Achilles Therapeutics Enrolls First US Patient in Ongoing Phase I/IIa Study in Advanced Non-small Cell Lung Cancer
July 01 2021 - 8:00AM
Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage
biopharmaceutical company developing precision T cell therapies to
treat solid tumors, today announced that the first patient in the
United States (US) has been enrolled in the Company’s ongoing Phase
I/IIa CHIRON clinical trial. CHIRON is an open-label, multi-center
Phase I/IIa trial evaluating the safety, tolerability, and activity
of clonal neoantigen T cell (cNeT) therapy as a single dose in
adult patients with advanced metastatic non-small cell lung cancer
(NSCLC). cNeT are selectively expanded T cells that target a
patient’s own clonal neoantigens which are present on all tumor
cells but absent from healthy tissue.
This first US patient was enrolled at the
Moffitt Cancer Center in Tampa, FL where Dr. Benjamin Creelan is
the Principal Investigator. CHIRON is now open at 10 sites in the
UK, EU and the US.
“We are delighted to have taken our
cutting-edge, cNeT platform into the US with the successful
enrollment of the first patient at the Moffitt Cancer Center in our
ongoing CHIRON study,” said Dr Iraj Ali, CEO of
Achilles Therapeutics. “With our cNeT platform we
prospectively target patient-specific clonal neoantigens and are
able to generate comprehensive characterization including the dose
of the active cNeT component for each product. We look forward to
providing an update from 10 patients across our CHIRON and THETIS
studies in NSCLC and melanoma, respectively, in the fourth quarter
of this year where we will present data highlighting a basis for
our proposed potency assay.”
CHIRON is expected to recruit approximately 40
patients with advanced unresectable or metastatic NSCLC. The
primary objective of the trial is to assess the safety and
tolerability of cNeT. Clinical efficacy will be evaluated as a
secondary measure. Additional data evaluating cNeT persistence,
phenotype, and functionality will be reviewed while also exploring
potential biomarkers of clinical activity and factors affecting
response. This will include analysis of patient samples using a
bespoke plasma ctDNA assay.
“There is still a large unmet need in NSCLC
where there are very limited options for relapsed patients. We at
the Moffitt are pleased to be the first US-based site for the
CHIRON study to evaluate this important, precision
tumor-infiltrating lymphocyte therapy,” said Dr Benjamin C
Creelan, Principal Investigator of the CHIRON
study and thoracic oncologist at Moffitt Cancer
Center. “This is the first US patient to be enrolled to receive a
precision T cell therapy specifically targeting clonal neoantigens
and we are pleased to be working with the team at Achilles.”
About Achilles
TherapeuticsAchilles 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
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.
Forward-Looking StatementsThis
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) 373-2634l.stern@achillestx.com
Consilium Strategic CommunicationsMary-Jane
Elliott, Sukaina Virji, Melissa Gardiner+44 (0) 203 709
5000achillestx@consilium-comms.com
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