Ernexa Therapeutics Announces Successful Pre-IND FDA Meeting and Continues Progress Toward First-in-Human Trial in Ovarian Cancer

Core Insights - Ernexa Therapeutics is on track to initiate its first-in-human trial for ovarian cancer treatment in the second half of 2026 following a successful Pre-IND meeting with the FDA, which provided strong regulatory alignment and a clear pathway for IND submission [1][3] Group 1: Company Developments - The company has accelerated key operational activities post-FDA meeting, with tech transfer already underway to prepare for clinical manufacturing and trial readiness [2] - Ernexa is advancing two synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapies: ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease, utilizing reprogrammed induced pluripotent stem cells (iPSCs) [3][5] - The initial clinical development will focus on ERNA-101, targeting ovarian cancer, which currently has limited effective therapies and high recurrence rates [4][6] Group 2: Technology and Approach - Ernexa's engineered iMSCs are designed to target tumors or inflamed tissues, delivering therapeutic cytokines directly to the disease site, which aims to overcome limitations of traditional MSC therapies while enabling scalable manufacturing [3][5] - The company's approach provides an off-the-shelf treatment option without the need for patient-specific cell harvesting, enhancing patient accessibility [5][6]