REG - Syncona Limited - Portfolio Update
03/08/2023 12:15
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RNS Number : 2247I Syncona Limited 03 August 2023
Syncona Limited
Autolus reports second quarter 2023 Financial Results and Operational Progress
3 August 2023
Syncona Ltd, a leading healthcare company focused on creating, building and
scaling a portfolio of global leaders in life science, notes that its
portfolio company, Autolus Therapeutics Plc (NASDAQ: AUTL) (Autolus),
announced its operational and financial results for the quarter ended June 30,
2023.
Highlights include:
· The Phase II pivotal FELIX study of obe-cel in
relapsed/refractory (r/r) adult B-Cell acute lymphoblastic leukaemia (B-ALL)
remains on track for a Biologics License Application (BLA) submission to the
US Food & Drug Administration (FDA) by end of 2023, having previously met
its primary endpoint at interim analysis
· Data from the study which were presented at the American Society
of Clinical Oncology (ASCO) conference showed a differentiated safety profile
and a high complete remission rate
· Commercial manufacturing facility on track to commence Good
Manufacturing Practice (GMP) operations in H2 2023 with capacity of
approximately 2,000 batches per annum
· Obe-cel Phase I study in refractory systemic lupus erythematosus
(SLE) to start in early CY2024, extending use of obe-cel into autoimmune
diseases
· Rob Dolski appointed as Chief Financial Officer (CFO)
The announcement can be accessed on Autolus' investor website
at https://www.autolus.com/investor-relations/news/
(https://www.autolus.com/investor-relations/news/) and the full text of the
announcement from Autolus is contained below.
Autolus management will host a conference call today, at 8:30 am EDT/ 1:30 pm
BST, to discuss the company's financial results and provide a general business
update. To listen to the webcast and view the accompanying slide presentation,
please go to: https://www.autolus.com/investor-relations/events/
(https://www.autolus.com/investor-relations/events/)
ENDS
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life. We do this by
creating and building companies to deliver transformational treatments to
patients in areas of high unmet need.
Our strategy is to create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 globally leading life
science businesses, across development stage, modality and therapeutic areas,
for the benefit of all our stakeholders. We focus on developing treatments for
patients by working in close partnership with world-class academic founders
and management teams. Our balance sheet underpins our strategy enabling us to
take a long-term view as we look to improve the lives of patients with no or
poor treatment options, build sustainable life science companies and deliver
strong risk-adjusted returns to shareholders.
Forward-looking statements - this announcement contains certain
forward-looking statements with respect to the portfolio of investments of
Syncona Limited. These statements and forecasts involve risk and uncertainty
because they relate to events and depend upon circumstances that may or may
not occur in the future. There are a number of factors that could cause actual
results or developments to differ materially from those expressed or implied
by these forward-looking statements. In particular, many companies in the
Syncona Limited portfolio are conducting scientific research and clinical
trials where the outcome is inherently uncertain and there is significant risk
of negative results or adverse events arising. In addition, many companies in
the Syncona Limited portfolio have yet to commercialise a product and their
ability to do so may be affected by operational, commercial and other risks.
Autolus Therapeutics Reports Second Quarter 2023 Financial Results and
Operational Progress
- Obe-cel, a potentially transformational treatment for
relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), on
track for a Biologics License Application (BLA) submission to the US Food
& Drug Administration (FDA) by end of 2023
- Pivotal FELIX data at ASCO showed 76% of patients treated with
obe-cel achieved a response (CR/CRi) with very low levels of high-grade CRS
and ICANS
- Commercial manufacturing facility, The Nucleus, on track to commence
Good Manufacturing Practice (GMP) operations in H2 2023 with capacity of
approximately 2,000 batches per annum
- Obe-cel Phase 1 study in refractory systemic lupus erythematosus
(SLE) to start in early 2024
- Rob Dolski appointed as Chief Financial Officer (CFO)
- Conference call to be held today at 8:30 am EDT/1:30 pm BST:
Conference call participants should pre-register using the link at the bottom
of this press release
LONDON, August 03, 2023 - Autolus Therapeutics plc (Nasdaq: AUTL), a
clinical-stage biopharmaceutical company developing next-generation programmed
T cell therapies, today announced its operational and financial results for
the quarter ended June 30, 2023.
"We had a successful ASCO conference this quarter, with topline data
presentation for obe-cel from the FELIX study highlighting low levels of
immunotoxicity combined with a high complete remission rate and excellent CAR
T expansion and persistence in adult patients with relapsed/refractory ALL.
