Ernexa Therapeutics Receives Independent Validation of ERNA-101 with Complete Tumor Clearance and Durable Survival in Ovarian Cancer Models Ahead of Planned Clinical Entry
Independent CRO Successfully Reproduces ERNA-101 Combination Data in Larger Preclinical Study, Significantly Strengthening Confidence as Company Advances Toward IND
ERNA-101 Plus Anti-PD-1 Achieved Complete Tumor Clearance and Long-Term Survival in Two-Thirds of Treated Animals While No Complete Responses Were Observed in Any Monotherapy or Control Group
IND Submission Planned for Q3 2026 with First-in-Human Phase 1 Trial Expected to Begin in Q4 2026
CAMBRIDGE, Mass., July 15, 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 compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition.
The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101's mechanism of action and provide important third-party validation as the Company advances toward its planned Investigational New Drug (IND) submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter.
In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals (67%). Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy.
"This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "Independent reproduction of these findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming IND submission. Perhaps most importantly, complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically 'cold' solid tumors. With IND submission planned this quarter and our first clinical study expected later this year, we believe Ernexa is entering one of the most important value-creating periods in the Company's history."
Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors.
The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone.
"One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "These independently generated results provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate T cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors. Independent confirmation of these findings is particularly meaningful because reproducibility is one of the strongest indicators supporting successful clinical translation. We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically 'cold' solid tumors where today's checkpoint inhibitors have produced limited clinical benefit."
The study was conducted by an independent contract research organization using expanded treatment groups in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. Tumor burden was monitored longitudinally through bioluminescence imaging to evaluate treatment response and confirm complete tumor clearance.
The study included four treatment arms:
- ERNA-101 plus anti-PD-1
- ERNA-101 monotherapy
- Anti-PD-1 monotherapy
- Untreated control
Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade.
With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.
About Ernexa Therapeutics
Ernexa Therapeutics (NASDAQ:ERNA) is developing innovative cell therapies for the treatment of advanced cancer and autoimmune diseases. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, 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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