REG - Syncona Limited - Autolus to present clinical data at EHA Congress

SynconaAnnouncement

12/05/2022 16:15

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RNS Number : 3367L  Syncona Limited  12 May 2022

Syncona Limited

 

Autolus to present clinical data updates at EHA Congress

 

12 May 2022

 

Syncona Ltd, a leading healthcare company focused on founding, building and
funding global leaders in life science, notes that its portfolio company,
Autolus Therapeutics Plc (Nasdaq: AUTL) ("Autolus"), has today announced that
new data highlighting progress across its broader portfolio will be presented
at the European Hematology Association (EHA) Congress, held between 9-12 June,
2022. A copy of the announcement is set out below, with key highlights as
follows:

 

·      Positive early safety and efficacy data from AUTO4 in T cell
lymphoma (TCL), with AUTO 4 demonstrating a tolerable safety profile.  5 out
of the 9 patients achieved complete metabolic responses (CMR) one month post
treatment, including all 3 patients treated at the highest dose level.

·      Promising early safety and efficacy data in the AUTO1/22
programme in paediatric acute lymphoblastic leukaemia (pALL), with 5 out of 8
evaluable patients remaining in minimal residual disease (MRD) negative
complete response (CR) at a median follow up of 4.8 months post treatment.

·      Early safety and efficacy data in AUTO1 (obe-cel) in
relapsed/refractory primary central nervous system lymphoma (PCNSL) from 6
patients.

·      Early safety and efficacy findings in obe-cel in
relapsed/refractory B cell non-Hodgkin's lymphoma (B-NHL), and chronic
lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), in 19 patients
in total, with obe-cel showing a tolerable safety profile despite high disease
burden amongst patients, along with excellent CR rates.

 

Autolus will present more detail on these programmes and next steps in their
development in a webcast following the EHA presentations.

 

Martin Murphy, Chief Executive Officer of Syncona Investment Management
Limited, said: "We continue to be highly encouraged by the progress across
Autolus' broader clinical pipeline as it progresses towards a meaningful
read-out from its lead programme, obe-cel, in adult ALL in the second half of
this year. The early clinical data which will be presented at EHA underlines
the strong safety and efficacy profile of Autolus' range of therapies, further
supporting the value of the company's technology. We look forward to seeing
further follow-up data from the company as it progresses its pipeline of
programmes, in order to provide treatments for patients suffering from a range
of B and T cell cancers."

 

 ENDS 

 

Copies of this press release and other corporate information can be found on
the company website at: www.synconaltd.com (http://www.synconaltd.com)

 

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 risk

 

 

Enquiries

 

Syncona Ltd

 

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 7714 916615

 

FTI Consulting

 

Ben Atwell / Julia Bradshaw / 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
founding and building companies to deliver transformational treatments to
patients in areas of high unmet need.

 

Our strategy is to found, build and fund companies around exceptional science
to create a diversified portfolio of 15-20 globally leading healthcare
businesses 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.

 

Autolus Therapeutics to Present Four Clinical Data Updates at the European
Hematology Association Congress

 

-     AUTO4: oral presentation on initial clinical experience in
peripheral T cell lymphoma

-     AUTO1/22: oral presentation on initial experience in r/r pediatric
B-cell acute lymphoblastic leukemia

-     obe-cel: poster presentation in r/r primary CNS lymphoma

-     obe-cel: poster presentation in r/r B-non-Hodgkins lymphoma and
chronic lymphoblastic leukemia

-     Conference call to be held on June 13, 2022 at 7:30 am EST/12:30 pm
BST

-

 

LONDON, May 12, 2022 -- 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:

 

1.   Title: Safety and preliminary efficacy findings of AUTO4, a
TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive selected T Cell
Non-Hodgkin Lymphoma LINK
(https://library.ehaweb.org/eha/2022/eha2022-congress/357125/kate.cwynarski.safety.and.preliminary.efficacy.findings.of.auto4.a.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dauto4)

Session Title: Gene therapy and cellular immunotherapy - Clinical 2

Session date and time: Saturday, June 11 - 16:30 - 17:45 CEST

Session room: Hall Strauss 1-2

Final Abstract Code:  S261

Presenting Author: Kate Cwynarski

Summary: 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 10(6) CAR T cells, 2
patients received 75 x 10(6) CAR T cells, 1 patient received 225 x 10(6) CAR T
cells and 3 patients received 450 x 10(6) 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.

 

2.   Title: Dual antigen targeting with co-transduced CD19/22 CAR T cells
for relapsed/refractory ALL (AUTO1/22) LINK
(https://library.ehaweb.org/eha/2022/eha2022-congress/357123/sara.ghorashian.dual.antigen.targeting.with.co-transduced.cd19.22.car.t.cells.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dauto1%2F22)

Session Title: Gene therapy and cellular immunotherapy - Clinical 1

Session date and time: Saturday, June 11 - 11:30 - 12:45 CEST

Session room: Hall Strauss 1-2

Final Abstract Code:  S259

Presenting Author: Sara Ghorashian

Summary: 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.

 

3.   Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR,
in relapsed/refractory Primary CNS Lymphoma LINK
(https://library.ehaweb.org/eha/2022/eha2022-congress/358317/claire.roddie.safety.and.efficacy.findings.of.auto1.a.fast-off.rate.cd19.car.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dauto1)

Session Title: Poster session

Session date and time: Friday, June 10 - 16:30 - 17:45 CEST

Final Abstract Code:  P1460

Presenting Author: Claire Roddie

Summary: 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.

 

4.   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) LINK
(https://library.ehaweb.org/eha/2022/eha2022-congress/358316/claire.roddie.safety.and.efficacy.findings.of.auto1.a.fast-off.rate.cd19.car.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3Dauto1)

Session Title: Poster session

Session date and time: Friday, June 10 - 16:30 - 17:45 CEST

Final Abstract Code:  P1459

Presenting 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
(https://www.autolus.com/investor-relations/news-and-events/events) 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 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 (http://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 called CARPALL 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.  AUTO4 has been tested in a Phase 1 clinical trial, LibRA1 for
patients with peripheral T cell Lymphoma.

 

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 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 471568

o.manser@autolus.com (mailto:o.manser@autolus.com)

 

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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