CEO discusses ERNA-101's potential to transform immunologically "cold" tumors into tumors the immune system can recognize and kill
Video highlights compelling preclinical data, differentiated off-the-shelf iMSC platform and progress toward planned first-in-human clinical evaluation
IND submission planned for the third quarter of 2026 with first-in-human Phase 1 study anticipated to begin in the fourth quarter of 2026
Access the Ernexa CEO Corner here
CAMBRIDGE, Mass., July 14, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today released a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther discussing the significant unmet need in ovarian cancer, the Company's differentiated approach with ERNA-101 and Ernexa's progress toward advancing its lead cell therapy candidate into the clinic in the fourth quarter of 2026.
Ovarian cancer remains one of the deadliest cancers affecting women worldwide. While treatment options have improved over time, many patients eventually experience disease recurrence and progression, leaving limited options for women with platinum-resistant ovarian cancer. In the discussion, Mr. Luther explains how the ability of many ovarian tumors to evade immune detection represents one of the greatest scientific challenges in the disease and why ERNA-101 is designed to help overcome this barrier.
"Every ovarian cancer diagnosis impacts far more than a single patient. It affects families, loved ones and futures, which is why we believe there remains an urgent need for new therapeutic approaches," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "At Ernexa, we believe ERNA-101 has the potential to address one of the greatest scientific challenges in ovarian cancer by helping transform immunologically 'cold' tumors into tumors the immune system can recognize. This CEO Corner provides additional insight into the science behind our approach, the encouraging preclinical data supporting ERNA-101 and the progress we are making as we advance toward our planned first-in-human Phase 1 study in the fourth quarter of this year."
The discussion also highlights ERNA-101, Ernexa's lead cell therapy candidate, which is designed to deliver a proprietary immune-activating cytokine directly within the tumor microenvironment with the goal of transforming immunologically "cold" tumors into tumors the immune system can recognize. Mr. Luther also discusses the Company's proprietary off-the-shelf induced mesenchymal stem cell (iMSC) platform, which the Company believes has the potential to improve manufacturing consistency, increase scalability and ultimately make advanced cell therapies more broadly accessible to patients.
The CEO Corner also reviews encouraging preclinical findings demonstrating complete tumor clearance and 100% long-term survival in preclinical ovarian cancer models when ERNA-101 was combined with PD-1 blockade. Mr. Luther also discusses findings demonstrating remodeling of the tumor microenvironment and increased immune cell infiltration, which further support the scientific rationale behind ERNA-101. He concludes by reviewing the Company's ongoing manufacturing, regulatory and clinical development activities as Ernexa advances toward its planned IND submission expected in Q3 2026 and anticipated first-in-human clinical study anticipated to start in Q4 2026.
The Ernexa CEO Corner is now accessible on the Company's website and social media channels. Access it here.
For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com
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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