Ernexa Therapeutics (Nasdaq: ERNA) reported encouraging results from three core Investigational New Drug (IND) studies for 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 GLP (Good Laboratory Practice) 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. The findings add to previously reported complete tumor clearance and durable survival in preclinical ovarian cancer models when ERNA-101 was combined with PD-1 blockade. Ernexa said its core safety studies are complete, GMP manufacturing is underway and it remains on track to submit an IND to the FDA (U.S. drug regulator) in the fourth quarter of 2026 for a first-in-human study in platinum-resistant ovarian cancer. Subject to IND clearance, the company intends to dose the first patient, with initial clinical data currently expected in the fourth quarter of 2027.