Ernexa Therapeutics (NASDAQ: ERNA) presented new preclinical data for its lead candidate ERNA‑101 at the American Society of Hematology (ASH) Annual Meeting on December 8, 2025. The oral presentation, led by MD Anderson Cancer Center researcher Michael Andreeff, showed that the company’s IL‑7/IL‑15‑secreting induced mesenchymal stem cells (iMSCs) produced cytokine levels roughly 20‑fold higher than those seen with engineered T‑cell therapies.
In an immunocompetent ovarian cancer model, intraperitoneal delivery of the iMSCs triggered robust immune cell infiltration, re‑polarized macrophages toward a pro‑inflammatory phenotype, and converted the tumor microenvironment from a “cold” to a “hot” state. The treatment also extended survival in the animal model, underscoring the platform’s potential to overcome resistance in both solid tumors and hematologic malignancies.
Sanjeev Luther, President & CEO, said the ASH presentation “is a tremendous honor and a major milestone that validates the promise of our iMSC platform to transform the tumor microenvironment and drive a targeted immune response.” Dr. Andreeff added, “Delivering cytokines directly into tumors represents a powerful, clinically relevant strategy, and these data highlight the ability of iPSC‑derived MSCs to be repurposed from their historical immunosuppressive roles into highly effective, immune‑activating delivery vehicles.”
The data reinforce the scientific foundation for ERNA‑101’s first‑in‑human trials, slated for 2026, and position Ernexa to pursue scalable, off‑the‑shelf cell therapies for cancer and autoimmune diseases. The company also highlighted its ERNA‑201 program, targeting autoimmune disorders, as part of a broader pipeline that seeks to leverage the same iMSC platform across multiple indications.
While Ernexa remains a small, early‑stage company with a market cap of just over $10 million and a 70% decline in its share price year‑to‑date, the preclinical results provide a compelling narrative of scientific progress and a clear path toward clinical development, strengthening the company’s competitive stance in the rapidly evolving cell‑therapy landscape.
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