REG - Syncona Limited - Autolus to present clinical data updates at ASH

SynconaAnnouncement

02/11/2023 13:15

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RNS Number : 2278S  Syncona Limited  02 November 2023

 

 

 

Syncona Limited

 

Autolus to present clinical data updates at ASH

 

2 November 2023

 

Syncona Ltd, a leading healthcare company focused on creating, building and
scaling a portfolio of global leaders in life science, notes that its
portfolio company, Autolus Therapeutics Plc (Nasdaq: AUTL) ("Autolus"), has
announced that it will present clinical data updates, including from its
pivotal Phase II FELIX study of obe-cel in adult r/r B-cell acute
lymphoblastic leukaemia (B-ALL), at the American Society of Hematology (ASH)
Annual Meeting 2023.

 

Highlights from the presentations include:

 

·     In the pivotal trial of obe-cel in Adult ALL, the observed
response rate 1  of 77 per cent amongst the 126 patients dosed in the study at
11 months follow up is consistent compared to previously presented data

·     The data also continues to show an encouraging safety profile with
potentially best-in-class tolerability with only 2 per cent of patients
experiencing Grade 3 or higher CRS 2 , and 7 per cent experiencing Grade 3 or
higher ICANS 3 

·    Pooled analysis from the Phase Ib portion and the extension studies
further underlines the durability profile of obe-cel, with more than a third
of patients remaining in remission without transplant at a median follow up of
more than three years

·   Oral presentation on the initial data from the Phase I trial of AUTO8
in multiple myeloma shows initial clinical responses observed in six patients
at a median follow up of 4.5 months; the data also supports the initial safety
profile of the drug

 

Further data will be presented within the presentations at ASH, including
longer follow-up data from the FELIX study.

 

Martin Murphy, Chair of Syncona Investment Management Limited, said: "We are
pleased by the further efficacy and safety data observed in the FELIX trial of
obe-cel in adult B-ALL, with the durability of the therapy looking
encouraging. We believe that obe-cel has the potential to be best-in-class and
deliver meaningful impact for patients suffering from adult B-ALL. We look
forward to Autolus BLA submission for obe-cel with the FDA later this year,
and to its planned commercial launch in 2024, pending the necessary regulatory
approvals."

 

The announcement can be accessed on Autolus' investor website
at https://www.autolus.com/investor-relations/news/
(https://www.autolus.com/investor-relations/news/)  and the full text of the
announcement from Autolus, including the details of the two oral and two
poster presentations, is contained below.

 

 ENDS 

 

Enquiries

 

Syncona Ltd

 

Annabel Clark / Fergus Witt

Tel: +44 (0) 20 3981 7940

 

FTI Consulting

 

Ben Atwell / Natalie Garland-Collins / Tim Stamper

Tel: +44 (0) 20 3727 1000

 

 

About Syncona

 

Syncona's purpose is to invest to extend and enhance human life. We do this by
creating and building companies to deliver transformational treatments to
patients in areas of high unmet need.

 

Our strategy is to create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 globally leading healthcare
businesses, across development stage and therapeutic areas, 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 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 poor
treatment options, build sustainable life science companies and deliver strong
risk-adjusted returns to shareholders.

 

 

 

Autolus Therapeutics to Present Clinical Data Updates at the American Society
of Hematology (ASH) Annual Meeting 2023 in Two Oral Presentations and Two
Poster Presentations

 

-     obe-cel: oral presentation - pooled analysis of the ongoing FELIX
Phase Ib/II study

-     AUTO8: oral presentation of MCARTY Phase I Study

-     obe-cel: poster presentation - pooled analysis from ALLCAR19 and
FELIX Phase Ib studies and ALLCAR19 extension

-     obe-cel: poster presentation - CMC demonstrating the robustness of
obe-cel manufacturing

 

LONDON, November 2, 2023 -- Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announces the online publication of four abstracts
submitted to the American Society of Hematology (ASH) Annual Meeting, to be
held December 9 to 12, 2023.

