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Ernexa Therapeutics Validates ERNA-101 Anti-Tumor Activity with PD-1 Inhibition

Ernexa Therapeutics announced 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 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. 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. 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. Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade. With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.

Ernexa Therapeutics Advances ERNA-101 Development, Plans IND Submission in 2026

Ernexa Therapeutics announced progress in the development of ERNA-101, the company's therapeutic candidate, achieving multiple milestones that position the program for a planned investigational new drug submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study. The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice, or GMP, manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline. IND submission for ERNA-101 targeted for Q3.