REG - Syncona Limited - Autolus presents clinical data updates at ASH

SynconaAnnouncement

12/12/2022 15:15

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RNS Number : 4139J  Syncona Limited  12 December 2022

Syncona Limited

 

Autolus presents clinical data updates at ASH Congress

 

12 December 2022

 

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 presented new data
highlighting progress across its broader portfolio at the American Society of
Hematology (ASH) Congress, held between 10-13 December, 2022. A copy of the
announcement is set out below, with key highlights as follows:

 

·     Positive durability data presented from the ALLCAR19 trial of
obe-cel in relapsed refractory (r/r) adult acute lymphoblastic leukemia (ALL),
with 35% of patients remaining in complete remission (CR) three years after
treatment with obe-cel

·     Encouraging efficacy data in obe-cel in relapsed/refractory B cell
non-Hodgkin's lymphoma (B-NHL), and chronic lymphocytic leukaemia (CLL), with
a 92% ORR (overall response rate) amongst patients evaluable for efficacy

·     Strong activity levels observed in the AUTO1/22 programme in
paediatric acute lymphoblastic leukaemia (pALL), alongside a favourable
tolerability profile in a heavily pre-treated population

·     Clinically meaningful responses in AUTO4 in T cell Lymphoma (TCL),
with sustained complete metabolic response (CMR) in patients at 9 and 12
months

 

Management will host a conference call and webcast on 12 December 2022 at
10.30am ET/3.30pm GMT to discuss the ASH data. To listen to the webcast and
view the accompanying slide presentation, please go to the events
(https://www.autolus.com/investor-relations/events/) section of Autolus'
website.

 

Martin Murphy, Chief Executive Officer and Chair of Syncona Investment
Management Limited, said: "It is fantastic to see the long-term follow up data
in the ALLCAR19 academic study of obe-cel in r/r adult ALL demonstrating its
durability potential. This follows on from the recent announcement that the
company has met its primary endpoint at interim analysis in the pivotal Phase
II FELIX trial of obe-cel. We are also pleased to see the release of
additional data from Autolus' broader pipeline, which reflects the strength of
the company's technology and platform at what is a very exciting moment in the
company's development. Autolus has a strong balance sheet and positive data in
its lead programme to power the business forward over the next year."

 

 

 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 to Present Clinical Data Updates at the American Society
of Hematology (ASH) Annual Meeting 2022

 

-     Obe-cel: 35% of relapsed/refractory adult B-ALL patients in the
ALLCAR19 trial remain in complete remission at a median follow up of three
years without the need for additional anti-leukemia therapy

-     Obe-cel: continues to show high level of sustained clinical activity
in B-NHL patients

-     AUTO1/22: no antigen negative relapse seen in responding patients

-     AUTO4: first sustained metabolic CRs at 9 and 12 months of follow-up
in T cell Lymphoma patients

 

LONDON, December 12, 2022 -- Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announces the online publication of three posters with
updates from three Phase 1 clinical trials to be presented at the American
Society of Hematology (ASH) Annual Meeting, December 10-13, 2022.

"With three years of median follow-up in our Phase 1 ALLCAR19 study we see 35%
of adult relapsed/refractory B-ALL patients treated with obe-cel in sustained
complete remissions between 24 and 47 months without any need for additional
anti-leukemia therapy. Remarkably, these patients in long term remissions also
have long-term persisting CAR T cells, a unique feature of obe-cel," said Dr.
Christian Itin, Chief Executive Officer of Autolus. "With the initial data
from the pivotal Phase 2 FELIX trial tracking the outcome of our previous
ALLCAR19 trial, we are excited about the potential prospects of obe-cel in
adult ALL patients and look forward to presenting the full data of the FELIX
study in mid-2023. The potentially best-in-class profile of obe-cel is
supported by the data we have observed in NHL, with continued high levels of
clinical activity paired with an encouraging tolerability profile across
DLBCL, MCL, FL and CLL."

"It's great to be presenting clinical updates for AUTO1/22 in pediatric B-ALL
and AUTO4 in peripheral T Cell Lymphoma. AUTO1/22 shows encouraging response
rates in patients ineligible for commercial CAR T therapy, with 83% of
patients achieving MRD negative complete responses. Importantly, we have not
observed antigen negative relapse," said Dr. Martin Pule, Chief Scientific
Officer at Autolus. "In the AUTO4 study, some patients have experienced
durable metabolic CRs, including one patient up to the one-year mark. This is
a notable finding given the poor prognosis of relapsed/refractory T cell
lymphomas."

Conference Call

Management will host a conference call and webcast at 10:30 am ET/3:30 pm GMT
to summarize the ASH data. The webcast can be accessed at this link
(https://edge.media-server.com/mmc/p/ovr2mpp3) .

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.

