ERNA-101 / Ernexa Therapeutics, Factor Bioscience - LARVOL DELTA

Ernexa is prioritizing the next major milestone in the Company's evolution: advancing ERNA-101 toward a planned IND submission for a first-in-human clinical study in platinum-resistant ovarian cancer (GlobeNewswire) - "The Company is focused on advancing ERNA-101 toward a planned IND submission in the fourth quarter of 2026.....Clinical data from the ERNA-101 PROC study are expected in Q4 2027, providing the Company with a series of potential clinical and operational milestones over the coming 12–18 months."

Clinical data • First-in-human • IND • Platinum resistant • Ovarian Cancer

Ernexa Therapeutics CEO Corner Emphasizes How ERNA-101 Could Help Unlock the Next Generation of Combination Cancer Therapies (GlobeNewswire) - "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....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..."

Platinum resistant • Preclinical • Ovarian Cancer

Ernexa Therapeutics CEO Corner Highlights Differentiated ERNA-101 Platform as Company Advances Toward Planned First-in-Human Phase 1 Study in 2026 (GlobeNewswire) - "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...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."

First-in-human • IND • New P1 trial • Platinum resistant • Ovarian Cancer

Expected 2027 Milestones (GlobeNewswire) - "First Half 2027: (i) Initial clinical data from ERNA-101 Phase 1 study; Second Half 2027: (i) Potential advancement into Phase 2 development; (ii) Potential strategic partnership opportunities; (iii) Potential expansion into additional solid tumor indications."

New P2 trial • P1 data • Pipeline update • Platinum resistant • Ovarian Cancer • Solid Tumor

Ernexa Therapeutics Positioned to Become a Clinical-Stage Biotechnology Company as ERNA-101 On Track for Planned Q3 2026 IND Submission and First-in-Human Study (GlobeNewswire) - "Expected 2026 Milestones: Q3 2026: (i) Release of first GMP clinical product batch; (ii) Completion of required IND-enabling studies; (iii) Submission of IND application for ERNA-101; Q4 2026: (i) FDA review of IND application; (ii) Initiation of first-in-human Phase 1 clinical study; (iii) First patient enrollment in platinum-resistant ovarian cancer; (iv) Pre-IND meeting with FDA for ERNA-201 autoimmune disease program."

FDA event • First-in-human • IND • New P1 trial • Platinum resistant • Preclinical • Immunology • Ovarian Cancer

IL7-IL15 fusion cytokine (fusokine)–secreting iPSC-derived mesenchymal stromal cells to convert immunosuppressive into highly immune-activated tumor microenvironments (TMEs), potentiate antitumor immunity, and synergize with PD-1 inhibition in ovarian cancer. (ASCO 2026) - "These data establish IL7/IL15-iMSCs as a novel, immunologically active stromal cell platform capable of remodeling the TME and amplifying both innate and adaptive anti-tumor responses. IL7-IL15 iMSC convert an immune-suppressive into an highly immune-activated TME in diverse tumor types. Combination of IL7/IL15 iMSC with PD1 mAB resulted in apparent cures in the ID8 ovarian cancer model.."

Biomarker • IO biomarker • Stroma • Tumor microenvironment • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • IL15 • IL2RA • IL7 • ISG20 • PD-1

Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development (GlobeNewswire) - "Key Highlights: IND submission for ERNA-101 targeted for Q3 2026; Technology transfer activities currently in progress; Process development for ERNA-101 manufacturing successfully completed; Transition to GMP manufacturing underway in preparation for clinical studies; Company advancing toward anticipated transformation into a clinical-stage biotechnology company; Progress supports planned first-in-human clinical study following IND clearance."