The attractive clinical profile driven by the unique CAR design combined with
robust and reliable manufacturing have been the foundation for the successful
outcome of the FELIX study," commented Dr. Christian Itin, Chief Executive
Officer of Autolus. "The Company is now focused on delivering a BLA filing to
the US FDA by year end and the initial preparatory activities for a commercial
launch in 2024, pending the necessary regulatory approvals."
"We have also advanced our preparations for a US commercial launch, selecting
Cardinal Health as our distribution partner and by putting into place the team
that will initiate onboarding of treatment centers in the second half of this
year. With our commercial manufacturing facility, The Nucleus, on track to
commence Good Manufacturing Practice (GMP) operations in the second half of
2023, we are in a strong position to operationally deliver product and
adequately meet the global demand for adult ALL treatment."
"Looking beyond ALL and building on the pioneering work by Georg Schett and
Andreas Mackensen at the University of Erlangen, we believe obe-cel's
excellent safety profile and high level of activity in ALL and NHL patients,
combined with our operational infrastructure, forms an attractive basis for
development of obe-cel in autoimmune disease with a start of first clinical
trial in early 2024."
Key obe-cel Updates:
· Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r)
adult ALL - The FELIX Study
o Pivotal Phase 2 data presented at ASCO and EHA confirmed attractive product
profile with potential best-in-class tolerability and very low levels of
high-grade CRS and ICANS. Longer term follow up data and subgroup analysis
data to be presented at ASH in late 2023, as well as at medical conferences in
H1 2024. BLA submission for obe-cel on-track to be submitted to the FDA at the
end of 2023.
Obe-cel trials in collaboration with University College London
· Obe-cel in r/r adult ALL patients - Phase 1 ALLCAR19 Study
o Long term follow-up data were presented at the Tandem Meetings:
Transplantation & Cellular Therapy Meetings of the American Society for
Transplantation and Cellular Therapy (ASTCT) and the Center for International
Blood & Marrow Transplant Research (CIBMTR). The data demonstrated that
35% of adult ALL patients remained in complete remission at a median follow up
of 36 months without the need for additional anti-leukemia therapy.
· Obe-cel in r/r B-NHL and CLL patients - Phase 1 ALLCAR19 Extension
Study
o Data presented at the ASH meeting in December 2022 demonstrated the
potentially best-in-class profile of obe-cel supported by the data observed in
B-cell non-Hodgkin lymphoma (NHL), with continued high levels of clinical
activity paired with an encouraging tolerability profile across diffuse large
B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL)
and chronic lymphocytic leukemia (CLL). Patients continue to be enrolled into
the study and the Company expects to publish the full results in a
peer-reviewed journal.
· Obe-cel in Primary CNS Lymphoma patients - Phase 1 CAROUSEL Study
o Data presented at the EHA meeting in June 2022 demonstrated first activity
in primary CNS lymphoma. The study is fully enrolled, and the Company expects
to publish the full results in a peer-reviewed journal.
· AUTO1/22 in pediatric B-ALL patients - Phase 1 CARPALL Study
o Data presented at the European Society for Blood and Marrow
Transplantation (EBMT) Annual Meeting in April 2023 by the Company's UCL
collaborators, showed favorable safety profile and good efficacy in a heavily
pre-treated cohort of patients. Importantly, there were no observed antigen
negative relapses observed as of the data cut-off date, indicating that the
combining of our optimized CD22 CAR design with the CD19 CAR used in obe-cel
may be effective in preventing antigen-loss driven relapse in pediatric B-ALL.
The preclinical data supporting this program was published in Molecular
Therapy in March 2023, entitled 'Dual targeting of CD19 and CD22 against B-ALL
using a novel high sensitivity aCD22 CAR.'
Early-stage pipeline - leveraging academic collaborations / opportunity for
non-dilutive funding
· AUTO4 in Peripheral T Cell Lymphoma patients - Phase 1/2 LibrA T1
Study
o Data presented at the International Conference on Malignant Lymphoma (ICML)
in an oral presentation titled 'First in Human Study of AUTO4, a
TRBC1-Targetting CAR T Cell Therapy in Relapsed/Refractory TRBC1-Positive
Peripheral T-Cell Lymphoma' demonstrated safety with no dose limiting
toxicities and remarkable durability in 2 out of 4 responding patients at the
highest dose level tested, with ongoing complete metabolic responses (CMR) in
two r/r PTCL patients at 15 and 18 months.
· AUTO8 in Multiple Myeloma - Phase 1 MCARTY Study
o AUTO8 is a next-generation product candidate for multiple myeloma, which
comprises two CARs for the multiple myeloma targets, BCMA and CD19. In
collaboration with UCL, the Company initiated a study in Q1 2022. Patients
continue to be enrolled and initial data is expected by the end of 2023.
