Autolus Therapeutics announces 2022 priorities
10 January 2022 - 11:00PM
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announced its 2022 corporate priorities and
provided guidance.
“We are on track to complete patient recruitment
in the FELIX study of obe-cel in adult ALL patients with the first
data expected around the middle of the year,” said Dr. Christian
Itin, chief executive officer of Autolus. “This study is the key
driver for the Company over the coming months and we are working
diligently to shape the product profile and the commercial strategy
of obe-cel, whilst laying the foundation for progressing our other
differentiated CAR T cell products. We are very excited about the
year ahead, which could be a transformational year for
Autolus.”
Key Anticipated Clinical
Milestones:
- Updates on the FELIX trial, where
Autolus is evaluating obe-cel in r/r adult ALL patients. The trial
is currently enrolling patients into the Phase 2 portion. Autolus
expects data from the Phase 2 trial to be available in 2022
- Updates from the ALLCAR19 extension
trial in patients with r/r B-NHL and CLL and longer-term follow-up
of the fully enrolled r/r adult ALL cohort expected in H1 2022
- Updates on the obe-cel Phase 1
trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022
- Clinical data from the AUTO1/22
CARPALL extension trial in pediatric ALL expected in H1 2022 with
longer follow up in H2 2022
- Updates on the AUTO4 Phase 1 trial
in TRBC1+ Peripheral TCL expected in H1 2022
- Phase 1 trials are expected to be
initiated in H1 2022 with AUTO6NG in Neuroblastoma and AUTO8 in
Multiple Myeloma
Recent Key Updates:
- Obecabtagene autoleucel (obe-cel)
in relapsed / refractory (r/r) adult ALL
- FELIX Study – Autolus continues to
enroll patients in the Phase 2 portion of the FELIX study. The
multi-center study is progressing well. As presented at ASH in
December 2021, the data from the Phase 1b portion of the FELIX
study show a favorable safety and efficacy profile consistent with
our experience in the ALLCAR19 study in adult r/r B-ALL and the
CARPALL study in pediatric r/r ALL patients treated with obe-cel.
No patient experienced high grade (≥ grade 3) cytokine release
syndrome (CRS) and neurotoxicity (ICANS) of any grade was limited
to 13% of patients and only 6% experienced a grade 3 event. The
Company reiterates its expectation of pivotal data in 2022.
- ALLCAR19 Study - Data were
published in the Journal of Clinical Oncology (JCO)(1) in September
2021 from the ALLCAR19 trial in r/r adult ALL patients. Obe-cel
demonstrated a manageable adverse events profile, with no patients
experiencing high grade CRS, despite the majority having a high
disease burden prior to lymphodepletion. As presented at ASH in
December 2021, duration of response remains highly encouraging with
morphological EFS for obe-cel of 46% at 24 months with a median
follow-up of 29.3 months and patients approaching up to 42 months
of durability.
- Obe-cel in r/r B-NHL – ALLCAR19
extension
- The latest data of obe-cel in
relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL) and
Chronic Lymphocytic Leukaemia (CLL) were presented by Autolus at
ASH in December 2021. 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. Across all patients,
obe-cel demonstrated a favorable safety profile with no ICANS or
severe Grade ≥ 3 CRS events.
- In November 2021, Autolus announced
that it had entered into a strategic collaboration and financing
agreement under which Blackstone Life Sciences, a fund managed
by Blackstone (NYSE: BX) will provide up to $250 million in
equity and product financing to support Autolus’ advancement of
obe-cel, as well as next generation product therapies of obe-cel in
B-cell malignancies.
- In September 2021, Autolus gave an
update on its manufacturing strategy, announcing that planning
approval had been granted to build the Company’s new manufacturing
facility in Stevenage, UK. The 70,000 square foot facility is being
built by Merit Holdings Limited as general contractor for the Reef
Group, who will lease the facility to Autolus. Global commercial
launch capacity for obe-cel will initially be provided by the
existing clinical trial manufacturing facility at The Cell and Gene
Therapy Catapult facility, and will then move to the new Autolus
facility, which will allow for approximately 2,000 batches a year
initially, with scope to expand.
- In July 2021, Autolus announced its
entry into an agreement with Moderna, Inc., granting Moderna an
exclusive license to develop and commercialize mRNA-based
therapeutics incorporating Autolus’ proprietary binders for up to
four immuno-oncology targets.
(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
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:
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-212-966-3650susan@sanoonan.com
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