REG - Syncona Limited - Autolus presents FELIX data at ASCO

SynconaAnnouncement

02/06/2023 12:15

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RNS Number : 5185B  Syncona Limited  02 June 2023

Syncona Limited

 

Autolus presents FELIX data at ASCO

 

 

2 June 2023

 

Syncona Ltd, a leading healthcare company focused on creating, building and
scaling global leaders in life science, notes that its portfolio
company, Autolus Therapeutics Plc (Nasdaq: AUTL) ("Autolus"), has announced
additional data from the pivotal Phase II FELIX study of obe-cel in adult r/r
B-cell Acute Lymphoblastic Leukemia (B-ALL) at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting. A copy of the announcement is set out
below, with key highlights as follows:

 

·      Obe-cel has demonstrated a response (CR/CRi) 1  of 76% amongst
patients dosed in the FELIX study; primary endpoint has already been met based
on previously communicated interim analysis

·      Encouraging safety profile with potential best-in-class
tolerability; only 3% of patients experienced Grade 3 or higher cytokine
release syndrome (CRS), and 7% of patients experienced Grade 3 or higher
immune effector cell-associated neurotoxicity syndrome (ICANS) 2 

·      Robust and reliable manufacturing and logistics, with 84% of the
112 patients enrolled in the FELIX trial being dosed with obe-cel

 

Management will host a conference call and webcast today at 4.00pm ET/9.00pm
BST to summarize the ASCO data. To listen to the webcast please go to the
events  (https://www.autolus.com/investor-relations/events/) section of
Autolus' website. Conference call participants should pre-register using this
link (https://register.vevent.com/register/BI358fc5b7456d41eead880006aa68db3f)
to receive the dial-in numbers and a personal PIN.

 

Martin Murphy, Chair of Syncona Investment Management Limited,
said: "Today's announcement further highlights the potential of obe-cel to
deliver meaningful impact for patients suffering from adult B-ALL. It is
encouraging to see response rates rise as increasing numbers of patients have
become evaluable for efficacy, with this set of data also further underlining
the potentially differentiated safety profile of the drug compared to other
alternative CAR-T therapies. We look forward to further updates from the FELIX
study throughout the year, which will provide further insight on its potential
durability, and to Autolus' planned filing of its BLA with the FDA later in
the year as it prepares for the commercial launch of obe-cel."

 

 ENDS 

 

Copies of this press release and other corporate information can be found on
the company website at: www.synconaltd.com (http://www.synconaltd.com/)

 

Forward-looking statements - this announcement contains certain
forward-looking statements with respect to the portfolio of investments of
Syncona Limited. These statements and forecasts involve risk and uncertainty
because they relate to events and depend upon circumstances that may or may
not occur in the future. There are a number of factors that could cause actual
results or developments to differ materially from those expressed or implied
by these forward-looking statements. In particular, many companies in the
Syncona Limited portfolio are conducting scientific research and clinical
trials where the outcome is inherently uncertain and there is significant risk
of negative results or adverse events arising. In addition, many companies in
the Syncona Limited portfolio have yet to commercialise a product and their
ability to do so may be affected by operational, commercial and other risk

 

Enquiries

 

Syncona Ltd

 

Annabel Clark / Fergus Witt

Tel: +44 (0) 20 3981 7940

 

FTI Consulting

 

Ben Atwell / Natalie Garland-Collins / Julia Bradshaw / 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 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 Presents Positive Results from Pivotal Phase 2 FELIX
study in adult r/r B-ALL at ASCO

 

-     76% of patients treated with obe-cel in the FELIX study achieved a
response (CR/CRi), primary endpoint has been met based on previously
communicated interim analysis

-     Potential best in class tolerability, with very low levels of
high-grade CRS and ICANS

-     Robust and reliable manufacturing and logistics, with 84% of
enrolled patients receiving obe-cel

-     Analyst call to be held today, June 2, 2023 at 4.00 pm ET/9.00 pm
BST

 

 

LONDON, June 2, 2023 -- Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announces the presentation of top-line data from the
Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-cell Acute Lymphoblastic
Leukemia (B-ALL) at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting.

 

In the pivotal morphological cohort of the FELIX trial, 112 patients with r/r
adult ALL were enrolled and 94 (84%) patients were dosed with obe-cel. Of the
dosed patients, 76% patients achieved a complete response (CR) or CR with
incomplete haematological recovery (CRi), and 97% of the responders with
evaluable samples were in deep remission with no detectable minimal residual
disease (MRD). Furthermore, at a 9.5-month median follow up, 61% of responders
remained in ongoing remission without new anti-cancer therapies. CAR T
cellular kinetics demonstrate excellent CAR T engraftment and persistence and
are consistent with the prior ALLCAR19 study.

