Regulatory2026-07-15

ERNA-101

Ernexa Therapeutics Inc.ERNA
Indication
Triple-negative breast cancer (TNBC) and platinum-resistant, TP53-mutant ovarian cancer
Stage
phase0
Event
Submission
Details

July 15, 2026: Ernexa Therapeutics (NASDAQ: ERNA) reported independent CRO validation of preclinical efficacy for its lead cell therapy candidate ERNA-101 combined with anti-PD-1 therapy in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. In the expanded study, the ERNA-101 + anti-PD-1 arm achieved complete tumor clearance and durable long-term survival in 10/15 animals (67%), while no complete responses or durable survival were observed in any of the other 45 animals receiving ERNA-101 monotherapy, anti-PD-1 monotherapy, or no treatment. The company said the results reproduce earlier findings from The University of Texas MD Anderson Cancer Center and support ERNA-101’s proposed mechanism (tumor homing and delivery of an engineered IL-7/IL-15 fusion cytokine to remodel the tumor microenvironment and increase T-cell infiltration). Upcoming catalysts: IND submission planned for Q3 2026 and initiation of a first-in-human Phase 1 trial expected in Q4 2026.