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

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