Commercial • First-in-human • IND • New trial • Ovarian Cancer

Ernexa Therapeutics Releases Virtual Investor KOL Connect Segment Featuring Dr. Elena Ratner Highlighting Ovarian Cancer Landscape and ERNA-101 Opportunity (The Manila Times) - "The segment highlights Ernexa’s lead product candidate, ERNA-101, and recently announced preclinical data demonstrating complete tumor elimination and 100% long-term survival in ovarian cancer models when combined with PD-1 blockade...The discussion also highlights the potential advantages of Ernexa’s engineered allogeneic induced mesenchymal stem cell (iMSC) platform, including the opportunity to develop scalable, off-the-shelf cell therapies designed to improve accessibility and overcome manufacturing challenges associated with traditional autologous approaches."

Preclinical • Ovarian Cancer

Ernexa Therapeutics Participates in Virtual Investor "What This Means” Segment Highlighting Recent Successful Pre-IND Meeting with U.S. FDA (The Manila Times) - "As part of the segment, Sanjeev Luther, President & CEO of Ernexa, highlighted how regulatory alignment from the FDA on Ernexa’s development strategy for its lead cell therapy, ERNA-101, provides a clear pathway toward submitting an Investigational New Drug application and initiating clinical testing in the second half of 2026."

IND • Ovarian Cancer

Ernexa Therapeutics Announces Successful Pre-IND FDA Meeting and Continues Progress Toward First-in-Human Trial in Ovarian Cancer (GlobeNewswire) - "Feedback from the FDA provided strong regulatory alignment on Ernexa’s development approach and set a clear pathway toward submitting the IND and initiating its first-in-human (FIH) trial for the treatment of ovarian cancer, expected in the second half of 2026....The company’s initial clinical development will focus on ERNA-101 for the treatment of ovarian cancer, a disease with limited effective targeted therapies and high recurrence rates."

FDA event • First-in-human • IND • Ovarian Cancer

Ernexa Therapeutics Presents New Preclinical Data at American Society of Hematology (ASH) Annual Meeting on Lead Cell Therapy Candidate for Treatment of Ovarian Cancer (GlobeNewswire) - "The preclinical study...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....The Company continues to advance its lead program, ERNA-101, through additional preclinical testing, with first-in-human trials planned for next year....Positive results of ERNA-101 in ovarian cancer models demonstrated promising survival benefit and immune activation, underscoring the potential for broad oncology applications, including hematologic malignancies."

First-in-human • New trial • Preclinical • Hematological Malignancies • Ovarian Cancer

Development Program Highlights: ERNA-101 (GlobeNewswire) - "Leverages MSCs' tumor-homing ability to deliver pro-inflammatory cytokines (IL-7/IL-15) directly to the tumor, enhancing T-cell anti-tumor activity while minimizing systemic toxicity; Demonstrated promising preclinical results with 58.2% survival advantage; Expecting to complete Investigational New Drug (IND) enabling studies and submit an IND for its Phase 1 study in PROC by Q1 2026."

IND • Platinum resistant • Preclinical • Ovarian Cancer

Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer (PRNewswire)

Commercial • Ovarian Cancer

Ernexa Therapeutics to Present New Data in Oral Presentation at AACR Special Conference in Cancer Research (GlobeNewswire) - "Presentation to highlight preclinical data from the company’s lead cell therapy, ERNA-101, demonstrating potential to reprogram the ovarian tumor microenvironment and advance toward clinical trials."

Preclinical • Ovarian Cancer

ASCO: Ernexa's 'Trojan Horse' stem cell therapy shrinks ovarian tumors in mice (FierceBiotech) - "Ernexa Therapeutics’ 'Trojan Horse' stem cells can infiltrate ovarian tumors in mice, boosting T cell activity and leading to shrunken tumors and improved survival, the company announced in a June 2 presentation at the American Society of Clinical Oncology Annual Meeting in Chicago.....The cell therapy, called ERNA-101, stems from work pioneered by oncologist Michael Andreeff, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center. Ernexa plans to bring ERNA-101 into the clinic in 2026."

New trial • Preclinical • Ovarian Cancer

Ernexa Therapeutics Establishes Texas Subsidiary to Support Continued Development of ERNA-101 and Future Clinical Operations (GlobeNewswire) - "Ernexa Therapeutics...today announced the formation of ErnexaTX2, a wholly owned subsidiary based in Texas. The new entity has been established to support ongoing preclinical development of the company’s lead program, ERNA-101 for ovarian cancer, and to lay the operational groundwork for anticipated clinical activity in 2026....ERNA-101 remains on track for IND-enabling studies in 2025, with first-in-human studies targeted for 2026."

