(RTTNews) - Wednesday, Ernexa Therapeutics (ERNA) reported positive results from three IND-enabling safety studies of ERNA-101, its investigational iMSC therapy for advanced cancers. ERNA-101 is an engineered cell therapy designed to deliver an IL-7/IL-15 fusion cytokine to tumors and is initially being developed for platinum-resistant ovarian cancer. Across repeat-dose toxicology, tumorigenicity and biodistribution studies, ERNA-101 showed no treatment-related adverse findings, no teratoma formation through six months and no significant signal in non-tumor tissues. Ernexa 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.
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