Autolus to present additional data in AUTO1

RNS Number : 3599Y

Syncona Limited

12 May 2021

 

Syncona Limited

Autolus to present additional data in AUTO1 in IBCL

12 May 2021

Syncona Ltd, a leading healthcare company focused on founding, building and funding a portfolio of global leaders in life science, notes that its portfolio company, Autolus Therapeutics Plc (NASDAQ: AUTL) (Autolus), has today announced new data highlighting progress in the company's AUTO1 CAR T cell therapy, being investigated in the ongoing Phase 1 study in relapsed / refractory indolent B cell lymphomas (IBCL). An abstract presentation will be presented at the European Hematology Association (EHA) All-Virtual Congress, held between June 9-17, 2021.

Autolus noted that AUTO1 demonstrated a tolerable safety profile in adult patients with IBCL despite high disease burden. Early data in 10 patients showed 100% complete remission rates and excellent CAR engraftment/expansion.

The announcement can be accessed on the Autolus website at: https://www.autolus.com/investor-relations/ and the full text of the announcement is contained below.

All e-poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 11 at 9.00 AM CEST, where participants can also now register their attendance.

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About Syncona

Syncona's purpose is to invest to extend and enhance human life. We do this by founding, building and funding a portfolio of global leaders in life science, to deliver transformational treatments to patients in areas of high unmet need.

Our strategy is to found, build and fund companies around exceptional science to create a dynamic portfolio of 15-20 globally leading healthcare businesses for the benefit of all our stakeholders. We focus on developing treatments for patients by working in close partnership with world-class academic founders and management teams. Our strategic balance sheet underpins our strategy enabling us to take a long-term view as we look to improve the lives of patients with no or few treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders.

Autolus Therapeutics to Present New Data on AUTO1 in r/r Indolent B Cell Lymphomas at the European Hematology Association Virtual Congress

AUTO1 achieves 100% complete remission rate in cohort of r/r Indolent Non- Hodgkin Lymphoma patients

No high-grade cytokine release syndrome or neurotoxicity observed

LONDON , May 12, 2021 --  Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced an abstract presentation related to AUTO1 in relapsed / refractory (r/r) indolent B cell lymphomas (IBCL) at the European Hematology Association ( EHA ) Virtual Congress to be held June 9-17, 2021.

Title: Early safety and efficacy findings of AUTO1 (CAT19), a fast-off rate CD19 CAR, in Relapsed/Refractory Indolent B Cell Lymphomas

Presenter: Clare Roddie, MD, PhD, FRCPath, Consultant Haematologist and Honorary Senior Lecturer, Cancer Institute, University College London (UCL)

Date and Time:   All e-poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 11 at 9.00 AM CEST.

As of the data cut-off date of February 18, 2021, 10 r/r IBCL patients had received AUTO1 and nine patients were evaluable. AUTO1 demonstrated a tolerable safety profile in adult patients with r/r low grade B-cell lymphoma despite high disease burden. Early data shows 100% complete remission rates and excellent CAR engraftment and expansion. Grade 1 CRS was reported in 4 patients and Grade 2 CRS in 1 patient. No Immune effector cell-associated neurotoxicity syndrome (ICANS) was observed on study. At a median of 3.1 months (range 1-5.6m), 8/9 patients are in ongoing remission. One patient died in complete remission at month 5.6 of COVID-19.

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 AUTO1 

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.

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 AUTO1, 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:

Julia Wilson

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Susan A. Noonan

S.A. Noonan Communications

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[e-mail]

 

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