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Editas Medicine Announces New EDIT-301 Safety and Efficacy Data in 17 Patients, Presented Today at the American Society of Hematology (ASH) Annual Meeting and in a Company-sponsored Webinar
All RUBY patients with ≥5 months follow-up have achieved a normal hemoglobin level and a fetal hemoglobin level of >40% All patients treated in the RUBY trial
About this update from Editas Medicine, Inc.
[{"type":"text","content":"All RUBY patients with ≥5 months follow-up have achieved a normal hemoglobin level and a fetal hemoglobin level of >40% All patients treated in the RUBY trial are free of vaso-occlusive events post-EDIT-301 infusion EDIT-301 was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant EDIT-301 is now known as renizgamglogene autogedtemcel (reni-cel) Company-sponsored webinar on the RUBY and EdiTHAL data today at 1:00 p.m. ET; ASH poster presentation today at 9:00 p.m. ET/6:00 p.m. PT CAMBRIDGE, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today announced new safety and efficacy data in 17 patients treated with EDIT-301, now known as renizgamglogene autogedtemcel (reni-cel), in the RUBY trial for severe sickle cell disease (SCD) (n=11) and in the EdiTHAL trial for transfusion-dependent beta thalassemia (TDT) (n=6). The total dataset of 17 treated patients includes 12 additional patients since the data presentation at the European Hematology Association (EHA) Annual Congress and in a Company-sponsored webinar this past June. Reni-cel is being investigated in the RUBY and EdiTHAL clinical trials as a potential one-time, durable gene editing medicine for people living with severe SCD and TDT. Editas Medicine will present the RUBY and EdiTHAL trial data today at 1 p.m. ET in a Company-sponsored webinar. The data will also be presented in a poster presentation at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA, at 6:00 p.m. PT (9:00 p.m. ET). In both the RUBY and EdiTHAL trials to date, reni-cel was well-tolerated and continues to demonstrate a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients in the two trials (n=17). Since treatment with reni-cel, all RUBY patients are free of vaso-occlusive events (VOEs) (n=11). All RUBY patients with ≥5 months follow-up have maintained a normal hemoglobin level and a fetal hemoglobin level of >40%. All EdiTHAL patients had early and robust increase of total hemoglobin, above the transfusion independence threshold of 9 g/dl (n=6). “These new and promising data with a larger patient cohort support our belief that reni...