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ERNA 事件
Ernexa Therapeutics Reports Encouraging Safety Results for ERNA-101
Ernexa Therapeutics announced "highly encouraging" results from three core Investigational New Drug-enabling safety studies of ERNA-101, its lead synthetic, allogeneic induced mesenchymal stromal cell therapy engineered to express an IL-7/IL-15 fusion cytokine. Across repeat-dose GLP toxicology, tumorigenicity and biodistribution studies, ERNA-101 demonstrated a favorable nonclinical safety profile, with results addressing three critical questions: Repeat-dose safety: No ERNA-101-related adverse findings were observed at any dose level tested in a 50-day GLP toxicology study in tumor-bearing mice with an intact immune system; Tumorigenicity: No teratoma formation was observed in ERNA-101-treated animals through the six-month tumorigenicity in-life phase, addressing an important safety consideration for an iPSC-derived therapy; Biodistribution: No significant ERNA-101 signal was detected in tumor-free animals or non-tumor tissues, supporting ERNA-101's design to home to tumors without taking up residence elsewhere in the body.
Ernexa Therapeutics Selected for Emerging Track at 2026 Cell & Gene Meeting
Ernexa Therapeutics announced that the Company has been selected for the Emerging Track at the 2026 Cell & Gene Meeting on the Mesa, taking place October 5-7, 2026, in Mesa, Arizona. As part of this recognition, Chief Executive Officer Sanjeev Luther will deliver an Innovation Spotlight presentation. During the presentation, Luther will showcase Ernexa's differentiated off-the-shelf induced mesenchymal stem cell, or iMSC, platform and the Company's progress toward becoming a clinical-stage oncology company. Luther will also highlight the differentiated characteristics of Ernexa's synthetic iMSC platform, as well as recently announced preclinical findings supporting the therapeutic potential of ERNA-101, including: In a larger, statistically robust study conducted by an independent contract research organization, ERNA-101 in combination with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in two-thirds of treated animals; ERNA-101 in combination with PD-1 blockade achieved complete tumor clearance and 100% survival through the end of the study follow-up period, demonstrating the potential of ERNA-101 to enhance the activity of checkpoint inhibition in an immunologically cold tumor model; Ernexa remains on track for a planned Investigational New Drug application submission for ERNA-101 in 2026.
Ernexa Therapeutics Announces Preliminary Results for ERNA-201
Ernexa Therapeutics announced preliminary preclinical results for ERNA-201, its synthetic, allogeneic induced mesenchymal stem cell therapy engineered to express anti-inflammatory factors, while outlining a sharpened oncology strategy designed to accelerate the company's transition into the clinic and expand the long-term potential of its proprietary synthetic iMSC platform. In preliminary studies using the collagen-induced arthritis model, an industry-standard preclinical model for rheumatoid arthritis and inflammatory joint disease, several ERNA-201 lead candidates demonstrated reductions in disease severity relative to untreated controls, including improvements in clinical arthritis scores consistent with the therapy's intended anti-inflammatory mechanism of action. Ernexa believes these results represent an important scientific milestone: ERNA-201 demonstrated meaningful preclinical proof-of-concept in inflammatory disease, providing additional evidence that the company's engineered iMSC platform can be programmed to deliver therapeutically relevant factors across distinct disease settings. With this platform validation in hand, Ernexa is concentrating its near-term capital and operational resources on advancing ERNA-101 into a first-in-human clinical study in platinum-resistant ovarian cancer. Mice treated with several ERNA-201 lead candidates demonstrated reductions in disease severity relative to untreated controls, including improvements in clinical arthritis scores. Ernexa believes the findings are consistent with the candidate's intended anti-inflammatory mechanism and provide meaningful proof-of-concept support for the use of synthetic, cytokine-engineered iMSCs in inflammatory and autoimmune disease. 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. Following the ERNA-201 results, Ernexa has elected to pause additional preclinical development expenditures on ERNA-201 at this time and preserve the program while concentrating near-term resources on ERNA-101 and the expansion of its oncology pipeline.
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Ernexa Therapeutics Validates ERNA-101 Anti-Tumor Activity with PD-1 Inhibition
Ernexa Therapeutics announced new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition. The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101's mechanism of action and provide important third-party validation as the company advances toward its planned investigational new drug submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter. In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals. Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy. Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors. The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone. Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade. With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.
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