Ernexa Therapeutics Announces Encouraging Results From Three Core IND-Enabling Safety Studies Of ERNA-101, Lead Synthetic, Allogeneic iMSC Therapy Engineered To Express IL-7/IL-15 Fusion Cytokine

Repeat-dose GLP toxicology study showed no ERNA-101-related adverse findings across all dose levels tested, including no clinical pathology or histopathology findings; single-dose assessment showed no evidence of acute cytokine releaseNo teratoma formation observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing a fundamental safety consideration for an iPSC-derived cell therapyBiodistribution study showed no significant ERNA-101 signal in tumor-free animals or non-tumor tissues, supporting ERNA-101’s tumor-homing delivery strategyEncouraging safety results build on previously reported complete tumor clearance and durable survival in ovarian cancer models, strengthening the nonclinical foundation for ERNA-101Core IND-enabling safety studies complete; GMP manufacturing underway; Company remains on track for planned Q4 2026 IND submissionCAMBRIDGE, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (NASDAQ:ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, today announced highly encouraging results from three core Investigational New Drug (IND)-enabling safety studies of ERNA-101, its lead synthetic, allogeneic induced mesenchymal stromal cell (iMSC) therapy engineered to express an IL-7/IL-15 fusion cytokine.Across repeat-dose GLP toxicology, tumorigenicity and biodistribution studies, ERNA-101 demonstrated a favorable nonclinical safety profile, with results addressing three critical questions as the Company prepares to advance the program toward first-in-human development:Repeat-dose safety: No ERNA-101-related adverse findings were observed at any dose level tested in a 50-day GLP toxicology study in tumor-bearing mice with an intact immune system.Tumorigenicity: No teratoma formation was observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing an important safety consideration for an iPSC-derived therapy.Biodistribution: No significant ERNA-101 signal was detected in tumor-free animals or non-tumor tissues, supporting ERNA-101’s design to home to tumors without taking up residence elsewhere in the body. Importantly, the results add a critical safety dimension to previously reported ERNA-101 efficacy data demonstrating complete tumor clearance and durable long-term survival in preclinical ovarian cancer models when combined with PD-1 blockade. Together, Ernexa believes the efficacy, safety and biodistribution findings provide an increasingly comprehensive nonclinical foundation for advancing ERNA-101 toward the clinic.