Ernexa Therapeutics (NASDAQ:ERNA) shares surged 30% on Wednesday after the company announced positive independent preclinical data supporting its lead cell therapy candidate, ERNA-101, for the treatment of ovarian cancer.
Independent research confirms earlier findings
The company said an independent contract research organisation successfully replicated previous results, demonstrating complete tumour clearance and extended survival in a larger preclinical study.
When ERNA-101 was combined with anti-PD-1 therapy, 10 of the 15 treated animals, or 67%, achieved complete tumour clearance and long-term survival.
By comparison, none of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 therapy alone or left untreated experienced complete tumour elimination or durable survival.
Data supports upcoming clinical development
The latest results independently confirmed earlier research conducted at The University of Texas MD Anderson Cancer Center.
Ernexa said the findings provide additional validation as it prepares to submit its Investigational New Drug (IND) application during the third quarter of 2026.
The company expects to begin its first Phase 1 clinical trial in humans during the fourth quarter of 2026.
Therapy targets the tumour microenvironment
The study used an immunocompetent ID8luc-ova syngeneic ovarian cancer model, with tumour progression monitored using bioluminescence imaging to evaluate treatment response and verify complete tumour clearance.
Previous research showed that ERNA-101 selectively targets ovarian tumours, delivering its engineered IL-7/IL-15 fusion cytokine directly into the tumour microenvironment.
According to the company, this targeted immune activation increases the number of cancer-fighting T cells within tumours that would otherwise evade detection by the immune system.
Focus remains on advanced cancer therapies
Ernexa Therapeutics is developing cell-based therapies for advanced cancers and autoimmune diseases, with ERNA-101 representing its lead oncology programme.
The latest independent validation marks another milestone as the company advances the therapy toward clinical testing.