REG - Syncona Limited - Autolus Data Updates

SynconaAnnouncement

12/06/2025 13:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250612:nRSL6243Ma&default-theme=true

RNS Number : 6243M  Syncona Limited  12 June 2025

12 June 2025

 

Syncona Limited

 

Autolus to present data updates at EHA Congress

 

Syncona Ltd, ("Syncona" or the "Company") a leading life science investor
focused on creating, building and scaling global leaders in life
science, notes that its portfolio company Autolus Therapeutics
("Autolus") will present updated long term data from the FELIX study of
obecabtagene autoleucel (obe-cel) in adult patients with relapsed/refractory
(r/r) B-cell acute lymphoblastic leukaemia (B-ALL) in an oral presentation at
the European Hematology Association (EHA) Congress between 12-15 June 2025.
Autolus will also present an additional oral and poster presentation.

 

Key highlights from the presentations include:

 

·      Median duration of response in the FELIX study of obe-cel is now
42.6 months after an additional 11 months of follow up

·      38% of responders were in ongoing remission and did not receive
any subsequent therapy by month 33

·      More than half of patients were still in remission at 24 months

·      No new safety signals or Grade ≥3 secondary malignancies were
observed at the extended follow up

·      Results suggest a proportion of patients with r/r B-ALL may not
need further therapy following treatment with obe-cel

·      Deep and durable remissions were seen in both age groups (<55
years and ≥55 years) suggesting that obe-cel is effective and has a positive
benefit and risk profile regardless of patient age

·      Data suggests the ALL-Hematotox model appears to improve risk
stratification and may be a better predictor of response, survival and safety
outcomes in adult patients with r/r B-ALL treated with obe-cel, than
CAR-Hematotox

 

 

Autolus' announcement is copied below and can be accessed at the company's
website at

 https://www.autolus.com/investor-relations/news
(https://www.autolus.com/investor-relations/news)

 

 

 ENDS 

 

Enquiries

 

Syncona Ltd

 

Annabel Clark / Tim Stamper

Tel: +44 (0) 20 3981 7912

 

FTI Consulting

 

Ben Atwell / Natalie Garland-Collins

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, building and scaling companies to deliver transformational
treatments to patients in areas of high unmet need.

 

We aim to build and maintain a diversified portfolio of 20-25 globally leading
life science businesses, across development stage, modality and therapeutic
area, for the benefit of all our stakeholders. We focus on developing
treatments that deliver patient impact by working in close partnership with
world-class academic founders and experienced 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.

 

Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment
in Syncona Limited, including the information in our published documentation,
before investing.

 

Autolus Therapeutics Presents Long-Term Follow Up from the FELIX Study
Demonstrating Obe-Cel's Potential for Long-Term Remission in R/R B-ALL at the
2025 European Hematology Association (EHA) Congress

 

·      Median duration of response in FELIX study now 42.6 months after
an additional 11 months of follow up

·      More than half of patients still in remission at 24 months

·      38% of ongoing responders did not receive any subsequent therapy
by month 33

·      Results suggest a proportion of patients with r/r B-ALL may not
need further therapy following treatment with obe-cel

 

LONDON, June 12, 2025 -- Autolus Therapeutics plc (Nasdaq: AUTL), an early
commercial-stage biopharmaceutical company developing, manufacturing and
delivering next-generation programmed T cell therapies, today announces
updated long term data (up to approximately three years of follow up) from the
FELIX study of obecabtagene autoleucel (obe-cel) in adult patients with
relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL), to be
presented in an oral presentation at the European Hematology Association (EHA)
Congress between June 12-15, 2025, in Milan, Italy. Autolus will also present
an additional oral and poster presentation, the details of which are included
below.

 

"Obe-cel's durability of response without any subsequent therapy in two out of
every five responders is a key factor leading the transformation of therapy
for adult r/r B-ALL patients. At a median follow up of 33 months, we are
encouraged to see a continuation of the long-term plateau we observed at the
last data cut," said Dr. Christian Itin, Chief Executive Officer of Autolus.
"A well-tolerated, effective, durable treatment option for ALL patients who
often have a poor prognosis and have had multiple prior treatments is of
significant clinical benefit."

