REG-Arix Bioscience PLC Arix Bioscience PLC: Autolus Therapeutics presents positive obe-cel data at the American Society of Hematology (ASH) Annual Meeting 2021
13/12/2021 15:55
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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
Dissemination of a Regulatory Announcement, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
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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 ALLCAR19 study
• Obe-cel response and safety data from the Phase 1b portion of the
FELIX study consistent with the Phase 1 ALLCAR19 study
• Obe-cel achieves a metabolic CR in 100% patients with FL, MCL and
DLBCL, with long term persistence evident 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 1 events section of Autolus' website 2 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
3 ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil
+44 (0)20 7250 1446
4 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. 5 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 ALLCAR19 study
• Obe-cel response and safety data from the Phase 1b portion of the
FELIX study consistent with the Phase 1 ALLCAR19 study
• Obe-cel achieves a metabolic CR in 100% patients with FL, MCL and
DLBCL, with long term persistence evident 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 the FELIX Phase 1b had >20% blasts at
pre-conditioning, compared with 60% patients in ALLCAR19. 56.3%
patients received prior 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 the FELIX 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-associated neurotoxicity 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." 6 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 response per 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 died in 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 7.4 months (range 1.1-14.8m).
• Across all patients, obe-cel demonstrated a favorable safety profile
with no ICANS or severe Grade >= 3 CRS 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
Obe-cel had previously been tested in r/r pediatric B-ALL2 in the CARPALL
Study. Whilst obe-cel was safe and effective, similar to other studies in
pediatric B-ALL, antigen escape was a common cause of treatment failure.
AUTO1/22 has been designed to address antigen escape by the co-expression
of a CD22 CAR with the CD19 CAR in obe-cel. Pre-clinical data demonstrated
a high level of in vitro and in vivo activity of AUTO1/22 against leukemia
cells. AUTO1/22 was shown to control leukemia in a mouse model of CD19
negative escape. AUTO1/22 is currently being tested in a study of r/r
pediatric B-ALL. As of the cut-off date of October 21, 2021, 6 patients
had received AUTO1/22. All patients showed engraftment of single and
double CAR positive populations, pointing to early CAR T cell persistence.
We expect to present clinical data from the full cohort of patients in H1
2022.
2 Ghorashian et al. "Enhanced CAR T cell expansion and prolonged
persistence in pediatric patients with ALL treated with a low-affinity
CD19 CAR." 7 Nature Medicine volume 25, pages1408-1414(2019) (Sept 25,
2019)
Investor call details
Management will host a conference call and webcast on Monday, December 13,
2021 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 8 events section of Autolus' website.
The call may also be accessed by dialing (866) 679-5407 for U.S. and
Canada callers or (409) 217-8320 for international callers. Please
reference conference ID 9036269. After the conference call, a replay will
be available for one week. To access the replay, please dial (855)
859-2056 for U.S. and Canada callers or (404) 537-3406 for international
callers. Please reference conference ID 9036269.
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 9 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 obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling 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
is designed to enroll approximately 100 patients across 30 of the leading
academic and non-academic centers in the United States, United
Kingdom and Europe. NCT04404660
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 for patients
with r/r pediatric ALL. [ 10 NCT02443831]
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ISIN: GB00BD045071
Category Code: PFU
TIDM: ARIX
LEI Code: 213800OVT3AHQCXNIX43
OAM Categories: 3.1. Additional regulated information required to be
disclosed under the laws of a Member State
Sequence No.: 129881
EQS News ID: 1257298
End of Announcement EQS News Service
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