Ernexa Therapeutics Receives Independent Validation of ERNA-101 with Complete Tumor Clearance and Durable Survival in Ovarian Cancer Models Ahead of Planned Clinical Entry

Ernexa Therapeutics Receives Independent Validation of --> Accessibility: Skip TopNav Ernexa Therapeutics Receives Independent Validation of ERNA-101 with Complete Tumor Clearance and Durable Survival in Ovarian Cancer Models Ahead of Planned Clinical Entry July 15, 2026 07:50 ET | Source: Ernexa Therapeutics Inc. Ernexa Therapeutics Inc. Independent CRO Successfully Reproduces ERNA-101 Combination Data in Larger Preclinical Study, Significantly Strengthening Confidence as Company Advances Toward IND ERNA-101 Plus Anti-PD-1 Achieved Complete Tumor Clearance and Long-Term Survival in Two-Thirds of Treated Animals While No Complete Responses Were Observed in Any Monotherapy or Control Group IND Submission Planned for Q3 2026 with First-in-Human Phase 1 Trial Expected to Begin in Q4 2026 CAMBRIDGE, Mass., July 15, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition. The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101's mechanism of action and provide important third-party validation as the Company advances toward its planned Investigational New Drug (IND) submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter. In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals (67%). Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy. "This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "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. Perhaps most importantly, complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically 'cold' solid tumors. With IND submission planned this quarter and our first clinical study expected later this year, we believe Ernexa is entering one of the most important value-creating periods in the Company's history." Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors. The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone. "One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "These independently generated results provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate T cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors. Independent confirmation of these findings is particularly meaningful because reproducibility is one of the strongest indicators supporting successful clinical translation. We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically 'cold' solid tumors where today's checkpoint inhibitors have produced limited clinical benefit." The study was conducted by an independent contract research organization using expanded treatment groups in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. Tumor burden was monitored longitudinally through bioluminescence imaging to evaluate treatment response and confirm complete tumor clearance. The study included four treatm