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 processSession Name: 711. Cell
Collection and Processing: Advances in Mobilization, Collection,
Manipulation and Engineering of HSCs and T
CellsAbstract: #477Date:
Sunday, December 12, 2021 Session Time: 12:00 PM -
1:30 PM ET; Presentation Time: 12:30 PM
ETLocation: Georgia World Congress Center, Hall
A1Presenter: 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.” 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: #3823Date:
Monday, December 13, 2021 Presentation Time: 6:00
PM - 8:00 PM ETLocation: Georgia World Congress
Center, Hall B5Presenter: 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-ALLSession Title:
703. Cellular Immunotherapies: Basic and Translational: Poster
IAbstract:
#1710Date: Saturday, December 11,
2021Presentation Time: 5:30 PM - 7:30 PM
ETLocation: Georgia World Congress Center, Hall
B5Presenter: 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.” Nature Medicine volume 25,
pages1408–1414(2019) (Sept 25, 2019)
Investor call detailsManagement
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 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
plcAutolus 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 potential
pivotal trial for adult ALL.
About obe-cel
FELIX clinical trialAutolus’ 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 AUTO1/22AUTO1/22 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.
[NCT02443831]
Forward-Looking StatementsThis
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; and expectations regarding the initiation, design and
reporting of data from clinical trials. 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 4, 2021, 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:
Lucinda Crabtree, PhDVice President, Business
Strategy and Planning+44 (0) 7587 372
619l.crabtree@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.comSusan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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