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RNS Number : 2302I
Syncona Limited
01 December 2022
Syncona Limited
Achilles to present clinical data update
01 December 2022
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, Achilles Therapeutics Plc
(NASDAQ: ACHL) (Achilles), announced that an abstract highlighting
updated interim results from the ongoing Phase I/IIa CHIRON and
THETIS clinical trials evaluating clonal neoantigen-reactive T
cells (cNeT) has been accepted for a poster presentation at the
ESMO Immuno-Oncology Annual Congress (ESMO IO) taking place in
Geneva, Switzerland from December 7-9, 2022. cNeT are the active
component of the final, precision T cell product which target
tumors through recognition of a patient's clonal neoantigens
present on all tumor cells.
-- Achilles has provided updated data from 14 heavily
pre-treated patients across its Phase I/IIa clinical trials in
advanced non-small cell lung cancer (NSCLC) and recurrent or
metastatic melanoma. The new data to be presented at ESMO
represents six new patients dosed with Achilles' cNeTs
-- Data is reported on eight patients with advanced NSCLC and
six patients in recurrent or metastatic melanoma
-- Safety and tolerability observations of cNeT compare
favorably to standard tumor infiltrating lymphocytes (TIL) due to
less IL-2 related toxicity
-- Durable partial response and stable disease achieved in
heavily pre-treated NSCLC patients dosed with cNeT monotherapy
o The best clinical response was a partial response (ongoing at
week 33) in a NSCLC patient that showed an investigator reported
57% total tumor reduction at week 24, with response ongoing at 33
weeks.
o Stable disease was observed in five NSCLC patients at week 12,
with two patients remaining stable beyond weeks 15 and 26.
Martin Murphy, CEO and Chair of Syncona Investment Management
Limited, said : "Today's data shows that Achilles' therapies have a
positive safety profile to date, and we are pleased to see that
there has been a sustained partial response in a NSCLC patient.
Over the last 12 months, the company has dosed six patients,
including some utilising its higher dose VELOS(TM) Process 2
manufacturing process, demonstrating that the company can
manufacture their products at doses where we believe there is the
potential for meaningful clinical impact. However, it will be
important for us to see further patients dosed in these higher dose
cohorts producing clinical responses and we look forward to seeing
further detail in the presentation at ESMO IO."
The full text announcement from the company is copied below,
while the poster can be accessed on the Events and Presentations
page of the Achilles website:
https://ir.achillestx.com/events-and-presentations .
The company will host a live webcast and conference call on
Tuesday, December 6, 2022, at 8:00am ET / 1:00pm UK to review the
interim update presented at ESMO IO. The live conference call will
be webcast in listen-only mode in the Events & Presentations
section of the Company website at
https://ir.achillestx.com/events-and-presentations. For listeners
who wish to participate in the question-and-answer session via
telephone, please pre-register here.
[S]
Enquiries
Syncona Ltd
Annabel Clay / 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 healthcare businesses, across development stage
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.
Achilles Therapeutics to Present Early Proof of Concept of
Safety and Clinical Activity of Clonal Neoantigen Reactive T Cells
at the ESMO Immuno-Oncology Annual Congress 2022
- Durable partial response (PR) and stable disease (SD) achieved
in heavily pre-treated non-small cell lung cancer (NSCLC) patients
dosed with cNeT monotherapy -
- Updated interim Phase I/II results show encouraging safety and
tolerability profile with potential for deep and durable responses
in NSCLC with cNeT and reduced-dose lymphodepletion and IL-2 -
- Company to host a conference call and webcast on December 6,
2022 at 8:00am ET / 1:00pm UK -
London, UK November 30, 2022 - Achilles Therapeutics plc
(NASDAQ: ACHL), a clinical-stage biopharmaceutical company
developing AI-powered precision T cell therapies to treat solid
tumors, today announced that an abstract highlighting updated
interim results from the ongoing Phase I/IIa CHIRON and THETIS
clinical trials evaluating clonal neoantigen-reactive T cells
(cNeT) has been accepted for a poster presentation at the ESMO
Immuno-Oncology Annual Congress (ESMO IO) taking place in Geneva,
Switzerland from December 7-9, 2022. cNeT are the active component
of the final, precision T cell product which target tumors through
recognition of a patient's clonal neoantigens present on all tumor
cells.