 

"We look forward to presenting data from a number of our clinical trials at
ASH this year, with obe-cel continuing to show a potentially best-in-class
profile across several indications," said Dr. Christian Itin, Chief Executive
Officer of Autolus. "Importantly, ahead of our expected BLA filing later this
year, we will be presenting safety, efficacy and longer follow up data of
obe-cel in relapsed/refractory B-ALL from the FELIX phase Ib and the pivotal
phase II study, a pooled analysis from the ALLCAR19 and FELIX Phase Ib studies
and the ALLCAR19 extension study, as well as data demonstrating the robustness
of obe-cel's manufacturing process. Additionally, we will be presenting the
first AUTO8 clinical data from the MCARTY Phase I study in multiple myeloma."

 

Oral Presentations:

 

1.   Title: Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory
Adult B-cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the
Ongoing FELIX Phase Ib/II Study

Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational
Therapies: Expanding Disease Targets for CAR-T Cell Therapies

Session date and time: Saturday, December 9, 2023, 3:15 PM PT

Session room: San Diego Convention Center, Room 6B

Publication Number:  222

Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor
Haematology and Honorary Consultant Haematologist, Cancer Institute,
University College London (UCL)

 

Summary:

Obe-cel is an autologous chimeric antigen receptor (CAR) T cell product with a
novel CD19 binding domain conferring a fast antigen off-rate designed for an
improved benefit risk ratio.

In this session, pooled analysis of data from all patients treated to date in
the FELIX study will be presented, with an extended follow up. Data continued
to demonstrate high rates of CR/CRi and a favorable safety profile.
Additionally, subgroup analysis data suggests better outcomes in patients with
low leukemia burden at screening/lymphodepletion, with higher rates of deep
MRD negative complete remission and no Gr ≥3 CRS and one Gr ≥3 ICANS.

 

2.   Title: Development of a Phase I Study Evaluating the Activity of
Modular CAR T for Multiple Myeloma (MCARTY) Targeting BCMA and CD19 for
Improved Persistence

Session Title: 703. Cellular Immunotherapies: Basic and Translational:
Cellular Immunotherapy: Preclinical and Translational Insights

Date and time: Saturday, December 9, 2023, 4:15 PM PT

Session room: San Diego Convention Center, Room 6A

Publication Number:  350

Presenting Author: Dr. Lydia Lee, Consultant Haematologist & Senior
Clinical Research Fellow, University College

London, Research Department of Haematology (UCLH)

 

Summary:

AUTO8 is a dual targeting autologous CAR T therapy targeting BCMA and CD19
using two independently expressed CARs for multiple myeloma. In the MCARTY
study, we demonstrate dual CD19/BCMA targeting, alongside feasibility of
clinical grade manufacture by double-transduction. Clinical responses were
seen in 6 of 6 evaluable patients.

 

Poster Presentations:

 

1.   Title: Long-Term Efficacy and Safety of Obecabtagene Autoleucel
(obe-cel) in Adult Patients (pts) with Relapsed/Refractory B-cell Acute
Lymphoblastic Leukemia ([R/R B-ALL]; Pooled Analysis from ALLCAR19 and FELIX
Phase Ib Studies) or Other B-cell Malignancies (ALLCAR19 Extension Study)

Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational
Therapies: Poster I

Session date and time: Saturday, December 9, 2023, 5:30 PM - 7:30 PM PT

Session room: San Diego Convention Center, Halls G-H

Publication Number:  2114

Presenting Author: Dr. Claire Roddie, MD, PhD, FRCPath, Associate Professor
Haematology and Honorary Consultant Haematologist, Cancer Institute,
University College London (UCL)

 

Summary:

The clinical activity of obe-cel has been explored in adults with R/R B-ALL in
a Phase I study (ALLCAR19), and a Phase Ib/II study (FELIX). Additionally,
obe-cel has been tested in patients with R/R B-cell chronic lymphocytic
leukemia (B-CLL) and R/R B-cell non-Hodgkin lymphoma (B-NHL).

Data from the pooled analysis of r/r ALL patients treated with obe-cel in the
ALLCAR19 and FELIX Ib studies demonstrate that after a median follow up of
>3 years approximately 30% of patients remain in remission without
subsequent transplant. In the CLL and NHL cohorts of the ALLCAR19 study and
with >2 years follow up, the studies show durable responses and a low
incidence of serious infections. In summary, obe-cel shows durable remissions
in a range of B-cell malignancies with an excellent and consistent safety
profile.