Posters to be presented:

1.   Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off
Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia
(B-ALL) and Other B-Cell Malignancies

LINK (https://www.autolus.com/media/oiahk2lp/3318-allcar19-ash-poster.pdf) to
poster

Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational
Therapies: Poster II
Session date and time: Sunday, December 11, 2022, 6:00 PM - 8:00 PM

Session room: Ernest N. Morial Convention Center, Hall D

Publication Number: 3318

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

Summary: In the B-ALL cohort, 7 out of 20 (35%) patients were observed to be
in ongoing Complete Remission (CR) at median follow up of 36 months (IQR
24-47) post-AUTO1 without the need for additional anti-leukemia therapy.
Ongoing long-term remissions appear to be associated with CAR-T persistence,
which was also observed in these 7 patients at their last follow-up. One
patient with a subsequent stem cell transplant (SCT) also achieved long term
remission but lost CAR T persistence after SCT. In the B-cell non-Hodgkin
lymphoma/chronic lymphocytic leukemia (NHL/CLL) cohorts, AUTO1 continues to
display a favorable tolerability profile with no immune effector
cell-associated neurotoxicity syndrome (ICANS) or Grade ≥ 3 cytokine release
syndrome (CRS) across different indications. Of 25 patients with NHL/CLL
evaluable for efficacy, the best overall response rate (ORR) was 23/25 (92%).
AUTO1 was observed to be well-tolerated and active in diffuse large B-cell
lymphoma (DLBCL), with 7 of 8 patients in ongoing CR at last follow-up. In
CLL, 4 of 5 treated patients achieved undetectable minimal residual disease
(uMRD) in the bone marrow (BM), ongoing at last follow-up. While no relapses
were seen in DLBCL patients, late CD19+ relapses were seen in follicular
lymphoma (FL), and ongoing CAR-T persistence appears to be important.

 

2.   Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells
May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for
Relapsed/Refractory ALL (AUTO1/22)

LINK (https://www.autolus.com/media/ochhrsgv/4650-carpall-poster.pdf) to
poster

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

Session date and time: Monday, December 12, 2022, 6:00 PM - 8:00 PM

Session room: Ernest N. Morial Convention Center, Hall D

Publication Number: 4650

Presenting Author: Dr. Sara Ghorashian, MD, PhD, Hon clinical senior lecturer,
UCL Great Ormond Street Institute of Child Health

Summary: AUTO1/22 demonstrated a strong level of activity with 83% (10/12) MRD
negative complete remissions and a favorable tolerability profile in a very
challenging patient population (4 patients failed previous Kymriah treatment
with three having CD19-negative disease, 3 had non-central nervous system
(CNS) extra-medullary disease, which is associated with poor outcomes with CAR
T therapy). AUTO1/22 showed excellent expansion, with a median 7.5 months
duration of persistence of CD22 CAR. No antigen negative relapse was seen in
responding patients. At a median follow up of 8.7 months, five of 10
responding patients were in MRD negative complete response (4-12 months) with
two after further therapy for early loss of CAR T persistence.

3.   Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR T-Cell
Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

LINK (https://www.autolus.com/media/1zsbaddr/4634-auto4-poster.pdf) to poster

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

Session date and time: Monday, December 12, 2022, 6:00 PM - 8:00 PM

Session room: Ernest N. Morial Convention Center, Hall D

Publication Number: 4634

Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University
College London Hospitals (UCLH)

Summary: Having shown proof of concept at EHA in June 2022, AUTO4 treatment
for peripheral T-cell Lymphoma continues to be observed to be well tolerated
with no dose-limiting toxicities. Ongoing responses at 9- and 12-months
post-dosing at the highest dose tested (450x106) are encouraging, and suggests
a potential clinical benefit for patients. No CAR T cell expansion was
observed in peripheral blood, but CAR T cells were detected in an on-treatment
lymph node biopsy. Optimization of the AUTO4 manufacturing process has been
performed, resulting in a product candidate with a more naive and central
memory phenotype. The study is ongoing, with additional patients due to be
treated to define the recommended Phase 2 dose.

 

# # #

 

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 (http://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 potential pivotal trial
for adult ALL.

About AUTO1/22

AUTO1/22 is a novel dual targeting CAR T cell-based therapy candidate based on
obe-cel. It is designed to combine the enhanced safety, robust expansion &
persistence seen with the fast off rate CD19 CAR from obe-cel with a high
sensitivity CD22 CAR to reduce antigen negative relapses. This product
candidate is currently in a Phase 1 clinical trial called CARPALL for patients
with r/r pediatric ALL. [NCT02443831
(https://clinicaltrials.gov/ct2/show/NCT02443831) ]

About AUTO4

AUTO4 is a programmed T cell product candidate in clinical development for T
cell lymphoma, a setting where there are currently no approved programmed T
cell therapies. AUTO4 is specifically designed to target TRBC1 derived
cancers, which account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in pre-clinical
development. AUTO4 has been tested in a Phase 1 clinical trial, LibRA1 for
patients with peripheral T cell Lymphoma.

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 Autolus' development of
the obe-cel program; the future clinical development, efficacy, safety and
therapeutic potential of its product candidates, 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; expectations
regarding regulatory approval process for any product candidates; the
collaboration between Autolus and Blackstone; the discovery, development and
potential commercialization of potential product candidates including obe-cel
using Autolus' technology and under the collaboration agreement; the
therapeutic potential for Autolus in next generation product developments of
obe-cel in B-cell malignancies; the potential and timing to receive milestone
payments and pay royalties under the strategic collaboration; and the
Company's anticipated cash runway. 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 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.

 

Contact:

 

Olivia Manser

+44 (0) 7780 471568

o.manser@autolus.com (mailto:o.manser@autolus.com)

 

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)

 

 

# # #

 

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