· AUTO6NG in Neuroblastoma
o AUTO6NG contains a CAR that targets GD2 alongside additional programming
modules to enhance the activity and persistence. In collaboration with UCL,
the Company is planning on initiating a clinical trial of AUTO6NG in 2023.
Key Operational Updates during Q2 2023
· The Company's new 70,000 square foot commercial manufacturing
facility, The Nucleus, in Stevenage, UK has continued to progress on track.
Key equipment installation and validation were completed by Autolus in Q1
2023, enabling operational engineering trials to commence in Q2 2023.
Activities are on track for the commencement of further BLA enabling GMP
operations in the second half of 2023. The facility has been designed to
manufacture and test approximately 2,000 batches per year with expansion
opportunities.
· Autolus is on schedule to complete the development work and report
generation for the Chemistry Manufacturing and Controls (CMC) package planned
to be submitted to the FDA. All work including process qualification
activities in The Nucleus is on track for submission of a BLA by the end of
2023.
· Autolus has selected Cardinal Health to provide core distribution
capabilities required for US commercialization of CAR T-cell therapies. Under
the proposed agreement, Cardinal Health 3PL Services will establish essential
capabilities for Autolus to commercialize a CAR T-cell therapy in the US,
including a depot model that allows Autolus to maintain custody and physically
position product closer to treatment sites during the finalization of product
release, with the goal of shortening vein-to-delivery times. In addition,
Cardinal Health will help provide seamless order-to-cash capabilities.
· Autolus hosted a Virtual Capital Markets Day in April 2023, where
members of the Executive Management Team and Key Opinion Leaders presented on
the obe-cel commercial opportunity and positioning. A replay
(https://edge.media-server.com/mmc/p/eqkenav8) of the event is available on
the Autolus website.
· Appointment of Dr. Robert Iannone, Executive Vice President, Global
Head of Research & Development of Jazz Pharmaceuticals plc, as a
Non-Executive Director to Autolus' Board of Directors, effective June 15,
2023.
Scientific Publications:
· Publication of a paper in Molecular Therapy Nucleic Acids, titled
'Novel Fas-TNFR chimeras that prevent Fas ligand-mediated kill and
signal synergistically to enhance CAR T-cell efficacy'. The paper outlined
how Fas-CD40 chimera can render T cell therapies resistant to FasL-mediated
cell death and improve their effectiveness against solid tumors. Link
(https://www.cell.com/molecular-therapy-family/nucleic-acids/fulltext/S2162-2531(23)00103-8)
to paper.
· Publication of a paper in Cancer Immunology Research entitled
'Enhancing CAR T cell therapy using Fab-Based Constitutively Heterodimeric
Cytokine Receptors' highlighting that for CAR T cells to be effective, they
must engraft in the patient, expand to sufficient numbers and persist at the
site of disease. Link
(https://aacrjournals.org/cancerimmunolres/article/doi/10.1158/2326-6066.CIR-22-0640/727849/Enhancing-CAR-T-cell-Therapy-Using-Fab-Based)
to paper.
Post Period Update:
· Post period the Company announced the following appointments:
o Rob Dolski as Chief Financial Officer, effective August 7, 2023. Rob is
succeeding Dr. Lucinda Crabtree. Most recently Rob completed the successful
sale of Checkmate Pharmaceuticals to Regeneron and had prior leadership and
operational roles at Moderna, Human Genome Sciences and Amgen.
o Dr. Veronica Hersberger as Senior Vice President, Medical Affairs. Most
recently Veronica served as Chief Medical Officer of TargImmune Therapeutics
AG. Prior to that she was Global Product Leader for the cancer therapies
Calquence and Lumoxiti at AstraZeneca and led Medical Affairs for the
Hematology Franchise at Roche where she was also involved in the development
of a range of oncology programs.
o Miranda Neville was promoted to Senior Vice President Program Management.
Miranda successfully ran the commercial manufacturing facility project
resulting in the Nucleus site and took over the obe-cel program lead in 2023.
Prior to joining Autolus, Miranda, amongst other roles, led program management
for the Benlysta program at Human Genome Sciences in systemic lupus
erythematosus (SLE) through a successful BLA process, resulting in regulatory
approval.
Financial Results for the Second Quarter Ended June 30, 2023
Cash and cash equivalents and restricted cash at June 30, 2023, totaled $307.8
million, as compared to cash and cash equivalents and restricted cash of
$382.8 million at December 31, 2022.
