(RTTNews) - Ernexa Therapeutics (ERNA) said it is preparing to transition into a clinical-stage biotechnology company as its lead oncology candidate, ERNA-101, moves toward a planned IND submission in the third quarter of 2026. With manufacturing development completed and GMP production underway, the company expects to begin its first-in-human Phase 1 study in the fourth quarter of 2026, following a successful FDA pre-IND meeting.
ERNA-101 is an engineered, allogeneic induced mesenchymal stem cell (iMSC) therapy designed to home to tumors while delivering a proprietary IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. The approach aims to activate T cells and natural killer cells to help the immune system recognize and attack "cold" tumors that typically evade current treatments.
Ernexa reported that several key operational steps have been completed, including technology transfer activities, advancement of IND-enabling studies, and preparation of regulatory documentation needed for submission. These efforts support the company's plan to maintain its IND timeline and initiate clinical evaluation later this year.
Preclinical studies showed encouraging results, with ERNA-101 combined with PD-1 blockade achieving complete tumor elimination, 100% long-term survival, and significant remodeling of the tumor microenvironment in ovarian cancer models. The therapy also increased T-cell infiltration and reprogrammed tumor-associated macrophages, supporting its potential as a complementary immunotherapy approach for difficult-to-treat solid tumors.
The company said it remains well-funded following a recent $10.5 million financing, which it believes will support near-term development plans and multiple milestones expected through 2027.
Key upcoming milestones include:
•Q3 2026: Release of first GMP batch, completion of IND-enabling studies, IND submission for ERNA-101.
•Q4 2026: FDA review and initiation of the first-in-human Phase 1 study in platinum-resistant ovarian cancer, Pre-IND meeting with the FDA for ERNA-201 autoimmune disease program.
•2027: Initial Phase 1 data and potential advancement into Phase 2 development, along with strategic partnership opportunities and expansion into other solid tumor indications.
CEO Sanjeev Luther said the upcoming clinical transition marks one of the most important periods in the company's history, noting the potential for ERNA-101 to reshape treatment options for patients with immunologically cold tumors.
The company recently implemented a 1-for-25 reverse stock split on May 4, 2026.
ERNA currently trading at $6.28, up 2.95%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