 

2.   Title: Delivery of Obecabtagene Autoleucel (obe-cel, AUTO1) for the
FELIX Pivotal Study Demonstrating Robust Cell Processing, Robust Release
Testing, and Reliable Logistics, Together with Readiness for Sustainable
Patient (pt) Care

Session Title: 711. Cell Collection and Processing: Poster III

Session date and time: Monday, December 11, 2023, 6:00 PM - 8:00 PM PT

Session room: San Diego Convention Center, Halls G-H

Publication Number:  4892

Presenting Author: Michael Merges VP, Process Development, Autolus

 

Summary:

The FELIX study successfully demonstrated the robust operability of obe-cel
manufacturing, QC and logistics processes, meeting target V2C (time from
leukapheresis to quality release) and V2D (time from leukapheresis to delivery
of product to the hospital). All apheresis starting material was successfully
processed despite the multitude of constraints posed by the COVID-19 pandemic.
Further optimization and improvements made during the study increased
reliability, consistency and precision of the manufacturing process, and
supported the development of a new obe-cel manufacturing facility with greater
production capacity that aims to achieve a ≥95% manufacturing success rate
with ≤15-day V2C times.

 

# # #

 

About Autolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing
next-generation, programmed T cell therapies for the treatment of cancer and
autoimmune disease. 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 target 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, solid tumors and autoimmune
diseases. For more information, please visit www.autolus.com.

 

About obe-cel (AUTO1)

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. Obe-cel is designed with a fast target binding off-rate to
minimize excessive activation of the programmed T cells. Clinical trials of
obe-cel have demonstrated that this "fast off-rate" profile reduces toxicity
and  T cell exhaustion, resulting in improved persistence and leading to high
levels of durable remissions in r/r Adult ALL patients. The results of the
FELIX trial, a pivotal trial for adult ALL, are being prepared for regulatory
submissions with the FDA and EMA. In collaboration with Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase I clinical
trials for B-NHL.

 

About obe-cel FELIX clinical trial

Autolus' Phase Ib/2 clinical trial of obe-cel enrolled adult patients with
relapsed / refractory B-precursor ALL. The trial had a Phase Ib component
prior to proceeding to the single arm, Phase 2 clinical trial. The primary
endpoint is overall response rate, and the secondary endpoints include
duration of response, MRD negative CR rate and safety. The trial enrolled over
100 patients across 30 of the leading academic and non-academic centers in the
United States, United Kingdom and Europe.  NCT04404660 

 

About AUTO8

AUTO8 is our next-generation product candidate for multiple myeloma which
comprises two independent CARs for the multiple myeloma targets, BCMA and
CD19. We have developed an optimized BCMA CAR which is designed for improved
killing of target cell that express BCMA at low levels. This has been combined
with fast off rate CD19 CAR from obe-cel. We believe that the design of AUTO8
has the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in development.

 

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 development of
Autolus' product candidates, the status of clinical trials (including, without
limitation, expectations regarding the data that is being presented, the
expected timing of data releases and development, as well as completion of
clinical trials) and development timelines for the Company's product
candidates. 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
COVID-19 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 7, 2023,
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

+44 (0) 7818 430877

j.wilson@autolus.com (mailto:j.wilson@autolus.com)

 

Susan A. Noonan

S.A. Noonan Communications

+1-917-513-5303

susan@sanoonan.com (mailto:susan@sanoonan.com)

 

Lauren Williams

Investase

+44 23 9438 7760

lauren@investase.com

 

 

 

# # #

 

 1  Complete response / CR with incomplete haematological recovery

 2  Cytokine release syndrome (CRS) is a systemic inflammatory response caused
by cytokines released by infused CAR-T cells and is the most common type of
toxicity caused by CAR-T cells

 3  Immune effector cell-associated neurotoxicity syndrome (ICANS) is a common
and usually reversible toxicity of CAR-T cell therapy, often occurring after
CRS

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