Total operating expenses, net for the three months ended June 30, 2023, were
$47.9 million, as compared to net total operating expenses, net of $46.5
million, for the same period in 2022.
Research and development expenses decreased by $1.5 million to $36.7 million
for the three months ended June 30, 2023 from $38.2 million for the three
months ended June 30, 2022 primarily due to:
· a decrease of $5.9 million in clinical costs and manufacturing costs
primarily relating to our obe-cel clinical product candidate,
· a decrease of $0.6 million in legal fees and professional consulting
fees in relation to our research and development activities,
· a decrease of $0.5 million in depreciation and amortization related
to property, plant and equipment and intangible assets,
· a decrease of $0.1 million in material transportation costs, offset
by
· an increase of $3.0 million in salaries and other employment related
costs including share-based compensation expense, which was mainly driven by
an increase in the number of employees engaged in research and development
activities,
· an increase of $1.7 million in facilities costs related to our new
manufacturing facility, The Nucleus, in Stevenage, United Kingdom as well as
increases in costs related to maintaining our current leased properties, and
· an increase of $0.9 million related to information technology
infrastructure and support for information systems related to the conduct of
clinical trials and manufacturing operations.
General and administrative expenses increased by $2.8 million to $11.1 million
for the three months ended June 30, 2023 from $8.3 million for the three
months ended June 30, 2022 primarily due to:
· an increase of $1.5 million in commercial readiness costs due to
increased commercial readiness activities being undertaken,
· an increase of $1.2 million in salaries and other employment related
costs including share-based compensation expenses, which was mainly driven by
an increase in the number of employees engaged in general and administrative
activities,
· an increase of $0.2 million related to information technology
infrastructure and support for information systems related to the conduct of
corporate and commercial operations,
· an increase of $0.1 million in depreciation and amortization related
to property and equipment and intangible assets, offset by
· a decrease of $0.2 million primarily related to a reduction in
directors' and officers' liability insurance premiums, legal and professional
fees.
Other income (expense), net increased to an income of $0.5 million for the
three months ended June 30, 2023 from an expense of $1.3 million for the three
months ended June 30, 2022. The increase of $1.8 million is primarily due to
the strengthening of the Pound Sterling exchange rate relative to the U.S.
dollar for the three months ended June 30, 2023 as compared to the three
months ended June 30, 2022.
Interest income increased to $3.4 million for the three months ended June 30,
2023, as compared to $0.1 million for the three months ended June 30, 2022.
The increase in interest income of $3.3 million primarily relates to increased
account balances and yield associated with our cash and cash equivalents
during the three months ended June 30, 2023 as compared to the three months
ended June 30, 2022.
Interest expense increased to $5.0 million for the three months ended June 30,
2023 as compared to $1.8 million for the three months ended June 30, 2022.
Interest expense is primarily related to the liability for future royalties
and sales milestones, net associated with our strategic collaboration
agreement with Blackstone.
Income tax benefit decreased by $4.0 million to $3.5 million for the three
months ended June 30, 2023 from $7.5 million for the three months ended
June 30, 2022 due to a decrease in qualifying research and development
expenditures and the reduction in effective tax rate related to the U.K.
research and development tax credit regime under the scheme for SMEs.
Net loss attributable to ordinary shareholders was $45.6 million for the three
months ended June 30, 2023, compared to $42.1 million for the same period in
2022. The basic and diluted net loss per ordinary share for the three months
ended June 30, 2023, totaled $(0.26) compared to a basic and diluted net loss
per ordinary share of $(0.46) for the three months ended June 30, 2022.
Autolus estimates that its current cash and cash equivalents on hand and
anticipated future milestone payment from Blackstone will extend the Company's
runway into 2025.
