Press Releases July 24, 2026 09:20 AM

Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies

Ernexa Therapeutics CEO highlights ERNA-101's potential in combination cancer therapies targeting resistant solid tumors

By Ajmal Hussain
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Ernexa Therapeutics' CEO Sanjeev Luther emphasized the promise of their novel off-the-shelf cell therapy, ERNA-101, designed to modify immunosuppressive tumor microenvironments and serve as a complementary treatment to existing immunotherapies. Preclinical studies demonstrate complete tumor elimination and long-term survival benefits when combined with PD-1 blockade, signaling potential advancement in treating resistant solid tumors like ovarian cancer. The company remains on track for IND submission in Q3 2026, advancing towards clinical trials and commercial targeting of platinum-resistant ovarian cancer.

Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies
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Key Points

  • ERNA-101 is engineered to convert immunologically "cold" tumors into targets for immune system attack, potentially enhancing existing immunotherapy efficacy.
  • Preclinical data shows complete tumor clearance and durable survival when ERNA-101 is combined with PD-1 inhibitors, indicating significant therapeutic potential in ovarian cancer.
  • Ernexa is progressing toward planned IND submission in Q3 2026 and Phase 1 trials, targeting an initial patient population of 15,000 women with platinum-resistant ovarian cancer in the U.S.
  • Sectors impacted include biotechnology, oncology therapeutics, immunotherapy, and advanced cell therapy markets.

CEO Discusses Why the Future of Cancer Treatment May Belong to Combination Approaches and How ERNA-101 Was Designed to Turn Immunologically "Cold" Tumors Into Targets for the Immune System

Video Showcases Differentiated Off-the-Shelf Cell Therapy Platform, Independent Validation of Complete Tumor Clearance in Preclinical Studies and Continued Execution Toward Planned IND Submission in Q3 2026

Access the Ernexa CEO Corner here 

CAMBRIDGE, Mass., July 24, 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, who discusses why many of the next major advances in oncology may come from intelligently combining therapies with complementary mechanisms of action and how Ernexa believes ERNA-101 was intentionally designed to play an important role within that evolving treatment paradigm.

As immunotherapies and antibody-drug conjugates (ADCs) continue transforming cancer treatment, many solid tumors remain resistant because they evade immune detection. In the video, Mr. Luther explains how ERNA-101 was specifically engineered to address one of oncology's most significant remaining challenges, the immunosuppressive tumor microenvironment and why the Company believes its novel off-the-shelf cell therapy has the potential to enhance the effectiveness of existing immunotherapies rather than compete with them.

The discussion also highlights Ernexa's growing body of encouraging preclinical data, differentiated allogeneic induced mesenchymal stem cell (iMSC) platform, and continued operational execution as the Company advances toward becoming a clinical-stage biotechnology company.

“Cancer treatment continues to evolve, but one of the biggest opportunities still lies ahead helping more patients benefit from the therapies that already exist," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "We believe the future of oncology will increasingly rely on combination therapies that attack cancer from multiple angles, and ERNA-101 was intentionally designed to play that role. By targeting the tumor microenvironment and helping activate an immune response within the tumor itself, we believe ERNA-101 has the potential to work alongside today's leading immunotherapies and address one of the biggest remaining challenges in solid tumors. Our CEO Corner provides investors with an inside look at the science supporting this strategy, the compelling preclinical data we've generated, and the meaningful progress we're making as we advance toward our planned IND submission and first-in-human clinical study."

During the CEO Corner, Mr. Luther explains how Ernexa's proprietary allogeneic, off-the-shelf iMSC platform enables ERNA-101 to selectively home to tumors, deliver its therapeutic payload directly within the tumor microenvironment, and potentially convert immunologically "cold" tumors into tumors that can be recognized and attacked by the immune system.

The video also reviews compelling preclinical data supporting this differentiated approach, including:

  • Complete tumor elimination and 100% long-term survival in an initial ovarian cancer study when ERNA-101 was combined with PD-1 blockade.
  • Independent validation demonstrating complete tumor clearance and durable long-term survival in approximately two-thirds of treated animals, while no complete responses were observed in untreated controls or either monotherapy group, reinforcing the potential value of ERNA-101 as a combination therapy.

Mr. Luther also provides investors with an operational update, highlighting that Ernexa has completed manufacturing process development, initiated engineering batch production, continues advancing IND-enabling activities, and remains on track for its planned IND submission in the third quarter of 2026 followed by an anticipated Phase 1 clinical study in the fourth quarter of 2026.

The discussion concludes with Ernexa's commercial strategy, initially targeting the approximately 15,000 women diagnosed annually in the United States with platinum-resistant ovarian cancer, while recognizing the opportunity to potentially expand into the significantly larger platinum-sensitive ovarian cancer population as clinical development progresses.

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.

Media Contact
Sharon Golubchik
RAYNZ
[email protected]

Investor Contact
Jenene Thomas
JTC Team, LLC
(908) 824-0775
[email protected]


Risks

  • ERNA-101 remains in preclinical development, and planned IND submission and clinical trials are yet to be completed, presenting risks inherent in drug development timelines and outcomes.
  • Uncertainty exists around whether preclinical efficacy will translate to human clinical success, including safety and effectiveness in diverse patient populations.
  • Market risks include competition from other emerging immunotherapies and challenges in regulatory approvals impacting biotechnology and cancer treatment sectors.

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