Ernexa Therapeutics completes Pre-IND meeting with FDA

Ernexa Therapeutics (ERNA) announced the completion of its recent Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration. Feedback from the FDA provided strong regulatory alignment on Ernexa’s development approach and set a clear pathway toward submitting the IND and initiating its first-in-human trial for the treatment of ovarian cancer, expected in the second half of 2026. Following the meeting, Ernexa has accelerated key operational activities. Tech transfer – one of the most significant milestones in preparing for clinical manufacturing – is already underway, positioning the company to rapidly advance toward production of clinical-grade material and trial readiness. Ernexa is currently advancing two synthetic, allogeneic induced mesenchymal stem cell therapies – ERNA-101 for ovarian cancer and ERNA-201 for autoimmune disease. Built from reprogrammed induced pluripotent stem cells, Ernexa’s engineered iMSCs are designed to actively home in on tumors or inflamed tissues and deliver potent therapeutic cytokines directly to the disease site. This targeted, off-the-shelf approach aims to overcome key limitations of traditional MSC therapies while enabling scalable manufacturing and broad patient accessibility. The company’s initial clinical development will focus on ERNA-101 for the treatment of ovarian cancer, a disease with limited effective targeted therapies and high recurrence rates.