Ernexa Therapeutics Positioned to Become a Clinical-Stage Biotechnology Company as ERNA-101 On Track for Planned Q3 2026 IND Submission and First-in-Human Study
Lead Cell Therapy Demonstrated Complete Tumor Clearance and 100% Long-Term Survival in Preclinical Ovarian Cancer Models; Multiple Regulatory, Manufacturing and Clinical Catalysts Expected Through 2027
Excerpt from the Press Release:
CAMBRIDGE, Mass., June 17, 2026 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today highlighted significant progress across manufacturing, regulatory and clinical development activities supporting ERNA-101, the Company’s lead oncology candidate.
With manufacturing process development completed, GMP production underway, IND-enabling activities advancing and an Investigational New Drug (IND) submission planned for the third quarter of 2026, Ernexa believes it is well-positioned to initiate its first-in-human Phase 1 clinical study in the fourth quarter of 2026 and transition into a clinical-stage biotechnology company.
“ERNA-101 continues to advance toward the clinic as we execute across manufacturing, regulatory and clinical development activities,” said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. “With GMP manufacturing underway, technology transfer activities progressing and our IND submission expected in the third quarter of 2026, we believe we are entering one of the most important periods in the Company’s history.”
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