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RNS Number : 2736S
Syncona Limited
12 November 2021
Syncona Limited
Achilles Presents Data at the Society for Immunotherapy of
Cancer (SITC) Annual Meeting
12 November 2021
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes the announcement that its portfolio company, Achilles
Therapeutics Plc (NASDAQ: ACHL) (Achilles), has announced
additional data from its Phase I/IIa trials in melanoma and
non-small cell lung cancer (NSCLC).
The data is contained in two posters which the company has
presented at the Society for Immunotherapy of Cancer (SITC) Annual
Meeting, demonstrating the ability to detect, quantify, and track
patient-specific clonal neoantigen-reactive T cells (cNeT) and
generate increased cNeT doses from VELOS(TM) Process 2
manufacturing, the company's manufacturing process to generate
higher doses. cNeT target clonal neoantigens, which are unique
targets expressed on every cancer cell within a patient but not on
healthy tissue.
The full text announcement from the company is copied below,
while the posters can be accessed on the Events and Presentations
page of the Achilles website:
https://ir.achillestx.com/events-and-presentations .
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 founding and building a portfolio of global leaders
in life science 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.
Achilles Therapeutics Presents Data at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting Demonstrating the
Ability to Detect, Quantify and Track Patient-specific cNeT and
Significant Increase in cNeT Dose from VELOS(TM) Process 2
Manufacturing
Nov 12 2021
- Conference call and webcast scheduled for today at 8:30am ET /
1:30pm UK -
LONDON, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics
plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company
developing precision T cell therapies to treat solid tumors, today
presented two posters at the Society for Immunotherapy of Cancer
(SITC) Annual Meeting demonstrating the ability to detect,
quantify, and track patient-specific clonal neoantigen-reactive T
cells (cNeT) and generate increased cNeT doses from VELOS(TM)
Process 2 manufacturing. cNeT target clonal neoantigens, which are
unique targets expressed on every cancer cell within a patient but
not on healthy tissue.
Samra Turajlic, MD, PhD, Chief Investigator for Achilles' Phase
I/IIa THETIS trial for metastatic malignant melanoma at the Royal
Marsden NHS Foundation Trust in London, UK, presented Poster 543,
entitled 'Sensitive quantification and tracking of the active
components of a clonal neoantigen T cell (cNeT) therapy: From
manufacture to peripheral circulation' which shows Achilles'
ability to detect, quantify and track patient-specific cNeT pre-
and post-infusion in the ongoing PI/IIa CHIRON and THETIS clinical
trials for non-small cell lung cancer (NSCLC) and metastatic
malignant melanoma, respectively. Joseph Robinson, PhD, Senior
Scientist, Process Development at Achilles Therapeutics, presented
Poster 193, 'The Achilles VELOS(TM) Process 2 boosts the dose of
highly functional clonal neoantigen-reactive T cells for precision
personalized cell therapies' highlighting data from a
proof-of-concept study showing an 18-fold increase in median cNeT
generated from VELOS(TM) Process 2 compared to Process 1.
"The data we presented today continue to illustrate the
differentiated profile of our cNeT product and overall platform
that builds on standard TIL therapy by leveraging clonal neoantigen
targeting to deliver a more precise and potent product," said Dr
Iraj Ali, Chief Executive Officer of Achilles. "The ability to
reliably detect and quantify our active component is a key
differentiator of our world-class technology that is unique in the
field and which we believe will be critical for the successful
development of TIL-based therapies."
Engraftment Kinetics, Quantification and Tracking of cNeT in
CHIRON and THETIS
Data presented from the first eight patients dosed across the
first-in-human PI/IIa CHIRON and THETIS trials confirm the ability
of Achilles' VELOS manufacturing process to generate fit,
polyclonal cNeT that can target multiple cancer neoantigens present
on all tumor cells. Achilles' platform can detect, quantify and
track the patient-specific cNeT during manufacturing and post
patient administration, allowing for extensive product
characterization and immune-monitoring.
