Regulatory2026-09-30

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 14, 2026: Ernexa Therapeutics (NASDAQ: ERNA) released a CEO Corner video update on ERNA-101, its lead allogeneic induced mesenchymal stem cell (iMSC)–based cell therapy program being developed initially for ovarian cancer, including platinum-resistant disease. The company says ERNA-101 is designed to deliver a proprietary immune-activating cytokine within the tumor microenvironment to help convert immunologically “cold” tumors into tumors the immune system can recognize, and highlighted its off-the-shelf iMSC platform.

The update cites preclinical ovarian cancer model findings where ERNA-101 combined with PD-1 blockade showed complete tumor clearance and 100% long-term survival, along with tumor microenvironment remodeling and increased immune cell infiltration.

Upcoming catalysts: Ernexa expects to submit an IND for ERNA-101 in Q3 2026 and anticipates initiating a first-in-human Phase 1 study in Q4 2026.