Ernexa targets Q4 2026 IND filing for first-in-human ERNA-101 trial in platinum-resistant ovarian cancer
ERNA•Ernexa reported preclinical safety results for ERNA-101 supporting a planned IND filing in Q4 2026. The company expects initial clinical data from a first-in-human study in platinum-resistant ovarian cancer in Q4 2027.
1. Preclinical safety results
Ernexa reported results from repeat-dose toxicology, tumorigenicity, biodistribution and single-dose cytokine release assessments for ERNA-101. The studies found no treatment-related safety findings or evidence of acute cytokine release in the single-dose evaluation.
2. Development timeline
Tumorigenicity testing showed no teratoma formation through a six-month in-life phase, while final pathology review remains in progress. Ernexa plans to file an IND in Q4 2026 and expects initial clinical data from its planned first-in-human study in platinum-resistant ovarian cancer in Q4 2027.
