Autolus Therapeutics to Present Four Clinical Data Updates at the European Hematology Association Congress
May 12 2022 - 10:51AM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announces the online publication of four
abstracts submitted to the European Hematology Association (EHA)
Congress to be held June 9-12, 2022. Autolus plans to present more
detail on these programs and the next steps in a conference call
following the EHA presentations, on June 13, 2022, details below.
“We are delighted to be presenting encouraging
early clinical data from four of our pipeline programs, including
important additive safety and efficacy data from our lead asset
obe-cel in indications beyond adult r/r B-ALL. These data
demonstrate the inherent value in both our pipeline and our
technology base from which it originates,” said Dr.
Christian Itin, Chief Executive Officer of Autolus. “With
oral presentations on the early safety, tolerability, feasibility
and preliminary efficacy of AUTO4 and AUTO1/22, we’re in a great
place to evaluate the next strategic steps for these candidates and
further build on the data presented here.”
Abstracts to be presented:
- Title: Safety and preliminary efficacy findings of
AUTO4, a TRBC1-targetting CAR, in relapsed/refractory TRBC1
positive selected T Cell Non-Hodgkin Lymphoma
LINKSession Title: Gene therapy
and cellular immunotherapy - Clinical 2Session date and
time: Saturday, June 11 - 16:30 - 17:45
CESTSession room: Hall Strauss 1-2Final
Abstract Code: S261Presenting Author:
Kate CwynarskiSummary: Peripheral T cell lymphomas
(PTCL) are typically aggressive, treatment resistant, and
associated with poor prognosis. Finding the right target is
challenging because there is a lack of tumor-specific antigens, and
pan-T cell depletion leads to immunosuppression. T cell lymphoma is
clonal, and tumor cells express either TRBC1 or TRBC2. AUTO4
targets TRBC1+ cells, which allows part of the T cell compartment
to be retained. As of 9 February 2022, 9 patients screened for r/r
TRBC1+ peripheral T-cell lymphoma have been treated with AUTO4. Two
patients had prior stem cell transplantation. After lymphodepletion
with Flu/Cy, 3 patients received 25 x 106 CAR T cells, 2 patients
received 75 x 106 CAR T cells, 1 patient received 225 x 106 CAR T
cells and 3 patients received 450 x 106 CAR T cells. AUTO4
demonstrated a tolerable safety profile, with no patient
experiencing any dose limiting toxicities, and no
neurotoxicity/immune effector cell-associated neurotoxicity
(ICANS). Three patients experienced cytokine release syndrome (CRS)
(1 patient with Grade 1, 1 patient with Grade 2 and 1 patient with
Grade 3). Of the 9 patients treated, 5 patients had achieved
complete metabolic responses (CMR) by PET-CT at Month 1, 1 patient
remains with a partial response (PR) 6 months post AUTO4 infusion,
and 3 patients did not respond. All 3 patients at the highest dose
level achieved a CMR at Month 1.
- Title: Dual antigen targeting with
co-transduced CD19/22 CAR T cells for relapsed/refractory ALL
(AUTO1/22) LINKSession
Title: Gene therapy and cellular immunotherapy - Clinical
1Session date and time: Saturday, June 11 - 11:30
- 12:45 CESTSession room: Hall Strauss
1-2Final Abstract Code: S259Presenting
Author: Sara GhorashianSummary: CD19
negative escape is a major cause of relapse after CD19 CAR T cell
therapy for relapsed/refractory (r/r) pediatric ALL. To overcome
this challenge, AUTO1/22 builds on the favorable safety profile and
excellent persistence of obe-cel by combining it with an additional
CD22 targeting CAR. As of 8 February 2022, 10 pediatric ALL
patients have been treated with AUTO1/22 and 8 are evaluable with
>1 month follow-up. 5 of 8 patients had relapsed post allogeneic
stem cell transplant (SCT), 4 had received prior Blincyto and 3 had
relapsed after prior Kymriah. CRS occurred in 7/8 patients (grade 1
n=2, grade 2 n=5), but severe CRS was not seen. 7 of 8 evaluable
patients achieved MRD negative complete response (CR) at 1 month
post infusion. Overall, at a median follow up of 4.8 months, 5/8
patients remain in MRD negative CR at last follow up. The study
results demonstrate that dual CD19/22 targeting CAR T cells
generated by co-transduction show an acceptable safety profile,
with robust expansion/persistence and early efficacy in a heavily
pre-treated cohort. To date with limited follow-up we have not
observed antigen negative relapse but longer follow up is
needed.
