Arix Bioscience PLC (ARIX) Arix Bioscience PLC: Autolus
Therapeutics presents positive obe-cel data at the American Society
of Hematology (ASH) Annual Meeting 2021 13-Dec-2021 / 15:50 GMT/BST
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Arix Bioscience plc
Autolus Therapeutics presents positive obe-cel data at the
American Society of Hematology (ASH) Annual Meeting 2021
LONDON, UK, 13 December 2021: Arix Bioscience plc ("Arix",
LSE:ARIX), a global venture capital company focused on investing in
and building breakthrough biotech companies, notes that its
portfolio company, Autolus Therapeutics plc (Nasdaq: AUTL), today
announced the presentation of new data on obe-cel (AUTO1) and
AUTO1/22 at the American Society of Hematology (ASH) Annual
Meeting, being held between December 11-14, 2021.
At the meeting, Autolus reported the following:
-- Obe-cel shows sustained durability of response with
morphological EFS of 46% at 24 months in the ALLCAR19study
-- Obe-cel response and safety data from the Phase 1b portion of
the FELIX study consistent with the Phase 1ALLCAR19 study
-- Obe-cel achieves a metabolic CR in 100% patients with FL, MCL
and DLBCL, with long term persistenceevident and without ICANS or
high grade CRS
-- Dual targeting AUTO1/22 shows data consistent with high level
of activity and good engraftment
Autolus management held a conference call and webcast earlier
today at 8:00 am ET/1:00 pm GMT to discuss the ASH data. To listen
to the webcast and view the accompanying slide presentation, please
go to the events section of Autolus' website
https://www.autolus.com/
Full text of the announcement from Autolus is contained below
and can also be accessed on Autolus' website.
[ENDS]
For more information on Arix, please contact:
Arix Bioscience plc
+44 (0)20 7290 1050
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil
+44 (0)20 7250 1446
arix@powerscourt-group.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused
on investing in and building breakthrough biotech companies around
cutting-edge advances in life sciences.
We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks o help accelerate their
ideas into important new treatments for patients. As a listed
company, we are able to bring this exciting growth phase of our
industry to a broader range of investors.
www.arixbioscience.com
AUTOLUS PRESS RELEASE
Autolus Therapeutics presents positive obe-cel data at the 63rd
ASH Annual Meeting & Exposition
-- Obe-cel shows sustained durability of response with
morphological EFS of 46% at 24 months in the ALLCAR19study
-- Obe-cel response and safety data from the Phase 1b portion of
the FELIX study consistent with the Phase 1ALLCAR19 study
-- Obe-cel achieves a metabolic CR in 100% patients with FL, MCL
and DLBCL, with long term persistenceevident and without ICANS or
high grade CRS
-- Dual targeting AUTO1/22 shows data consistent with high level
of activity and good engraftment
Conference Call and Webcast to be held Monday, Dec 13, 2021 at
8:00 am ET / 1:00 pm GMT
LONDON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Autolus Therapeutics
plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company
developing next-generation programmed T cell therapies, presented
further progress on obecabtagene autoleucel (obe-cel) in an oral
presentation [Abstract 477] entitled "Industrialization of an
Academic Miltenyi Prodigy-Based CAR T Process" at the 63rd American
Society of Hematology (ASH) Annual Meeting & Exposition, being
held between December 11-14, 2021. The Company also presented an
update of obe-cel in relapsed/refractory aggressive and indolent
B-Cell Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic
Leukaemia (CLL) patients from the ALLCAR19 extension study, as well
as preclinical and initial engraftment data with AUTO1/22 in
Pediatric ALL in two separate poster presentations [Abstracts 3823
and 1710, respectively].
"We continue to observe sustained responses with obe-cel, with
an EFS of 46% at 24 months and patients approaching up to 42 months
of durability in the ALLCAR-19 study, supporting the curative
potential of obe-cel as a standalone therapy in r/r B-ALL patients.
Furthermore, we were encouraged to observe comparable safety and
high complete response data between patients treated in the
academic ALLCAR19 study and those in the Phase 1b portion of the
Autolus sponsored FELIX study," said Dr. Christian Itin, chief
executive officer of Autolus. "In addition, we are excited to
observe further positive data for obe-cel in r/r B-NHL and B-CLL
patients, as well as compelling initial data for AUTO1/22, pointing
to the potential for indication expansion and life cycle management
opportunities longer term."