At the data cut-off for this presentation, five patients with
melanoma (THETIS) and three patients with NSCLC (CHIRON) had
received their cNeT infusion. The median age of the cohort was 57
years and patients had received a median of 2.5 lines of prior
therapy. 88% (7 of 8) of the cNeT products dosed targeted multiple
clonal neoantigens present on all tumor cells. In these seven
products, the number of individual reactivities ranged from two to
twenty-eight and cNeT were detected in the blood of 71% (5 of 7) of
the patients following infusion at time points up to six weeks post
dosing. Best response in the eight dosed patients was stable
disease in 63% (5 of 8) in this initial, low-dose cohort generated
using VELOS Process 1. The tolerability profile was generally
similar to that of standard TIL products that have not been
enriched for cNeT reactivity, with none of the higher-grade adverse
events more commonly associated with the use of higher doses of
interleukin-2 (IL-2). There were no suspected unexpected serious
adverse reactions reported since the previous update on the first
six patients earlier in 2021. Overall, in the cohort there were
three events of cytokine release syndrome and one ICANS event
deemed to be possibly related to cNeT treatment. A previously
disclosed case of encephalopathy was subsequently deemed unlikely
related to cNeT treatment following an Independent Data Safety
Monitoring Committee review.
"The encouraging data from this low-dose cohort are important as
they show how the Achilles platform can answer potency questions,
gives a first look at mechanism of action in a TIL product, and
adds confidence to now move to higher cell doses," said Dr Samra
Turajlic, THETIS Chief Investigator, Royal Marsden NHS Foundation
Trust, London, UK. "I look forward to exploring higher median doses
from VELOS Process 2 manufacturing that should more predictably be
in the anticipated therapeutic range, based on work done with other
cell therapies. As we move to higher cNeT doses I expect improved
cellular engraftment, both in terms of peak expansion and
durability, and hope to see greater evidence of anti-tumor
activity."
The median cNeT dose in patients in this low-dose, Process 1
cohort was 14.2 million cNeT, which is in line with previous
updates. VELOS Process 1 manufacturing generated doses between 0.1
million and 287 million cNeT. cNeT reactivity, defined as the
percentage of clonal neoantigen-reactive cells in the final dosed
products, ranged from 5% to 77%. As the dataset expands and
matures, these metrics of detection and expansion will be
correlated with product, clinical and genomic characteristics to
determine variables associated with peripheral cNeT dynamics and
clinical response.
VELOS(TM) Process 2 Manufacturing
Achilles' VELOS Process 2 manufacturing generated an 18-fold
increase in cNeT compared to Process 1 in this proof-of-concept
study. The increased cNeT contained multiple polyclonal
reactivities and key phenotypic features associated with high cell
fitness and reduced cell exhaustion. VELOS Process 2 improves upon
Process 1 by introducing additional culture media supplementation
and an expansion-boosting stimulation cocktail during the
co-culture period, without adding any time to the overall
manufacturing process. Complementary GMP scale manufacturing data
from Process 2 will be presented at the ESMO Immuno-Oncology
Congress taking place December 8-11, 2021. This GMP scale
manufacturing is identical to the process for Achilles' clinical
studies and formed the basis of the Company's regulatory
submissions to move the ongoing clinical studies to Process 2.
"We are thrilled to see that our Process 2 generated such a
robust increase in cells while maintaining a highly functional
phenotype and we look forward to treating patients with higher
doses manufactured using VELOS Process 2," said Dr Sergio Quezada,
Chief Scientific Officer of Achilles. "Based on our experience with
other cell therapies, we are confident that Process 2 will deliver
doses able to elicit detectable clinical activity."
Achilles' proprietary potency assay enabled the quantification
of the proportion of tumor reactive cNeT within the expanded TIL
population. Both processes generated CD4+ and CD8+ cells able to
recognize clonal neoantigens. Process 2 delivered a polyclonal
product with a median of five neoantigen reactivities (range 3 to
18) detected per patient. The immunophenotype of cNeT generated by
Process 1 and 2 was largely similar, with the majority of the cells
bearing an effector memory phenotype. Cells generated from both
processes are also functionally similar as determined by their
ability to secrete INF-<GAMMA>, IL-2 and TNF-<ALPHA> in
response to polyclonal stimulus.
Poster presentations are available in the Events &
Presentations section of the Company website.
Webcast and Conference Call Details
The company will host a live webcast and conference call today,
Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to review the
SITC presentations and provide a corporate update. A slide
presentation to accompany today's webcast and conference call will
be available on the webcast and in the Events & Presentations
section of the Company's website. The live webcast can be accessed
in the Events & Presentations section of the Company's website.
The conference call dial-in for investors and analysts are (833)
732-1204 (toll free within the USA), 0800 0288438 (toll free within
the United Kingdom) or (720) 405-2169 (outside the USA) with the
access code 4795875.
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company
developing 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 unresectable
locally advanced and metastatic 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.
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.
Further information:
Lee M. Stern - VP, IR & External Communications
+1 (332) 373-2634
l.stern@achillestx.com
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
achillestx@consilium-comms.com
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END
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