Allowing global commercial launch capacity for obe-cel (AUTO1)
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that planning approval has been granted to build the Company’s new manufacturing facility in Stevenage, UK. The 70,000 square foot facility is being built by Merit Holdings Limited as general contractor for the Reef Group, who will lease the facility to Autolus. Global commercial launch capacity for obecabtagene autoleucel (obe-cel) will initially be provided by the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult (CGTC) facility, and will then move to the new Autolus facility which will allow for GMP capacity for approximately 2,000 batches a year initially, with scope to expand.
“Stevenage is rapidly becoming one of Europe’s largest clusters for biotechnology and the establishment of our own manufacturing facility will secure global commercial launch capacity for obe-cel,” said Dr. Christian Itin, chief executive officer of Autolus. “We are excited by the progress we are making with obe-cel for the treatment of adult patients with acute lymphoblastic leukemia (ALL) and expect data from the pivotal FELIX study in 2022.”
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.
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. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, Obe-cel 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, Obe-cel is currently being evaluated in a Phase 1 clinical trial in adult ALL and B-NHL. The company has also progressed Obe-cel to the FELIX study, a potential pivotal study.
About Obe-cel FELIX study
The FELIX Phase 1b/2 clinical trial 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.