Regulatory2026-10-06

ERNA-101

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

October 6, 2026: Ernexa Therapeutics (NASDAQ: ERNA) said new preclinical data for ERNA-101 were selected for a Flash Talk at the Next-Generation Cancer Therapeutics meeting in Houston, held October 6–8, 2026. ERNA-101 is an allogeneic, off-the-shelf iPSC-derived mesenchymal stromal cell therapy engineered to express an IL-7/IL-15 fusion protein, being advanced for ovarian cancer.

In preclinical high-grade serous ovarian cancer models, ERNA-101 recruited T cells and proinflammatory macrophages, promoted an immune-active tumor microenvironment, and was associated with significant tumor regression and improved survival. In combination with PD-1 checkpoint blockade, ERNA-101 achieved enhanced antitumor activity, including complete tumor control and durable responses in the majority of treated animals; the company said these findings were reproduced in a larger cohort. Biodistribution studies showed localization to the tumor microenvironment with no detectable signal in peritoneal wash, serum, or other evaluated organs.

Upcoming catalysts mentioned: planned FDA IND submission for ERNA-101 in Q4 2026 and expected first-in-human clinical data in platinum-resistant ovarian cancer in Q4 2027.