda gets rights to exclusively license programs at preclinical stage and pays tiered royalties on future products.
Scale indicators11 records
Recent moves6 records
Expansion highlights6 records
Immusoft competitors and assessment
Company assessmentBroad incumbents
- BioMarin Pharmaceutical: Established rare disease biotech with Aldurazyme (enzyme replacement therapy for MPS I) — directly competing with Immusoft's lead ISP-001 program and providing the incumbent standard of care that Immusoft must displace.
Direct peers
- bluebird bio: Clinical-stage gene and cell therapy developer for rare genetic diseases; directly comparable to Immusoft as a small-cap, modality-focused rare disease biotech pursuing first-in-class or best-in-class cell-engineering approaches.
- Sangamo Therapeutics: Clinical-stage gene therapy and genome editing company developing engineered cell therapies for rare metabolic diseases; directly comparable as a platform-based genomic medicine developer pursuing similar patient populations and regulatory pathways.
- uniQure: Clinical-stage gene therapy company developing AAV-based therapies for rare diseases including CNS and metabolic indications; comparable in modality approach (gene-modified cells for protein delivery) and disease focus areas.
- Abeona Therapeutics: Clinical-stage gene and cell therapy company focused on rare diseases including MPS (their MPS IIIA program directly targets the same disease family as Immusoft's lead indications); highly comparable in scale, stage, and therapeutic focus.
- REGENXBIO: Clinical-to-commercial gene therapy company developing AAV-based treatments for rare diseases including MPS II (Hunter syndrome) — directly competing with Immusoft's ISP-002 program using a different delivery modality.
Emerging players
- Passage Bio: Clinical-stage genetic medicines company focused on CNS disorders using AAV gene therapy; comparable as an early-stage rare disease biotech with CNS-focused pipeline, though using a different delivery modality (AAV vs. engineered B cells).
- Generation Bio: Clinical-stage genetic medicines company developing non-viral gene therapies for rare diseases; directly comparable to Immusoft in pursuing non-viral delivery approaches (Immusoft uses Sleeping Beauty transposon vs. Generation Bio's ctLNP platform) for similar therapeutic areas.
- Taysha Gene Therapies: Clinical-stage gene therapy company developing AAV-based treatments for rare CNS diseases; comparable as a small-cap rare disease biotech with similar disease focus and development stage, though using viral delivery.
- Voyager Therapeutics: Clinical-stage gene therapy company developing AAV-based treatments for CNS and rare diseases; comparable as a platform-based genetic medicine developer targeting similar patient populations and indications including CNS/neurometabolic disorders.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Immusoft social profiles
Digital presenceImmusoft financial estimates
Financial estimateRevenue estimate
Valuation estimate
Immusoft leadership team
Management profileNumber of profiles
Profiles8 records
Immusoft subsidiaries and ownership
Company hierarchySubsidiaries1 record
Immusoft funding detail
Funding detailFunding overview
Funding rounds14 records
Investors21 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Immusoft M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Immusoft
What does Immusoft do?
Immusoft is a clinical-stage biotechnology company developing engineered B cell therapies using its proprietary Immune System Programming (ISP) platform. The technology collects a patient's B cells, programs them ex vivo to produce specific therapeutic proteins, expands and differentiates them into plasma cell biofactories, and infuses them back into the patient where they continuously secrete therapeutic proteins. Its lead asset, ISP-001, is the first engineered B cell therapy in human clinical trials, delivering alpha-L-iduronidase for mucopolysaccharidosis type I (MPS I).
Is Immusoft a public or private company?
Immusoft is a private company. It is classified as venture growth investor backed and is currently operating.
When was Immusoft founded?
Immusoft was founded in 2009. It employs 11 to 50 people.
Where is Immusoft based?
Immusoft is headquartered in Seattle, United States, in the North America region.
How does Immusoft make money?
Three revenue lines are on record. Biopharmaceutical Product Revenue is the primary driver. The others are partnership and Milestone Payments and government Grants and Non-Dilutive Funding.
Who are Immusoft's main competitors?
BioMarin Pharmaceutical is listed as a broad incumbent. Direct peers are bluebird bio, Sangamo Therapeutics, uniQure, Abeona Therapeutics and REGENXBIO. Emerging players are Passage Bio, Generation Bio, Taysha Gene Therapies and Voyager Therapeutics.
Does Immusoft have an API?
No public API is recorded for Immusoft.
What industry is Immusoft in?
Immusoft's product category is Cell Therapy / Gene Therapy for Rare Diseases. Its primary akta.pro industry code is HLAAABAA, Cell Therapy Developers (Autologous), with a secondary code of HLAAAAAB, Recombinant Protein Therapeutics (enzymes, hormones, growth factors). Its NAICS code is 325414 and its SIC code is 2836.