Preclinical data demonstrate deep and durable tumor regressions with lead product candidate ERNA-101 in combination with PD-1 Blockade in ovarian cancer
IND submission for ERNA-101 expected in Q3 2026 with first-in-human study planned for Q4 2026 for the treatment of platinum-resistant ovarian cancer
Multiple regulatory and clinical milestones expected to drive significant value creation over the next 12-18 months
CAMBRIDGE, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today provided a business update highlighting the Company’s accelerating transition toward clinical development and a series of upcoming milestones expected to serve as key value-inflection points over the next 12-18 months.
Following significant scientific, regulatory and operational progress, Ernexa is entering a pivotal execution phase as it advances its lead program, ERNA-101, toward a first-in-human clinical trial expected to begin in Q4 2026 for the treatment of platinum-resistant ovarian cancer. The Company is currently completing the final steps required to support an Investigational New Drug (IND) submission in Q3 2026.
ERNA-101 is an engineered synthetic induced-mesenchymal stem cell (iMSC) therapy designed to deliver immune-activating cytokines directly to the tumor microenvironment, with the goal of converting immunologically “cold” tumors into immune-responsive tumors. Recent preclinical data further strengthen the rationale for ERNA-101 as a potential treatment for ovarian cancer. In a syngeneic ovarian cancer model, the combination of an anti-PD-1 mAb plus ERNA-101 demonstrated durable antitumor activity, including high rates of complete tumor regressions, significantly prolonged survival. When combined with PD-1 blockade, ERNA-101 produced markedly enhanced responses compared with either agent alone, supporting its potential to convert immunologically “cold” tumors into responsive tumors and reinforcing the Company’s confidence as the program advances toward first-in-human clinical studies.
- Key Highlights
- Combination drives high rates of complete tumor regressions and significantly extended survival in aggressive ovarian cancer model, supporting ERNA-101 as a potential foundational immunotherapy platform
- Company on track to commence first-in-human clinical trials of ERNA-101 in ovarian cancer in Q4 2026
“The coming year represents a transformative period for Ernexa as we transition from a preclinical organization into a clinical-stage biotechnology company,” commented Sanjeev Luther, President and CEO of Ernexa Therapeutics. “With an IND submission for ERNA-101 and our first-in-human study anticipated this year, we are approaching multiple important inflection points that we believe can unlock significant value while advancing a novel cell therapy platform designed to address cancers and autoimmune diseases with high unmet medical need.”
In parallel with the advancement of ERNA-101, Ernexa continues to develop ERNA-201, an engineered anti-inflammatory iMSC therapy designed to deliver IL-10 directly to inflamed tissues for the treatment of autoimmune diseases, including rheumatoid arthritis.
Recent Achievements
- 2025 – Completed
- Streamlined operations to reduce general and administrative expenses by approximately 61% year over year, while maintaining focus on advancing core programs
- Completed Proof of Principle (PoP) studies for ERNA-101 and ERNA-201
- Successfully completed Pre-IND meeting with the FDA for ERNA-101
Near-Term Milestones Expected to Drive Value
Ernexa expects the following operational, regulatory and clinical milestones to serve as key catalysts as the Company advances toward clinical development. Supported by a recent $10.5 million financing, the Company is well-positioned to achieve several key value inflection points.
- Upcoming Milestones
- Q2/Q3 2026: Completion of ERNA-101 clinical manufacturing process development in Q2 2026, followed by release of the first product batch in Q3 2026
- Q3 2026: Completion of required IND-enabling preclinical studies for ERNA-101
- Q3 2026: Submission of Investigational New Drug (IND) application for ERNA-101
- Q4 2026: Initiation of first-in-human Phase 1 clinical study of ERNA-101 for treatment of platinum-resistant ovarian cancer
- Q4 2026: Pre-IND meeting with the FDA for ERNA-201
- 1H 2027: Initial clinical data readout from ERNA-101
- 2H 2027: Advancement into Phase 2 trials with a potential co-development partner
- Continue to present data at upcoming leading scientific conferences
“These upcoming milestones represent a clear pathway toward clinical validation of our platform and the potential expansion of our programs into broader oncology and autoimmune indications,” Luther added. “We believe our engineered iMSC platform has the potential to deliver targeted cytokine therapies directly to sites of disease, opening the door to a new class of cell-based therapeutics.”
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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