Benzinga | Jul 1, 2021 08:12AM EDT

Achilles Therapeutics Reports Enrollment Of First US Patient In Ongoing Phase 1/2a Study In Advanced Non-Small Cell Lung Cancer

- Patient enrolled at the Moffitt Cancer Center, FL where Dr. Benjamin Creelan is the Principal Investigator -

- CHIRON trial is enrolling up to 40 patients with advanced unresectable or metastatic non-small cell lung cancer at clinical sites in the UK, EU and the US -

LONDON, July 01, 2021 (GLOBE NEWSWIRE) -- 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."