Unaudited Financial Results for the Second Quarter Ended June 30, 2023
Condensed Consolidated Balance Sheet
(In thousands, except share and per share amounts)
June 30 December 31
2023 2022
Assets
Current assets:
Cash and cash equivalents $ 307,500 $ 382,436
Restricted cash 332 325
Prepaid expenses and other current assets 47,533 43,010
Total current assets 355,365 425,771
Non-current assets:
Property and equipment, net 36,857 35,209
Prepaid expenses and other non-current assets 295 2,176
Operating lease right-of-use assets, net 54,251 23,210
Long-term deposits 1,864 1,832
Deferred tax asset 2,360 2,076
Total assets $ 450,992 $ 490,274
Liabilities and shareholders' equity
Current liabilities:
Accounts payable $ 3,878 $ 531
Accrued expenses and other liabilities 30,954 40,797
Operating lease liabilities, current 6,231 5,038
Total current liabilities 41,063 46,366
Non-current liabilities:
Operating lease liabilities, non-current 44,707 19,218
Liability related to future royalties and sales milestones, net 135,764 125,900
Other long term payables 122 116
Total liabilities 221,656 191,600
Shareholders' equity:
Ordinary shares, $0.000042 par value; 290,909,783 authorized as of June 30, 8 8
2023 and December 31, 2022; 173,680,872 and 173,074,510 shares issued and
outstanding at June, 2023 and December 31, 2022
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and - -
outstanding at June 30, 2023 and December 31, 2022
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued 118 118
and outstanding at June 30, 2023 and December 31, 2022
Deferred C shares, £0.000008 par value; 1 share authorized, issued and - -
outstanding at June 30, 2023 and December 31, 2022
Additional paid-in capital 1,012,709 1,007,625
Accumulated other comprehensive loss (27,957) (38,898)
Accumulated deficit (755,542) (670,179)
Total shareholders' equity 229,336 298,674
Total liabilities and shareholders' equity $ 450,992 $ 490,274
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2023 2022 2023 2022
Grant income $ - $ - $ - $ 166
License revenue - - 1,292 -
Operating expenses:
Research and development (36,742) (38,212) (68,086) (72,175)
General and administrative (11,122) (8,269) (20,406) (16,256)
Loss on disposal of property and equipment (23) - (3,791) -
Total operating expenses, net (47,887) (46,481) (90,991) (88,265)
Other income (expenses), net 482 (1,331) 1,264 (471)
Interest income 3,403 89 6,849 117
Interest expense (5,020) (1,810) (9,925) (3,599)
Total other expense, net (1,135) (3,052) (1,812) (3,953)
Net loss before income tax (49,022) (49,533) (92,803) (92,218)
Income tax benefit 3,470 7,474 7,440 13,098
Net loss attributable to ordinary shareholders (45,552) (42,059) (85,363) (79,120)
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 5,300 (17,485) 10,941 (24,941)
Total comprehensive loss $ (40,252) $ (59,544) $ (74,422) $ (104,061)
Basic and diluted net loss per ordinary share $ (0.26) $ (0.46) $ (0.49) $ (0.87)
Weighted-average basic and diluted ordinary shares 173,860,491 90,931,964 173,843,249 90,923,119
Conference Call
Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST
to discuss the company's financial results and provide a general business
update. Conference call participants should pre-register using this link
(https://register.vevent.com/register/BI8d4bf0158df6467998c25614214b8901) to
receive the dial-in numbers and a personal PIN, which are required to access
the conference call.
A simultaneous audio webcast and replay will be accessible on the events
section (https://www.autolus.com/investor-relations/news-and-events/events) of
Autolus' website.
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 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 pivotal trial for adult
ALL.
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel enrolled 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 enrolled over
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 and
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 (https://clinicaltrials.gov/ct2/show/NCT02443831)
]
About AUTO4
AUTO4 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.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical development for
T cell lymphoma, a setting where there are currently no approved programmed T
cell therapies. AUTO5 is specifically designed to target TRBC2 derived
cancers, which account for approximately 60% of T cell lymphomas, and is a
complement to the AUTO4 T cell product candidate currently in clinical
development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate in
pre-clinical development. AUTO6NG builds on preliminary proof of concept data
from AUTO6, a CAR targeting GD2-expression cancer cell currently in clinical
development for the treatment of neuroblastoma. AUTO6NG incorporates
additional cell programming modules to overcome immune suppressive defense
mechanisms in the tumor microenvironment, in addition to endowing the CAR T
cells with extended persistence capacity. AUTO6NG is currently in
pre-clinical development for the potential treatment of both neuroblastoma and
other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple myeloma which
comprises two independent CARs for the multiple myeloma targets, BCMA and
CD19. We have developed an optimized BCMA CAR which is designed for improved
killing of target cell that express BCMA at low levels. This has been combined
with fast off rate CD19 CAR from obe-cel. We believe that the design of AUTO8
has the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in development.
Forward-Looking Statements
This 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 the development of
Autolus' product candidates, the status of clinical trials (including, without
limitation, expectations regarding the data that is being presented, the
expected timing of data releases and development, as well as completion of
clinical trials) and development timelines for the Company's product
candidates. 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
COVID-19 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 7, 2023,
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 430877
j.wilson@autolus.com (mailto:j.wilson@autolus.com)
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com (mailto:susan@sanoonan.com)
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. END PFUUOAKROOUWRRRRecent news on Syncona
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