REG - Syncona Limited - Achilles presents clinical data update

SynconaAnnouncement

06/12/2022 11:15

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RNS Number : 7428I  Syncona Limited  06 December 2022

 

Syncona Limited

Achilles presents clinical data update

06 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),
presented an encouraging interim Phase I/IIa update on the use of clonal
neoantigen reactive T cells (cNeT) from the CHIRON study in advanced
unresectable or metastatic non-small cell lung cancer (NSCLC) and the THETIS
study in recurrent or metastatic malignant melanoma at the ESMO
Immuno-Oncology Congress 2022 (ESMO IO).

 

·      Achilles has provided further detail on 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 further information presented covers the following key
points:

o Safety and tolerability observations of cNeT compare favorably to standard
tumor infiltrating lymphocytes (TIL) due to less IL-2 related toxicity

o  Durable partial response and stable disease achieved in heavily
pre-treated NSCLC patients dosed with cNeT monotherapy

o  Data has been presented from three patients in the CHIRON trial at the
Process 2 dose level

·     In their release, the company has also noted that it has dosed two
additional patients to the 14 patients since submitting the data to the ESMO
IO Congress: one in CHIRON and one in THETIS Cohort B (checkpoint combination)

·      Achilles will provide further updates from both programmes in
CY2023

 

Martin Murphy, CEO and Chair of Syncona Investment Management Limited, said:
"We note positively that the company has dosed a further two patients since
submitting data to ESMO-IO, expanding the cohorts across the two trials to 16
patients in total. Whilst we are pleased to see the early safety profile of
Achilles' product and a partial durable response, in order for Achilles to be
competitive in the space it is operating, it is critical that the company can
manufacture at scale and we are looking forward to engaging the company
further regarding the optimization of its manufacturing process."

 

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
(https://ir.achillestx.com/events-and-presentations) .

 

The company will host a live webcast and conference call on today 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.

 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 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 Presents Encouraging Phase I/IIa Update on Clonal
Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma at ESMO IO Congress
2022

 

- Early proof-of-concept data support durable clinical benefit including confirmed partial response and stable disease in heavily pre-treated patients with advanced NSCLC -

- Safety and tolerability profile potentially expands opportunity to include patients ineligible for high dose lymphodepletion or high dose IL-2 -

 

- Mechanism of action informed by translational science platform's capability
to correlate cNeT with anti-tumor activity -

 

- Additional monotherapy data and initial anti-PD-1 combination data expected
in 2023 -

 

- Conference call and webcast today at 8:00am ET / 1:00pm UK -

 

London, UK 6 December 2022 - Achilles Therapeutics plc (NASDAQ: ACHL), a
clinical-stage biopharmaceutical company developing AI-powered precision T
cell therapies to treat solid tumors, today presented an encouraging interim
Phase I/IIa update on the use of clonal neoantigen reactive T cells (cNeT)
from the CHIRON study in advanced unresectable or metastatic non-small cell
lung cancer (NSCLC) and the THETIS study in recurrent or metastatic malignant
melanoma at the ESMO Immuno-Oncology Congress 2022 (ESMO IO).

 

"The early safety, tolerability, and durable clinical benefit in heavily
pre-treated patients presented today are encouraging and illustrate the
promising therapeutic potential of cNeT monotherapy. Further, the strength of
our translational science platform was shown by our ability to track key
elements of activity that correlated to cNeT presence," said Dr Iraj Ali, CEO
of Achilles Therapeutics. "We look forward to providing further updates in
2023, including additional monotherapy data from CHIRON and THETIS, and
initial THETIS combination data evaluating cNeT with a PD-1 checkpoint
inhibitor."

 

"The partial response and stable disease observed with low doses of cNeT in
this difficult to treat patient population are encouraging, and coupled with
the well-tolerated safety profile, highlight a favorable therapeutic window to
further dose escalate and help drive deeper, more durable responses," added
Dr. Karl Peggs, Chief Medical Officer of Achilles Therapeutics. "We believe
this is the first time a response in lung cancer has been demonstrated using a
cell therapy with a low dose conditioning and IL-2 regimen, which importantly,
could expand eligibility of this therapy to include patients with
comorbidities or reduced fitness that may not be candidates for traditional
TIL therapy."

 

Dr. Sergio Quezada, Chief Scientific Officer of Achilles Therapeutics added,
"In addition to the durable clinical benefit, our translational science
platform begins to deliver key mechanistic insights for our cNeT therapy that
are not possible with a standard TIL product, including assessment of
phenotypic markers as well as proliferative and cytolytic capacity of the
tumor reactive cNeT component. By virtue of knowing the cNeT targets and being
able to characterize and track specific cNeT in the product and in the blood
of patients, we can monitor cNeT dose, markers of function and exhaustion,
engraftment, activation, and other features related to the patient, product,
and performance in vivo."

 

·    Early, encouraging proof-of-concept data support the potential of
cNeT monotherapy to deliver durable clinical benefit

o  14 patients treated (8 NSCLC in CHIRON, 6 melanoma in THETIS) with median
of two prior lines of therapy

o  Two additional patients dosed since ESMO IO cut-off: one in CHIRON and
one in THETIS Cohort B (checkpoint combination)

·    Confirmed partial response and stable disease achieved with low doses
of cNeT and reduced dose lymphodepletion and IL-2 in NSCLC

o  1 partial response (PR, 56% tumor reduction maintained at week 36) and 6
patients with stable disease (SD) with overall durable clinical benefit at 12
weeks in 71% of evaluable patients (5/7) with advanced NSCLC

o  cNeT driven anti-tumor activity in the partial responder is supported by T
cell engraftment and cytokine profiles

o  Stable disease in 50% of evaluable patients (3/6) with melanoma

o  cNeT product characterization supports a polyfunctional active component

·    Encouraging early safety and tolerability profile for cNeT

o  Safety and tolerability observations of cNeT compare favorably to standard
tumor infiltrating lymphocytes (TIL) due to less IL-2 related toxicity

o  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

o  Reduced dose lymphodepletion and IL-2 may expand patient eligibility
criteria to include those with greater co-morbidities

·    Robust translational science platform correlates cNeT to activity

o  cNeT display an activated and functional phenotype including markers
associated with tissue migration and a transcriptional profile supporting
proliferation and cytotoxic function

o  Effective lymphodepletion and subsequent immune reconstitution were
observed in all patients despite lower doses of lymphodepleting agents

o  Functional activity of cNeT supported by the observation of peak expansion
of cytokine-secreting cNeT 21 days post infusion, coinciding with a peak in
IL-6, with detection of cNeT beyond 12 weeks by TCR analysis

·    Manufacturing process evolution continues to increase cNeT doses

o  78 million median cNeT dose of first Process 2 products (n=3, CHIRON),
with median 17% reactivity

o  47 million median cNeT dose across patient products since last update vs.
14 million in the first eight patients reported at SITC 2021

 

Webcast and Conference Call Details

The company will host a live webcast and conference call today, 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 and a slide presentation will be made available in the Events &
Presentations section of the Company website at
https://ir.achillestx.com/events-and-presentations
(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
(https://register.vevent.com/register/BIdd36937655cc485484a379737c5ece8d) .

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™
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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