Engineering Stem Cells to Target Disease at Its Source

Engineering induced-mesenchymal stem cells (iMSCs) to target disease at its source

Ernexa Therapeutics is advancing a new generation of cell therapies to treat advanced cancers and autoimmune diseases. Our platform is built on engineering induced pluripotent stem cells (iPSCs) into synthetic iMSCs – a specialized cell type uniquely capable of homing to sites of inflammation or tumors.

Unlike autologous therapies requiring cell harvest from each patient or allogeneic approaches involving cells from numerous donors, Ernexa’s allogeneic and off-the-shelf therapy creates synthetic iMSCs from a single healthy donor and enhances them through bioengineering. We produce consistent, scalable therapies that can be used across multiple patients.

This approach addresses the limitations of earlier MSC-based treatments, like variability, immune rejection, and poor persistence, and enables disease-specific optimization of therapeutic potency. Through additional engineering, our iMSCs are designed to express potent cytokines, delivering anti-inflammatory or immune-stimulating signals precisely where they’re needed most.

Oncology

Overcoming the Immune Blockade in Solid Tumors

Checkpoint inhibitors have transformed cancer care, yet the majority of patients still do not respond. This is especially true for "cold" tumors that lack active immune cells that can infiltrate the tumor. A key barrier is the tumor microenvironment itself, which often blocks immune cells from entering and suppresses their activity once inside.

ERNA-101, A Novel Cell Therapy Designed to Turn Immunologically “Cold” Tumors “Hot”

ERNA-101 uses Ernexa Therapeutics’ proprietary platform to engineer iMSCs from induced pluripotent stem cells (iPSCs). These synthetic iMSCs are designed to home to tumors and deliver two powerful immune-activating signals – IL-7 and IL-15 – directly into the tumor microenvironment. Together, these cytokines help T cells and NK cells expand, infiltrate tumors, resist exhaustion, and sustain their anti-tumor activity.

By focusing on immune activation within the tumor itself, ERNA-101 aims to minimize systemic toxicity while enhancing the immune system’s ability to recognize and destroy cancer cells. This approach offers potential as both a standalone therapy and a synergistic partner to checkpoint inhibitors, T cell therapies, cancer vaccines, and other immuno-oncology strategies.

Lead Focus in Ovarian Cancer

Ovarian cancer remains a challenging disease with few effective targeted therapies, limited immunotherapy success, high rates of recurrence, and frequent development of resistance to platinum-based chemotherapy.

Preclinical studies suggest that ERNA-101 cells specifically track to ovarian tumors, infiltrate into the tumor microenvironment, and trigger immune responses. This lays a strong foundation for improved outcomes in this difficult-to-treat cancer and beyond.

Autoimmune Disease

Combatting Overactive Immune Responses

Autoimmune diseases arise when the immune system turns against the body’s own tissues, driving chronic inflammation and long-term damage. A key player in this process is the inflammatory macrophage, which is an immune cell that acts as a gatekeeper for either escalating or resolving inflammation.

IL-10 is a well-studied anti-inflammatory molecule that plays a critical role in calming overactive immune responses. Its ability to regulate immune cell activity makes it a promising therapeutic candidate for treating a wide range of autoimmune diseases and inflammatory conditions in general. However, previous attempts to deliver IL-10 systemically have fallen short in the clinic, likely due to its short half-life and the inability to concentrate the molecule where it’s needed most: inflamed tissue.

ERNA-201, Directly Targeting Sites of Inflammation

At Ernexa Therapeutics, we’re taking a different approach. Our cell therapy product, ERNA-201, is built on our proprietary synthetic iMSC platform and engineered to deliver IL-10 directly to sites of inflammation. These iMSCs are designed to home in on diseased tissue and convert inflammatory macrophages into a healing, anti-inflammatory state.

By targeting the cells that drive inflammation and delivering IL-10 locally – where it matters most – ERNA-201 aims to reset the immune system, reduce tissue damage, and promote repair. Our initial focus is on rheumatoid arthritis, with the potential to expand into a broad range of autoimmune diseases.

Publications

Scientific rigor is central to everything we do at Ernexa Therapeutics. Explore our published studies to learn more about the science behind our cell therapy platform and the data driving our work in oncology and autoimmune disease.

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