Autolus Therapeutics Announces Updated Manufacturing Facility Strategy Leveraging its UK Operations
- Autolus to expand on existing operations in the UK for commercial supply of AUTO1 resulting in a less capital-intensive commercial infrastructure strategy
- Mutual agreement to terminate lease for the manufacturing and office facility at 9950 Medical Center Drive, Rockville, MD, resulting in a cash payment to Autolus
LONDON, March 29, 2021 -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its updated manufacturing facilities strategy for commercial supply of AUTO1.
Autolus now plans to establish global commercial launch capacity in the UK, enabling the company to leverage the expertise and skill base of its U.K. employees. This will be provided by a combination of the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult (CGTC) facility and a new Autolus facility. This revised strategy aims to deliver a less capital-intensive commercial manufacturing infrastructure at a lower cost base.
In conjunction with this new facilities strategy, Autolus’ lease for the manufacturing and office facility at 9950 Medical Center Drive in Rockville, MD, has been mutually terminated, triggering a cash payment to Autolus and ending all of the company’s payment obligations under the lease.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. 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 cancer 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 and solid tumors. For more information please visit www.autolus.com.
AUTO1 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. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with our academic partner, UCL, AUTO1 is currently being evaluated in a Phase 1 clinical trial in adult ALL and B-NHL. The company has also progressed AUTO1 to the FELIX study, a potential pivotal study.
About AUTO1 FELIX study
The FELIX study is enrolling adult patients with relapsed / refractory ALL. The trial has a short Phase 1b component prior to proceeding to a single arm Phase 2 clinical trial. The primary endpoint is overall response rate, and the key secondary endpoints include duration of response, MRD negative CR rate and safety. The trial will enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe.
- Autolus Therapeutics plc
- Autolus Therapeutics plc