Autolus Therapeutics provides an update on its manufacturing facility in Stevenage, UK

Rhea-AI Summary

Autolus Therapeutics has received planning approval to construct a new manufacturing facility in Stevenage, UK, aimed at enhancing global commercial launch capacity for obe-cel (AUTO1). The 70,000 square foot facility will allow for GMP production of approximately 2,000 batches annually, with potential for expansion. The company anticipates pivotal data from the FELIX study in 2022 for treating adult patients with acute lymphoblastic leukemia (ALL). This new facility positions Autolus to secure its place in Europe's growing biotechnology sector.

Positive

• Planning approval received for a new manufacturing facility in Stevenage.
• Facility will provide GMP capacity for approximately 2,000 batches annually.
• Positioning Autolus to secure global commercial launch capacity for obe-cel.

Negative

• None.

- Allowing global commercial launch capacity for obe-cel (AUTO1)

LONDON, Sept. 16, 2021 (GLOBE NEWSWIRE) -- 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.

About Obe-cel 
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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the future clinical development, efficacy, safety and therapeutic potential of obe-cel, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical activity and milestones; expectations regarding the initiation, design and reporting of data from clinical trials. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus’ business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 4, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Lucinda Crabtree, PhD
Vice President, Business Strategy and Planning
+44 (0) 7587 372 619
l.crabtree@autolus.com

Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com

Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com 

FAQ

What is the significance of the new manufacturing facility for Autolus Therapeutics (AUTL)?

The new manufacturing facility will enhance Autolus's ability to produce obe-cel at scale, supporting its global commercial launch.

When is the data from the FELIX study expected for Autolus's obe-cel (AUTO1)?

Data from the pivotal FELIX study is expected in 2022.

What is obe-cel designed to treat?

Obe-cel is designed to treat adult patients with acute lymphoblastic leukemia (ALL).

Where is the new Autolus manufacturing facility located?

The new manufacturing facility is located in Stevenage, UK.

How many batches can the new facility produce initially?

The new facility will initially allow for the production of approximately 2,000 batches annually.