Ernexa Therapeutics (Nasdaq: ERNA) announced preclinical data from an independently conducted study showing complete tumor clearance and long-term survival in two-thirds of animals treated with its lead cell therapy candidate, ERNA-101, combined with anti-PD-1 therapy in an ovarian cancer model.

The study, conducted by an independent contract research organization, used an immunocompetent ID8luc-ova syngeneic ovarian cancer model with four treatment arms. Complete tumor clearance and durable survival were observed in 10 of 15 animals receiving the combination therapy. No complete responses were recorded in animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated.

The independent study reproduced earlier findings generated at The University of Texas MD Anderson Cancer Center. Tumor burden was monitored through bioluminescence imaging across the study period.

"Independent reproduction of these findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming IND submission," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.

Robert H. Pierce, M.D., Chief Scientific Officer, said the results provide validation that ERNA-101 may remodel the tumor microenvironment and enhance the activity of PD-1 checkpoint inhibitors.

Ernexa said it plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration in the third quarter of 2026, with a first-in-human Phase 1 clinical trial expected to begin in the fourth quarter of 2026.

ERNA-101 is designed using induced pluripotent stem cells engineered into induced mesenchymal stem cells that deliver an IL-7/IL-15 fusion cytokine into the tumor microenvironment. The company's initial clinical focus is ovarian cancer.