Ernexa Therapeutics (NASDAQ: ERNA) announced preclinical data showing its cell therapy candidate ERNA-101 achieved complete tumor clearance and 100% survival in ovarian cancer models when combined with PD-1 blockade therapy.

The Cambridge, Massachusetts-based company reported that the combination treatment eliminated detectable tumors and resulted in 100% survival through long-term follow-up in syngeneic ovarian cancer models. The outcomes exceeded those observed with either therapy alone, according to the study results.

"We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself," said Robert H. Pierce, Chief Scientific Officer of Ernexa Therapeutics.

ERNA-101 is an allogeneic induced mesenchymal stem cell therapy derived from induced pluripotent stem cells and engineered to target tumors and secrete an IL-7/IL-15 fusion cytokine within the tumor microenvironment. The approach aims to maximize immune activation while minimizing systemic toxicity.

The study findings showed the therapy converted the tumor environment from immunosuppressive to immune-activated, increased activity and persistence of T cells, and enabled more CD4+ and CD8+ T cells to enter tumors. The treatment also reduced tumor burden and decreased ascites fluid accumulation associated with advanced disease.

Ernexa plans to incorporate these findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in patients with advanced ovarian cancer. The company is conducting a clinical proof-of-concept trial in collaboration with MD Anderson Cancer Center in platinum-resistant ovarian cancer.

Ovarian cancer, particularly high-grade serous ovarian carcinoma, has shown limited response to existing treatments including checkpoint inhibitors due to the immunosuppressive tumor microenvironment.