Full Press Release Details
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the presentation of new preclinical data on its lead cell therapy candidate, ERNA-101, at the American Society of Hematology (ASH) Annual Meeting. The data demonstrated that its proprietary cell therapy platform can rapidly and durably reprogram immunosuppressive tumor microenvironments (TMEs) into immune-active, pro-inflammatory states to combat cancer.
The platform engineers induced pluripotent stem cells (iPSCs) and transforms them into induced mesenchymal stem cells (iMSCs). The preclinical findings underscore the platform’s potential to overcome resistance in both solid tumors and hematologic malignancies and highlight a scalable, off-the-shelf approach to local cytokine delivery.
The abstract titled, ”Gene-modified iPSC-derived MSCs convert immunosuppressive tumor microenvironments (TMEs) into distinct pro-inflammatory TMEs,” was recently presented in an oral presentation by Michael Andreeff, M.D., Ph.D., Professor of Medicine, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and lead author on the study.
“These data represent an important validation of our platform and reinforce our belief that iPSC-derived MSCs can be engineered into powerful immune-modulating agents,” said Sanjeev Luther, President & CEO of Ernexa Therapeutics. “We view this as a platform-level advance that has the potential to support multiple oncology programs, including drug-resistant cancers where immunotherapy has historically underperformed. We believe our ability to manufacture clonal, gene-modified cells at scale gives us a meaningful competitive advantage as we advance toward clinical development.”
“These data highlight the potential of iPSC-derived MSCs and their ability to be repurposed from their historical immunosuppressive roles into highly effective, immune-activating delivery vehicles,” said Dr. Andreeff. “The ability to deliver cytokines directly into tumors and reprogram the immune ecosystem represents a powerful and clinically relevant strategy. We are pleased with these results and look forward to further evaluation to understand the full potential of ERNA-101.”
The preclinical study, conducted in collaboration with investigators at MD Anderson Cancer Center, demonstrated that iMSCs engineered to secrete the cytokines interleukin-7 (IL-7) and interleukin-15 (IL-15) achieved supraphysiologic cytokine production levels that were approximately 20-fold higher than levels previously reported in engineered T-cell approaches. These levels corresponded to robust T-cell expansion and activation, sustained STAT5 signaling, and upregulation of survival pathways critical to immune persistence.
In an immunocompetent ovarian cancer model, intraperitoneal administration of IL-7/IL-15-secreting iMSCs resulted in significant immune cell infiltration into tumors, macrophage polarization toward a pro-inflammatory phenotype, and prolonged survival. Importantly, tumors transitioned from an immune-excluded (“cold”) state to a highly inflamed (“hot”) microenvironment, a key prerequisite for responsiveness to modern immunotherapies.
Ernexa is advancing a best-in-class approach using synthetic, allogeneic iMSCs to provide a scalable, off-the-shelf treatment without needing patient-specific cell harvesting. The Company continues to advance its lead program, ERNA-101, through additional preclinical testing, with first-in-human trials planned for next year.
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.