Ernexa Therapeutics, Inc. (NASDAQ:ERNA) shares are trading higher Wednesday after the company announced preclinical data showing its ERNA-101 cell therapy candidate achieved complete tumor clearance and 100% long-term survival in ovarian cancer models when combined with PD-1 blockade.

• Ernexa Therapeutics shares are powering higher. Why are ERNA shares rallying?

Breakthrough Preclinical Results

Ernexa said the combination therapy significantly outperformed either treatment alone in preclinical ovarian cancer models. According to the company, treatment with ERNA-101 and anti-PD-1 therapy resulted in complete tumor clearance, defined as the loss of detectable tumor signal through bioluminescence imaging, along with 100% survival through long-term follow-up.

"This data represents a significant step forward," said Robert Pierce, chief scientific officer of Ernexa Therapeutics.

Pierce said the findings demonstrated complete tumor eradication and durable survival driven by immune activation within the tumor itself. The company also said ERNA-101 remodeled the tumor microenvironment from immunosuppressive to immune-activated, enabling stronger and more sustained anti-tumor immune responses.

Additional findings from the preclinical studies included increased activity and persistence of cancer-fighting T cells, greater infiltration of CD4+ and CD8+ T cells into tumors, macrophage reprogramming toward a cancer-fighting state and reduced tumor burden and ascites fluid accumulation.

"What we are seeing goes beyond expectations," said Sanjeev Luther, president and CEO of Ernexa Therapeutics.

Luther added that the results reinforced confidence in ERNA-101's ability to enhance checkpoint inhibitor activity and potentially improve outcomes in ovarian cancer and other immunologically "cold" solid tumors.

Ernexa said it plans to incorporate the findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in patients with advanced ovarian cancer. The company added that ongoing studies are evaluating ERNA-101 in combination with checkpoint inhibitors and other immuno-oncology agents.

Ernexa Shares Soar Wednesday

ERNA Price Action: At the time of writing, Ernexa shares are trading 33.32% higher at $5.32, according to data from Benzinga Pro.

This illustration was generated using artificial intelligence via Midjourney.