New trial • Preclinical • Ovarian Cancer

Ernexa Therapeutics Presented Promising Data on Innovative Cell Therapy Treatment at AACR Annual Meeting 2025 (GlobeNewswire) - "In this study using mice with ovarian cancer, the iMSCs significantly slowed tumor growth and improved survival rates. The treatment led to a greater presence of immune cells in the tumor, including T cells, natural killer (NK) cells, and macrophages – all key players in the body’s defense against cancer. In additional tests, the iMSCs also helped T cells grow and multiply, even in cases of drug-resistant cancer cells....Overall, the study demonstrated significant promise for ERNA-101 as a more effective, accessible, and scalable treatment for patients in the future."

Preclinical • Ovarian Cancer

Ernexa Therapeutics Announces New Data to be Presented at AACR Annual Meeting 2025 (GlobeNewswire) - "Ernexa Therapeutics...today announced that new data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago."

Clinical data • Ovarian Cancer

Eterna Therapeutics Changes Name to Ernexa Therapeutics to Reflect New Strategic Focus on Ovarian Cancer and Autoimmune Disease (GlobeNewswire) - "Eterna Therapeutics...announced the company’s new name: Ernexa Therapeutics...The new name reflects the company’s laser-focused mission and ambitious vision...Ernexa has two cell therapy products in development, which are undergoing preclinical trials. Its lead cell therapy product, ERNA-101, is engineered to enhance and regulate the immune system’s response, enabling it to identify and eliminate cancer cells. ERNA-102 is designed to combat inflammation and treat autoimmune disease....Ernexa’s ticker symbol will remain as ERNA."

Commercial • Immunology • Ovarian Cancer • Rheumatoid Arthritis

Eterna Therapeutics Announces Positive Preclinical Study Results on Lead Product ERNA-101 in Ovarian Cancer (GlobeNewswire) - "This successful proof-of-concept study demonstrated massive T cell infiltration after only one dose of ERNA-101, reduced tumor burden, and extended survival in mice with ovarian cancer....ERNA-101 is a cell therapy that utilizes induced pluripotent stem cells (iPSCs) to create induced allogenic mesenchymal stem cells (iMSCs) that secrete interleukins IL-7 and IL-15. These cytokines enhance the immune system's response against tumors, improving immune cell infiltration and activation."

Preclinical • Gynecologic Cancers • Ovarian Cancer

Eterna Therapeutics Launches Research to Evaluate its Lead Induced Mesenchymal Stem Cell Therapy Candidate’s (ERNA-101) Ability to Induce and Modulate Antitumor Immunity in Ovarian Cancer and Breast Cancer Models (GlobeNewswire) - "Eterna Therapeutics...today announced it will investigate the ability of its lead iMSC-based cell therapy (ERNA-101) to induce and modulate antitumor immunity in ovarian cancer and breast cancer models through a sponsored research agreement with The University of Texas MD Anderson Cancer Center....Researchers will investigate immunomodulatory effects of ERNA-101 in vitro and antitumor immunity of ERNA-101 in ovarian cancer and breast cancer models in vivo. Based on results from these studies, future research may evaluate ERNA-101 combined with CAR T or CAR NK - cell therapies in solid tumors."

Preclinical • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Eterna Therapeutics Completes Strategic Financial Restructuring with the Aim to Accelerate its Developmental Activities and Long-Term Success (GlobeNewswire) - "Eterna Therapeutics Inc...announced the successful completion of a comprehensive financial restructuring of the Company with the aim to accelerate its developmental activities and long-term success....Eterna continues to advance its lead therapeutic candidate ERNA-101....With these ongoing initiatives and a stronger financial position, Eterna believes it’s well-positioned for IND-enabling studies and targets IND submissions by 2026."

Commercial • IND • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer