ACHL Achilles Therapeutics PLC

Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today presented a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021, which is being held in a virtual format from June 4-8, 2021. The poster presentation given by Dr Mariam Jamal-Hanjani, scientific investigator for CHIRON and Medical Oncologist from the Cancer Research UK Lung Cancer Centre of Excellence, highlights the design of the ongoing phase I/IIa CHIRON clinical trial evaluating clonal neoantigen T cells (cNeT) in patients with advanced non-small cell lung cancer (NSCLC).

The primary objective of the trial is to assess the safety and tolerability of cNeT as monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor, and will also evaluate the clinical efficacy 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.

“With 75% of patients with NSCLC presenting with inoperable or metastatic disease and a 5-year survival for stage IV disease as low as 5%, additional treatments are needed for this large patient population including autologous cell therapies like Achilles’ cNeT,” commented Dr Jamal-Hanjani. “The rationale of the CHIRON trial is very evident as we know that NSCLC patients with tumors that have a high burden of clonal neoantigens have improved disease free survival and increased sensitivity to checkpoint inhibition.”

“Just as with our THETIS melanoma trial, CHIRON allows us to look at the safety and tolerability of our precision cNeT as monotherapy and in combination with a checkpoint inhibitor,” said Dr Karl Peggs, Chief Medical Officer of Achilles. “While the primary purpose of the trials is safety, the addition of these checkpoint combination cohorts will allow further examination of T cell kinetics and the contribution of cell dose and checkpoint therapy to treatment outcomes. Further, we will continue to look at the predictive value of ctDNA as a potential marker for clinical events as we look towards the future of our product with potential companion diagnostics in addition to our planned potency assays.”

All patients enrolled in CHIRON will have been treated with at least one prior systemic therapy, inclusive of a checkpoint inhibitor unless contraindicated, have Eastern Cooperative Oncology Group (ECOG) Status 0-1, have locally advanced or metastatic disease, and have accessible sites for collection of adequate tissue. Patients requiring regular immunosuppression (including steroids at a dose equivalent to prednisolone 10 mg/day or greater) or that have previously received any investigational cell or gene therapies are not eligible.

Details of the abstract and poster presentation are as follows:

Abstract Title: An open-label, multicenter phase I/IIa study evaluating the safety and clinical activity of clonal neoantigen reactive T cells in patients with advanced non-small cell lung cancer (CHIRON)Poster Number: TPS9138Poster Session: Lung Cancer—Non-Small Cell MetastaticThe poster accompanied by a recording from Dr Jamal-Hanjani and full session details are available at www.asco.org. The poster is also available in the Events & Presentations section of the Achilles website at https://ir.achillestx.com/events-and-presentations.

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, Matthew Cole, Sukaina Virji, Melissa Gardiner+44 (0) 203 709 5000achillestx@consilium-comms.com