Universal Off-the-Shelf, Ready to Use
iPSC-derived cells are clonal and homogeneous, enabling true mass production. Products are cryopreserved and can be administered immediately upon patient need – no weeks-long manufacturing wait.
ImmuCell™ Platform
An off-the-shelf iPSC-derived immune cell platform for scalable and affordable cell therapy development.
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Platform Overview
ImmuCell™ Platform: Breaking the Barriers of Autologous Cell Therapy
Current cell therapies face major hurdles: autologous CAR-T requires individualized manufacturing, leading to long waiting times and prohibitive costs, while efficacy against solid tumors remains limited. Protheragen addresses these challenges with its ImmuCell™ platform – a next-generation immune cell therapy engine. By developing clonal, homogeneous iPSC master cell banks and directing them into functional NK or T cells, ImmuCell™ enables universal off-the-shelf, scalable production of immune cell drugs for solid tumors and autoimmune diseases – drastically reducing costs and improving patient access.
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Disruptive Technology
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Excellent Team
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Diversified Pipeline
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Customized Solutions
Platform Core
From iPSC Engineering to Functional Immune Cells
The ImmuCell™ platform is built upon a proprietary iPSC-based foundation that enables universal, scalable, and consistent production of off-the-shelf immune cell therapies. From a single clonal iPSC master cell bank, we apply precise gene editing to introduce CARs and safety features, followed by directed differentiation into two distinct functional cell types – iPSC-CAR-iNK (engineered natural killer cells for non-MHC-restricted antitumor activity) and iPSC-CAR-iT (engineered T cells combining iPSC scalability with proven cytotoxic machinery) – each optimized for specific therapeutic applications.
- iPSC Master Cell Bank: Establishment of high-quality, clonal, homogeneous three-tier (EOP, MCB, WCB) iPSC cell banks as the standardized source for all downstream production.
- Gene Editing: Engineering of iPSC seed cells with chimeric antigen receptors (CARs), safety switches, and enhanced functionality using precise gene editing tools.
- Directed Differentiation & Expansion: Scalable, stable, and GMP-ready differentiation of edited iPSCs into functional off-the-shelf iNK cells or iT cells with potent anti-tumor activity.
- Drug Substance / Drug Product: Final formulation into cryopreserved, ready-to-administer immune cell drug products with consistent quality across batches.
Platform Advantages
Unique Advantages of the ImmuCell™ Platform
Broad Indication Coverage
iPSCs can be differentiated into multiple functional cell types (NK, T, etc. ), allowing the platform to address diverse indications including solid tumors, autoimmune diseases, and beyond.
Low Cost, High Accessibility
Mass production of universal cell products fundamentally breaks the cost barrier of autologous CAR-T. One iPSC master bank can supply thousands of patient doses, significantly reducing manufacturing costs and improving patient access.
Platform Application
Broad Therapeutic Potential of iPSC-Derived Immune Cells
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Solid Tumor Immunotherapy
The core focus of the platform. iPSC-CAR-iNK/iT cells are engineered to infiltrate solid tumors, overcome the immunosuppressive microenvironment, and exert potent cytotoxicity against various solid tumor types.
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Autoimmune Disease Treatment
Differentiation of iPSCs into immunoregulatory cells – such as engineered regulatory T cells or tolerogenic NK cells – to precisely suppress aberrant immune responses in autoimmune conditions.
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Allogeneic Universal Cell Therapy
Platform-derived iNK or iT cells are inherently “off-the-shelf” allogeneic products. They can be used for large-scale, standardized clinical treatment, breaking the patient-specific limitation of autologous therapies.
Pipeline
Research & Development Pipeline
| Projects | Therapy Type | Target | Indication | Discovery | Preclinical | IND | Phase I | Phase II | Phase III |
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| IMC005 | iPSC-CAR-iNK | HER2 | HER2-positive Solid Tumors | ||||||
| IMC013 | iPSC-CAR-iT | GPC3 | Hepatocellular Carcinoma | ||||||
| IMC021 | iPSC-derived iTreg | FoxP3+ | Rheumatoid Arthritis (RA) | ||||||
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FAQs
Frequently Asked Questions
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Q1: What makes iPSC-derived cell therapy different from autologous CAR-T?
A1: Autologous CAR-T requires harvesting each patient's own T cells, engineering them, and re-infusing – a costly 2-4 week process. Our ImmuCell™ platform starts with a single, well-characterized iPSC master bank that can produce thousands of off-the-shelf doses ready for immediate use. -
Q2: How do you prevent graft-versus-host disease (GvHD) with allogeneic cells?
A2: We perform targeted gene editing to disrupt HLA class I/II molecdles and knock out TCR expression, creating "universal" cells that evade recipient T cell recognition without causing GvHD. -
Q3: Can ImmuCell™ treat solid tumors?
A3: Yes – and this is our primary focus. We equip iNK and iT cells with CARs specific to solid tumor antigens and further engineer them to resist the immunosuppressive tumor microenvironment. -
Q4: What is the advantage of clonal iPSC banks?
A4: A single clonal iPSC line provides a genetically identical, well-characterized starting material for all production batches. This eliminates the donor-to-donor variability inherent in primary cells. -
Q5: What autoimmune diseases can this platform target?
A5: We can engineer iPSC-derived regdlatory T cells (Tregs) or tolerogenic NK cells to suppress inflammation. Potential indications include lupus, rheumatoid arthritis, type 1 diabetes, and inflammatory bowel disease.
ImmuCell™ is a proprietary iPSC-derived universal off-the-shelf cell therapy platform engineered to deliver scalable, affordable, and ready-to-use iNK and iT cells for solid tumors and autoimmune diseases.
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