"We are encouraged by the partial response and stable disease we
have seen thus far with our cNeT monotherapy in heavily pre-treated
patients with advanced NSCLC. We believe this supports the
potential for deep and durable clinical responses that can
ultimately help extend overall survival," said Dr Karl Peggs, Chief
Medical Officer of Achilles Therapeutics. "The encouraging safety
and tolerability profile, coupled with reduced dose lymphodepletion
and IL-2 continues to support expanded application to a broader
patient population. We look forward to sharing additional updated
safety, activity, and translational science details at ESMO
IO."
Data on 14 heavily pre-treated patients (eight patients from
CHIRON with advanced NSCLC and six patients from THETIS with
recurrent melanoma) that received cNeT as monotherapy and had
completed at least one post-treatment scan six weeks following
dosing by the abstract cut-off date will be presented. Safety and
tolerability observations of cNeT compare favorably to standard
tumor infiltrating lymphocytes (TIL) due to less IL-2 related
toxicity. Lymphopenia and neutropenia were the most common adverse
events, which are principally associated with the conditioning
regimen, and no dose limiting high-grade toxicities associated with
IL-2 were reported.
The best clinical response was a partial response (ongoing at
week 33) in a NSCLC patient that showed an investigator-reported
57% total tumor reduction at week 24. Translational science
analysis shows that peak expansion of cytokine-secreting cNeT at
day 21 was coincident with signs of systemic immune activation
including increased serum IL-6. Stable disease was observed in five
NSCLC patients through week 12, with two patients remaining stable
beyond weeks 15 and 26. Further characterization of cNeT using
single cell RNA and TCR-seq suggests that cNeT products are
polyclonal, with reactive T cell clusters bearing signatures of T
cell proliferation, cytokine secretion, and tissue migration.
Abstract Details
Title: Early Proof of Concept of Safety and Clinical Activity of
Clonal Neoantigen Reactive Cells (cNeT)
Authors: M. Forster, et al
Session Date and Time: December 7, 2022 from 10:00am CET (Poster
Exhibition, Foyer ABC)
Abstract ID: 179P
Poster Number: 722
An e-poster will be available online on December 6, 2022 at
12:00pm CET (6:00am ET / 11:00am UK) in the meeting program for
conference attendees and in the Events & Presentations section
of the Company website at
https://ir.achillestx.com/events-and-presentations .
Webcast and Conference Call Details
The company will host a live webcast and conference call on
Tuesday, December 6, 2022 at 8:00am ET / 1:00pm UK to review the
interim update presented at ESMO IO. The live conference call will
be webcast in listen-only mode in the Events & Presentations
section of the Company website at
https://ir.achillestx.com/events-and-presentations . For listeners
who wish to participate in the question-and-answer session via
telephone, please pre-register here .
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company
developing AI-Powered precision T cell therapies targeting clonal
neoantigens: protein markers unique to the individual that are
expressed on the surface of every cancer cell. The Company has two
ongoing Phase I/IIa trials, the CHIRON trial in patients with
advanced non-small cell lung cancer (NSCLC) and the THETIS trial in
patients with recurrent or metastatic melanoma. Achilles uses DNA
sequencing data from each patient, together with its proprietary
PELEUS(TM) bioinformatics platform, to identify clonal neoantigens
specific to that patient, and then develop precision T cell-based
product candidates specifically targeting those clonal
neoantigens.
About the CHIRON and THETIS Clinical Trials
CHIRON is an open-label, multi-center Phase I/IIa clinical trial
evaluating the safety, tolerability, and clinical activity of cNeT
therapy as a single dose in adult patients with advanced metastatic
NSCLC. THETIS is an open-label, multi-center Phase I/IIa clinical
trial evaluating the safety, tolerability, and clinical efficacy of
cNeT therapy as a single dose in patients with recurrent or
metastatic malignant melanoma as monotherapy and in combination
with a PD-1 inhibitor.
Forward-Looking Statements
This press release contains express or implied forward-looking
statements that are based on our management's belief and
assumptions and on information currently available to our
management. Although we believe that the expectations reflected in
these forward-looking statements are reasonable, these statements
relate to future events or our future operational or financial
performance, and involve known and unknown risks, uncertainties and
other factors that may cause our actual results, performance, or
achievements to be materially different from any future results,
performance or achievements expressed or implied by these
forward-looking statements. The forward-looking statements in this
press release represent our views as of the date of this press
release. We anticipate that subsequent events and developments will
cause our views to change. However, while we may elect to update
these forward-looking statements at some point in the future, we
have no current intention of doing so except to the extent required
by applicable law. You should therefore not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date of this press release.
Investors:
Achilles Therapeutics
Lee M. Stern, VP, IR & External Communications
l.stern@achillestx.com
LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com
Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
achillestx@consilium-comms.com
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