Obe-cel in Adult Acute Lymphoblastic Leukemia patients (FELIX
study) Oral Presentation Title: Industrialization of an Academic
Miltenyi Prodigy-Based CAR T process Session Name: 711. Cell
Collection and Processing: Advances in Mobilization, Collection,
Manipulation and Engineering of HSCs and T Cells Abstract: #477
Date: Sunday, December 12, 2021 Session Time: 12:00 PM - 1:30 PM
ET; Presentation Time: 12:30 PM ET Location: Georgia World Congress
Center, Hall A1 Presenter: Dr. Claire Roddie, MD, PhD, FRCPath,
Consultant Haematologist and Honorary Senior Lecturer, Cancer
Institute, University College London (UCL)
Initial experience in the phase 1b portion of the FELIX 1b/2
study (NCT04404660) resulted comparable results as seen in the
Phase 1 ALLCAR19 study. As of the cut-off date of 13 September, 16
patients in the Phase 1b part of the FELIX study had received
obe-cel. Patient characteristics in the FELIX 1b portion were
broadly comparable to those observed in the ALLCAR19 study in r/r
adult B-ALL.
-- As of the data cut off date of 15 October 2021, ALLCAR19 data
shows morphological EFS for obe-cel is 46%at 24 months with a
median follow-up of 29.3 months and patients approaching up to 42
months of durability.
-- Baseline characteristics between FELIX Phase 1b and ALLCAR19
studies are similar. 75% patients in theFELIX Phase 1b had >20%
blasts at pre-conditioning, compared with 60% patients in ALLCAR19.
56.3% patients receivedprior blinatumomab in the FELIX Phase 1b
study compared with 25% in ALLCAR191.
-- High level of CR/CRi response rate at 1 month observed across
both studies, with 12/16 patients in theFELIX Phase 1b study,
consistent with 17/201 patients in the ALLCAR19 study.
-- Safety consistent between the ALLCAR19 study and FELIX Phase
1b study, with no patient having high grade(>=Grade 3) cytokine
release syndrome (CRS). 1 of 16 patients experienced a Grade 3
immune effector cell-associatedneurotoxicity syndrome (ICANS) in
the FELIX Phase 1b study, as compared with 3 of 20 patients in
ALLCAR-19 study1.
The company expects to present data from the Phase 2 portion of
the FELIX study in 2022.
1 Roddie et al. "Durable responses and low toxicity after fast
off-rate CD19 CAR-T therapy in adults with relapsed/ refractory
B-ALL." DOI: 10.1200/JCO.21.00917 Journal of Clinical Oncology -
published online before print August 31, 2021
Obe-cel (AUTO1) in Adult Acute Lymphoblastic Leukemia patients
(ALLCAR study) Poster Presentation Title: Safety and Efficacy of
AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell
Non-Hodgkin's Lymphoma (B-NHL) and Chronic Lymphocytic Leukaemia
(CLL) Session Title: 704. Cellular Immunotherapies: Clinical:
Poster III Abstract: #3823 Date: Monday, December 13, 2021
Presentation Time: 6:00 PM - 8:00 PM ET Location: Georgia World
Congress Center, Hall B5 Presenter: Dr. Claire Roddie, MD, PhD,
FRCPath, Consultant Haematologist and Honorary Senior Lecturer,
Cancer Institute, University College London (UCL)
As of the data cut-off date of October 15, 2021, 15 r/r B-NHL
and 1 B-CLL patient had received obe-cel with 14 patients evaluable
for response.
-- 14 of 14 patients responded to obe-cel of which 13 of 14
patients achieved complete metabolic responseper Lugano 2014, with
1 B-CLL patient in PR.
-- 15 of 16 patients were without disease progression at last
follow-up, with 1 of 16 patients having diedin CR from COVID-19.
Furthermore, long term persistence was demonstrated by qPCR.
-- Median follow up time for Follicular Lymphoma (FL) and DLBCL
patients was 11.8 months (range 2-14.2m).
-- Median follow up time for Chronic Lymphocytic Leukemia (CLL)
and Mantle Cell Lymphoma patients was 7.4months (range
1.1-14.8m).
-- Across all patients, obe-cel demonstrated a favorable safety
profile with no ICANS or severe Grade >= 3CRS events.
The company expects to present further data from more B-NHL and
CLL patients in H1 2022.
AUTO1/22 in Pediatric Acute Lymphoblastic Leukemia patients
(CARPALL) Poster Presentation Title: A high sensitivity aCD22 CAR
combined with aCD19 CAR to generate dual targeting CAR T cells for
the treatment of r/r B-ALL Session Title: 703. Cellular
Immunotherapies: Basic and Translational: Poster I Abstract: #1710
Date: Saturday, December 11, 2021 Presentation Time: 5:30 PM - 7:30
PM ET Location: Georgia World Congress Center, Hall B5 Presenter:
Dr. Sara Ghorashian, MD, PhD, Hon clinical senior lecturer, UCL
Great Ormond Street Institute of Child Health
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