- Title: Safety and efficacy findings of AUTO1, a fast
off-rate CD19 CAR, in relapsed/refractory Primary CNS
Lymphoma LINKSession
Title: Poster sessionSession date and
time: Friday, June 10 - 16:30 - 17:45 CESTFinal
Abstract Code: P1460Presenting Author:
Claire RoddieSummary: Relapsed/refractory primary
central nervous system lymphoma (PCNSL) has a median overall
survival of 2-8 months and few therapeutic options. obe-cel (AUTO1)
has previously demonstrated high remission rates, low incidence of
CRS/ICANS and long-term persistence, making it a viable treatment
option for PCNSL. As of 14 February 2022, the CAROUSEL study
enrolled 6 patients with r/r PCNSL where the median prior lines of
treatment was 2. 5 patients were infused with IV AUTO1 and 1
patient with intraventricular AUTO1. Following CAR T infusion,
Grade 1 and 2 CRS affected 1 and 3 patients respectively and any
Grade ICANS was observed in 2 patients with 2 Grade 3 events. AUTO1
engraftment and response was evaluable in 4 patients at 1 month
following iv infusion. 2 of 4 patients had no measurable disease at
2 and 6 months of follow up respectively. AUTO1 showed encouraging
remission rates and excellent CAR T engraftment/expansion in the
blood and CSF. Intraventricular administration was well-tolerated
and showed that AUTO1 has activity via that route in a patient who
failed IV therapy. Additional patients updated biological data and
longer follow up will be presented.
- Title: Safety and efficacy findings of AUTO1, a fast
off-rate CD19 CAR, in relapsed/refractory B-Cell Non-Hodgkin’s
Lymphoma (B-NHL), and chronic Lymphocytic Leukemia (CLL) / Small
Lymphocytic Lymphoma (SLL)
LINKSession Title: Poster
sessionSession date and time: Friday, June 10 -
16:30 - 17:45 CESTFinal Abstract Code:
P1459Presenting Author: Claire Roddie
Summary: obe-cel (AUTO1) has demonstrated an
excellent safety profile in previous trials, with low levels of
CRS/ICANS and long-term engraftment of CAR T cells, making it an
ideal CAR T candidate to evaluate in B-NHL, CLL/SLL. As of 8
February 2022, 19 patients had been infused with AUTO1; 10 with low
grade NHL, 6 with DLBCL and 3 with CLL. Patients treated had
received a median of 3 prior lines of treatment. Grade 1 CRS was
reported in 6/19 and Grade 2 CRS in 3/19. No ICANS was observed in
the B-NHL and CLL cohorts. In the lg-NHL and DCBCL cohorts, 10/10
and 4/5 evaluable patients respectively were in CMR post-treatment.
Responses were ongoing in 9/10 lg-NHL at 12 months and in 4/4 DLBCL
at months 1,3,3 and 6. In the CLL cohort, 2/3 evaluable patients
achieved MRD negative remission in the bone marrow with residual
small volume lymph nodes by CT at 6 and 3 months of follow up
respectively. AUTO1 demonstrated a tolerable safety profile in
patients with r/r B-NHL and CLL despite high disease burden. Early
data shows excellent complete remission rates and CAR
engraftment/expansion. Additional patients, updated data and longer
follow up will be presented.
Conference Call
Management will host a conference call and
webcast on June 13, 2022 at 7:30 am ET/12:30 pm BST to discuss
the EHA 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: 6594553.
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: 6594553.
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 called CARPALL for patients with r/r pediatric ALL.
[NCT02443831]
About AUTO4AUTO4 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 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; 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
471568o.manser@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-917-513-5303susan@sanoonan.com
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