 

Oral S113:

Title: Can CAR T-cell therapy be a definitive treatment for adult r/r B-ALL
without transplant? Long-term findings and predictors of sustained remission
for obecabtagene autoleucel

Session Name: s447 Immunotherapy and CAR-T cells for ALL

Session room: Coral 6

Session Date and Time: Sunday, June 15; 11:00 - 12:15 CEST

Presenting Author: Jae H Park, MD

 

Summary: At the updated median follow up of 32.8 months, 38.4% of responders
were in ongoing remission without consolidative SCT or other therapies (versus
the previously reported 40% at a median follow up of 21.5 months). The
24-month probability of Event Free Survival was 43%, and for Overall Survival
was 46%, with an emerging long-term plateau observed. A substantial subset of
patients benefit from standalone treatment with obe-cel, achieving long-term
remission. No new safety signals or Grade ≥3 secondary malignancies were
observed at the extended follow-up. These results suggest that obe-cel may be
a definitive treatment for some patients with r/r B-ALL - specific analysis
will be needed to determine which patients may need additional treatments.

 

The multivariate analysis demonstrated that Philadelphia chromosome-positive
disease, earlier obe-cel use, and relapsed disease correlated with achieving
higher remission rates. Lower disease burden at lymphodepletion and ongoing
CAR T-cell persistence were independent factors associated with long-term
remission and survival.

 

Oral S114:

Title: Efficacy and Safety Outcomes of Obecabtagene Autoleucel (obe-cel)
Stratified by Age in Patients with r/r B-ALL

Session Name: Immunotherapy and CAR-T cells for ALL

Session Room: Coral 6

Session Date and Time: Sunday, June 15; 11:00 - 12:15 CEST

Presenting Author: Bijal D. Shah, MD

 

Summary: Obe-cel treatment was associated with deep and durable remissions
resulting in favorable overall remission rate, event free survival, and
overall survival with low incidence of Grade ≥3 CRS and ICANS in both age
groups (<55 years and ≥55 years). These findings indicate that obe-cel is
effective and has a positive benefit and risk profile regardless of patient
age, including in older adults with R/R B-ALL.

 

Poster PF378:

Title: Predicting Hematotoxicity Risk and Outcomes in Relapsed/Refractory
B-Cell Acute Lymphoblastic Leukemia (r/r B-All): Should Hematotox Models be
CAR Specific Rather than Disease Specific

Session Title: Poster Session 1

Session date and time: Friday, June 13; 18:30 - 19:30 CEST.

Presenting Author: Claire Roddie, MD

 

Summary: Although both the CAR-Hematotox (CAR-HT) model, and the
ALL-Hematotox (ALL-HT) model show potential, ALL-HT appears to improve risk
stratification and may be a better predictor of response, survival and safety
outcomes in adult patients with r/r B-ALL treated with obe-cel, than CAR-HT.
Taken together with other published reports, our data suggest that the
strength of HT-model predictions may be CAR T-cell product specific. Further
analyses are needed.

 

About Autolus Therapeutics plc

Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial-stage
biopharmaceutical company developing, manufacturing and delivering
next-generation T cell therapies and candidates for the treatment of cancer
and autoimmune disease. Using a broad suite of proprietary and modular T cell
programming technologies, Autolus is engineering precisely targeted and
controlled T cell therapies that are designed to better recognize target
cells, break down their defense mechanisms and eliminate these cells. Autolus
has an FDA approved and MHRA licensed product, obe-cel, and 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
(https://www.globenewswire.com/Tracker?data=yWMfoHOQPekv0DybIZOGn8crLIWVequdyO3rwWDrLBQgAlB6xGuoPH1bJOGhZpPVmsWu055QohOuNG5JA5vffzyCaU6cWTedgNrllcutUms=)
.

About obe-cel FELIX clinical trial

Autolus' Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r
B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the
single arm, Phase 2 clinical trial. The primary endpoint in the pivotal cohort
was overall response rate, and the secondary endpoints included duration of
response, MRD negative complete remission 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 .

 

Contact:

 

Amanda Cray

+1 617-967-0207
a.cray@autolus.com
(https://www.globenewswire.com/Tracker?data=hRS98TPfG-8TfKz_XdvQTBGWiGN7-GmBN0Rj_vnKFa573RNgpfD9eXY4H8CtDEHfOqiYkdHpHqwEMb7EydxS-3cigS1rtCgMANbx_TjIBfs=)
 

 

Olivia Manser

+44 (0) 7780 471 568
o.manser@autolus.com
(https://www.globenewswire.com/Tracker?data=Xq1nHIooFKyCKXXLF-bkzOgRRlTzhHnJ84EwJjd4lgB0DD0va-Ly_GBpwN4zjR09UXZxBva9DwxKmwQ2sxLHTa_vBfUfFt4zLnzxQRYwcOU=)
 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCFLLFFEQLXBBZ