Ernexa Therapeutics (ERNA) unveiled breakthrough preclinical results showing that its lead cell therapy candidate, ERNA-101 achieved complete tumor elimination and 100% long-term survival when combined with PD-1 blockade in syngeneic ovarian cancer models.
The company said the findings highlight the therapy's potential to overcome one of the biggest challenges in ovarian cancer- an immunologically "cold" tumor microenvironment.
Ovarian cancer, particularly high-grade serous ovarian carcinoma, remains a major unmet medical need, with most patients diagnosed at advanced stages and limited benefit from current immunotherapies due to strong tumor-driven immune suppression. Ernexa's new data suggest ERNA-101 may help unlock the full potential of checkpoint inhibitors in this setting.
In the study, ERNA-101 combined with anti-PD-1 therapy led to complete tumor clearance and 100% survival through long-term follow-up, significantly outperforming either therapy alone or suggesting potential curative activity.
The treatment also remodeled the tumor microenvironment from immunosuppressive to immune-activated, enabling stronger and more durable anti-tumor immune responses.
Key findings from the preclinical studies include:
- Complete tumor clearance and survival with combination therapy
- Remodeling the tumor microenvironment from immunosuppressive to immune-activated.
- Increased activity, survival, and persistence of cancer-fighting T cells.
- Greater infiltration of CD4+ and CD8? T cells into tumors
- Macrophage reprogramming toward a tumor-fighting state
- Reduced tumor burden and decreased ascites accumulation.
Robert H. Pierce, M.D., CSO said the results demonstrate "complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself". CEO Sanjeev Luther, added that the data "reinforce both the strength of the response and the underlying mechanism driving this response" noting the potential for ERNA-101 to enhance checkpoint inhibitor activity across other immunologically cold solid tumors as well.
ERNA-101 is an allogeneic induced mesenchymal stem cell (iMSC) therapy engineered to home to tumors and secrete a potent IL-7/IL-15 fusion cytokine directly within the tumor microenvironment, aiming to maximize immune activation while minimizing systemic toxicity.
Ernexa plans to incorporate these findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in advanced ovarian cancer. Ongoing studies are evaluating the therapy in combination with checkpoint inhibitors and other immuno-oncology agents.
The company implemented a 1-for-15 reverse stock split on June 9, 2025.
ERNA is currently trading at $5.54, up 35%.
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