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

Aug. 10, 2026: Ernexa Therapeutics (NASDAQ: ERNA) announced the appointment of David Polinsky to its Board of Directors, a corporate governance update tied to upcoming development milestones for its lead cell therapy program, ERNA-101.

The company said it is positioning ERNA-101 for a planned IND submission in Q3 2026 and initiation of its first Phase 1 clinical study in Q4 2026. ERNA-101 is being developed initially for ovarian cancer and is described as a cell therapy designed to activate and regulate the immune system to recognize and attack cancer cells.

The release states Ernexa has been generating preclinical data, advancing manufacturing, preparing the IND submission, and building clinical-stage operational infrastructure. No clinical data or regulatory decisions were disclosed.

Polinsky was described as a biotech founder, public company CFO, and corporate attorney with more than 25 years of experience in oncology, capital markets, M&A, financing, licensing, and governance. The company framed the appointment as support for its transition into a clinical-stage biotechnology company.