LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus' Nucleus manufacturing facility in Stevenage has obtained a Manufacturer's Importation Authorisation (MIA) together with the accompanying GMP certificate. This authorisation enables Autolus to manufacture for global commercial and clinical product supply from the Nucleus effective as of March 18, 2024.

Following a full site inspection in February 2024, Autolus's Nucleus site has recently received the formal certification from the MHRA. The MHRA issued two new licenses to cover both clinical and commercial manufacture from the site and found no major or critical observations in their summary report.

"We are really proud of our brand-new facility for autologous cell therapies. Our manufacturing team did an outstanding job qualifying, validating and taking into operation the Nucleus in record time and establishing the foundation for high quality product supply," commented Dave Brochu, Chief Technology Officer of Autolus. "We look forward to continuing to work with the MHRA, EMA and FDA throughout the evaluation process of obe-cel for patients with ALL and thank the internal team at Autolus for their hard work."

Obe-cel has been granted Orphan Drug Designation by the FDA, Orphan Medical Product Designation by the EMA, Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and PRIority MEdicines (PRIME) designation by the EMA for adult r/r B-ALL.

About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.

About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. Clinical trials of obe-cel have demonstrated that this "fast off-rate" profile reduces toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in r/r Adult ALL patients. The results of the FELIX trial, a pivotal trial for adult ALL, have been submitted and accepted by the FDA with a PDUFA action date of November 16, 2024 and a regulatory submission with the EMA is being prepared. In collaboration with Autolus' academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.