 

Safety analysis demonstrated a potentially best-in-class tolerability profile
with Grade ≥3 cytokine release syndrome (CRS) and immune effector
cell-associated neurotoxicity syndrome (ICANS) in 3% (3/94) and 7% (7/94) of
patients, respectively. Most of the toxicity was seen in patients with high
disease burden. Notably, 6 of 7 Grade ≥3 ICANS were observed among patients
with very high tumor burden of more than 75% bone marrow blasts at
lymphodepletion. Overall, grade ≥3 adverse events occurred in 79% of
patients, with neutropenia (36.2%), and thrombocytopenia (25.5%) most commonly
reported.

 

Manufacturing was reliable and consistent, with product released for 94% of
leukapheresed patients and median turnaround times of 21 days from vein to
release.

 

"We are very encouraged by the outcome of the FELIX study. Obe-cel shows low
immunotoxicity, high complete remission rates and excellent CAR T expansion
and persistence in adult B-ALL. These data are consistent with the prior
ALLCAR19 study and suggest that obe-cel has the potential for long-term
clinical benefit in adult B-ALL patients without additional therapies," said
Dr. Claire Roddie, Associate Professor at UCL, Honorary Consultant
Haematologist at UCLH.

 

"We are pleased that our pivotal FELIX study confirms the attractive product
profile for obe-cel, combining a high level of clinical activity with an
excellent safety profile which we know is critical for this highly pre-treated
and frail patient population. Conducting this study through the pandemic was a
pressure test for obe-cel's product profile and our ability to deliver obe-cel
reliably under difficult circumstances. We would like to thank patients, their
care givers, nurses and treating physicians for their participation in the
FELIX study." said Dr. Christian Itin, Chief Executive Officer of Autolus.

 

"With the Nucleus, our commercial manufacturing facility, well advanced in
validation we look forward to submitting a BLA towards the end of this year
and working with the FDA to get obe-cel to patients as soon as possible."

 

ASCO Oral Presentation, abstract #7000:

 

Title:    Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1),
a fast-off rate CD19 CAR in relapsed/refractory adult B-Cell acute
lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

 

Session Title:  Hematologic Malignancies - Leukemia, Myelodysplastic Syndromes, and Allotransplant

Session date and time: Friday, June 2, 2023, 2.00 pm -2.12 pm ET, 7.00 pm -
7.12 pm BST

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

 

 

Additional data from the FELIX study will be presented as an Oral Presentation
at the upcoming European Hematology Association (EHA) meeting:

 

Title:    Safety and efficacy of Obecabtagene autoleucel (obe-cel, AUTO1),
a fast-off rate CD19 CAR in relapsed/refractory adult B-Cell acute
lymphoblastic leukemia (r/r B-ALL): Topline results of the pivotal FELIX study

 

Presentation ID: S262

Session date and time: Saturday, June 10, 2023, 11.00 am - 11.15 am ET, 4.00
pm - 4.15 pm BST

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

 

Conference Call

Autolus will host a conference call and webcast today for analysts at 4.00 pm
ET/9.00 pm BST to summarize the ASCO data. Conference call participants should
pre-register using this link
(https://register.vevent.com/register/BI358fc5b7456d41eead880006aa68db3f) to
receive the dial-in numbers and a personal PIN, which are required to access
the conference call.

 

A simultaneous audio webcast and replay will be accessible on the events
section (https://www.autolus.com/investor-relations/news-and-events/events) of
Autolus' website.

 

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 (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. 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 Autolus' academic partner, UCL,
obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.
Autolus has progressed obe-cel to the FELIX trial, a pivotal trial for adult
ALL.

 

About obe-cel FELIX clinical trial

Autolus' Phase 1b/2 clinical trial of obe-cel enrolled adult patients with
relapsed / refractory B-precursor ALL. The trial had a Phase 1b 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 

 

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 expected benefits
and continued development of Autolus' obe-cel program; the planned submission
of a Biologics License Application for obe-cel by the end of 2023; and the
Company's manufacturing capabilities, including the completion and validation
of the Nucleus facility. 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 and
Cardinal Health are unable agree on a definitive agreement, or that the
arrangement described in such an agreement does not produce the desired
results; Autolus' preclinical or clinical programs do not advance or result in
approved products on a timely or cost effective basis or at all; 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. 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)

 

Alexandra Deschner

+32-490-58-35-23

a.deschner@autolus.com (mailto:a.deschner@autolus.com)

 

 

 

 

# # #

 

 1  Calculated from the proportion of patients achieving Complete Remission
(CR) and CR with incomplete haematological recovery (CRi)

 2  Severe cases of CRS and ICANS (≥ grade 3) are likely to require
admission to the intensive care unit

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