Ernexa Therapeutics Unveils Breakthrough Preclinical Results: ERNA-101 Achieves 100% Survival and Complete Tumor Elimination in Ovarian Cancer Models

Landmark data positions ERNA-101 as a potential game-changing immunotherapy and a major catalyst for future clinical and shareholder value

CAMBRIDGE, Mass., May 06, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.

“This data represents a significant step forward,” said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. “We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself. These findings 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, we anticipate 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. These outcomes significantly exceeded those observed with either therapy alone and suggest potential curative activity.

The data further demonstrate that ERNA-101 remodels the TME from immunosuppressive to immune-activated, enabling robust and sustained anti-tumor immune responses.

“What we are seeing goes beyond expectations. Achieving complete tumor elimination and 100% survival in a model where current approaches typically fall short reinforces both the strength of the data and the underlying mechanism driving this response. These results give us increased confidence in ERNA-101’s ability to meaningfully enhance the activity of checkpoint inhibitors and potentially shift treatment outcomes in ovarian cancer. 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. We believe ERNA-101 has the potential to become a foundational therapy in combination regimens, significantly expanding treatment effectiveness,” said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.

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

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.

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.

About Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative stem cell therapies for the treatment of advanced cancer and autoimmune disease. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s synthetic, allogeneic iMSCs provide a scalable, off-the-shelf treatment, without needing patient-specific cell harvesting.

ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells. 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. Forward-looking statements are based upon Ernexa's current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa's risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.

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