Bristol Myers Squibb to receive access to Autolus’ RQR8 safety switch for use in cell therapy programs
Autolus to receive an upfront payment, with potential for near term option exercise fees and development milestone payments plus royalties
LONDON, October 4, 2022 - Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it has entered into an agreement with Bristol Myers Squibb (NYSE: BMY). The agreement grants Bristol Myers Squibb access to incorporate Autolus’ proprietary RQR8 safety switch into an initial set of selected cell therapy programs on a target-by-target basis for the treatment of cancer, with an option for Bristol Myers Squibb to incorporate the RQR8 safety switch in additional cell therapy programs beyond the initial set of selected programs.
Managing toxicities is a critical step in the successful application of programed cell therapies. Safety switches are designed to allow the use of pharmacological agents to selectively eliminate a cell therapy in the event a patient experiences severe adverse side effects from the treatment. Autolus’ proprietary RQR8 switch works by administration with the widely available and approved pharmaceutical antibody, rituximab. Once administered, rituximab binds to the engineered CD20 epitopes on the surface of the cell therapy and triggers selective cell death1.
Safety switches form part of Autolus’ industry-leading suite of cell programing modules that are designed to provide precise targeting, controlled, enhanced and sustained CAR T activity in a hostile tumor microenvironment.
Under the terms of the agreement, Autolus will receive an upfront payment for access to the RQR8 safety switch for the initial set of cell therapy programs with the potential for near term option exercise fees and development milestone payments. In addition, Autolus would be entitled to receive royalties on net sales of all Bristol Myers Squibb cell therapy products that incorporate the RQR8 safety switch.
“Safety switches are critical to the future of our field of advanced cell therapies. They allow us to develop approaches that are designed to significantly improve patient outcomes, whilst at the same time incorporating the potential to reduce the risk of severe adverse side effects from the treatment” said Dr. Martin Pule, CSO of Autolus. “Next-generation, modular CAR T innovation is at the core of Autolus and RQR8 is incorporated in several of our product candidates. We look forward to partnering with Bristol Myers Squibb to bring the potential utility of our proprietary safety switch to their programs. I would like to take this opportunity to thank our excellent research team at Autolus for their continued hard work.”
- Philip B, Pule, M., et al. ‘A highly compact epitope-based marker/suicide gene for easier and safer T-cell therapy’. Blood 2014; 124(8):1277-1287
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, Autolus 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.
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 development and commercialization of licensed products, the achievement of milestones, including receipt of any milestone payments or royalties and the potential benefits of the licensed technology. 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 programs incorporating the licensed technology do not advance or result in approved products on a timely or cost-effective basis or at all, and the impact of the ongoing COVID-19 pandemic. 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 10, 2022, 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.
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Susan A. Noonan
S.A. Noonan Communications