Ernexa Therapeutics (Nasdaq: ERNA) said it is on track to submit an Investigational New Drug application for its lead oncology candidate, ERNA-101, in the third quarter of 2026, with a first-in-human Phase 1 clinical study targeted to begin in the fourth quarter of 2026.

The Cambridge, Mass.-based company said it has completed manufacturing process development for ERNA-101 and has begun good manufacturing practice production for clinical supply. Technology transfer activities to support future manufacturing scalability are also underway.

ERNA-101 is an allogeneic cell therapy derived from induced pluripotent stem cells and engineered to deliver an IL-7/IL-15 fusion cytokine into the tumor microenvironment. The company's initial target indication is platinum-resistant ovarian cancer.

In preclinical ovarian cancer models, ERNA-101 combined with PD-1 blockade showed complete tumor elimination and 100% long-term survival through study follow-up, according to the company. The studies also showed increased T-cell infiltration and remodeling of the tumor microenvironment.

Ernexa said it expects to release its first GMP clinical product batch and complete required IND-enabling studies in the third quarter of 2026. First patient enrollment is planned for the fourth quarter of 2026, with initial Phase 1 clinical data expected in the first half of 2027.

The company said it completed a $10.5 million financing and believes it has sufficient resources to support its near-term development plans. A pre-IND meeting with the FDA for its ERNA-201 autoimmune disease program is also planned for the fourth quarter of 2026.

"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," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.