CAMBRIDGE, Mass. — May 6, 2026 — Leads & Copy — Ernexa Therapeutics (Nasdaq: ERNA) announced new preclinical data today showing its lead cell therapy candidate, ERNA-101, combined with PD-1 blockade, leads to complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.
The company, which develops cell therapies for advanced cancer and autoimmune diseases, said the treatment outcomes significantly exceeded those observed with either therapy alone, suggesting potential curative activity.
According to Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics, the data represents a significant step forward. He said the company is seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself.
The data further demonstrates that ERNA-101 remodels the tumor microenvironment (TME) from immunosuppressive to immune-activated, enabling robust and sustained anti-tumor immune responses.
The findings, Pierce said, underscore the potential of ERNA-101 to overcome one of the biggest challenges in ovarian cancer – an immunologically ‘cold’ TME – and to unlock the full potential of checkpoint inhibition. Subsequent to a positive clinical proof-of-concept trial in collaboration with the MD Anderson Cancer Center in platinum-resistant ovarian cancer, the company anticipates broadening the scope of indications to include other solid tumors, where strong immunosuppression in the tumor microenvironment limits the clinical benefit of anti-PD-1 therapy.
In the study, treatment with ERNA-101 in combination with anti-PD-1 therapy resulted in complete tumor clearance (i.e., loss of detectable tumor signal by bioluminescence imaging) and 100% survival through long-term follow-up.
Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics, said that the results give the company increased confidence in ERNA-101’s ability to meaningfully enhance the activity of checkpoint inhibitors and potentially shift treatment outcomes in ovarian cancer.
Luther added that this approach may also extend beyond ovarian cancer, with the potential to drive meaningful responses across other immunologically ‘cold’ solid tumors characterized by highly suppressive tumor microenvironments. He said the company believes ERNA-101 has the potential to become a foundational therapy in combination regimens, significantly expanding treatment effectiveness.
ERNA-101 is an allogeneic induced mesenchymal stem cell (iMSC) therapy derived from induced pluripotent stem cells (iPSCs) and engineered to home to tumors and secrete a potent IL-7/IL-15 fusion cytokine directly within the TME. This localized cytokine delivery approach is designed to maximize immune activation while minimizing systemic toxicity.
Key findings from the preclinical studies include:
- Complete tumor clearance and survival: Combination therapy eliminated detectable tumors and achieved 100% survival in treated mice through long-term follow-up
- Tumor microenvironment remodeling: ERNA-101 converted the tumor environment from immunosuppressive to immune-activated, enabling stronger immune attack on the tumor
- Enhanced immune cell activity: Treatment increased the activity, survival, and persistence of key cancer-fighting T cells
- Immune infiltration: Significantly more CD4⁺ and CD8⁺ T cells were able to enter tumors and engage cancer cells directly
- Macrophage reprogramming: Immune cells within the tumor shifted toward a cancer-fighting state rather than a tumor-supporting state
- Reduced disease burden: Treatment reduced tumor burden and decreased ascites fluid accumulation associated with advanced disease
Ernexa plans to incorporate these findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in patients with advanced ovarian cancer. Ongoing studies are evaluating ERNA-101 in combination with checkpoint inhibitors and other immuno-oncology agents.
Ovarian cancer, particularly high-grade serous ovarian carcinoma (HGSOC), remains a significant unmet medical need, with most patients diagnosed at advanced stages and high relapse rates following standard therapies. Existing treatments, including checkpoint inhibitors, have shown limited efficacy due to the highly immunosuppressive TME.
ERNA-201 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer.
For more information, visit www.ernexatx.com.
Source: Ernexa Therapeutics
