Ernexa Therapeutics (Nasdaq: ERNA) reported encouraging results from three core Investigational New Drug (IND)-enabling studies of ERNA-101, its lead synthetic, allogeneic induced mesenchymal stromal cell (iMSC) therapy engineered to express an IL-7/IL-15 fusion cytokine. A 50-day Good Laboratory Practice (GLP) repeat-dose toxicology study found no ERNA-101-related adverse findings across tested doses, including no clinical pathology or histopathology findings, while a single-dose assessment found no evidence of acute cytokine release. No teratomas were observed through the six-month tumorigenicity in-life phase, and biodistribution testing found no significant ERNA-101 signal in tumor-free animals or non-tumor tissues. Ernexa said the results add safety data to earlier preclinical findings in which ERNA-101 combined with PD-1 blockade produced complete tumor clearance and durable survival in ovarian cancer models. The company said its core safety studies are complete, GMP manufacturing is underway and it remains on track to submit an IND to the FDA in the fourth quarter of 2026 for a first-in-human study in platinum-resistant ovarian cancer. Subject to IND clearance, Ernexa intends to dose the first patient, with initial clinical data currently expected in the fourth quarter of 2027. President and CEO Sanjeev Luther is also scheduled to present the ERNA-101 strategy and Ernexa’s synthetic iMSC platform at the 2026 Cell & Gene Meeting on the Mesa, October 5–7 in Mesa, Arizona.