Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site

Core Insights - Autolus Therapeutics plc has received Manufacturer's Importation Authorisation (MIA) and a GMP certificate for its Nucleus manufacturing facility, enabling global commercial and clinical product supply starting March 18, 2024 [1][2] - The MHRA inspection found no major or critical observations, indicating a successful certification process for both clinical and commercial manufacturing [1][2] Company Overview - Autolus is a clinical-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [3] - The company has a pipeline targeting hematological malignancies, solid tumors, and autoimmune diseases [3] Product Development - Obe-cel, an investigational CD19 CAR T cell therapy, has received multiple designations including Orphan Drug Designation from the FDA and EMA, and RMAT designation from the FDA for adult relapsed/refractory B-ALL [2][4] - Clinical trials for obe-cel have shown a "fast off-rate" profile that reduces toxicity and T cell exhaustion, leading to improved persistence and durable remissions in patients [4] Clinical Trials - The Phase Ib/II clinical trial of obe-cel enrolled over 100 patients across 30 leading centers in the US, UK, and Europe, focusing on overall response rate and safety [5]