Achilles Therapeutics Enrolls First US Patient in Ongoing Phase I/IIa Study in Advanced Non-small Cell Lung Cancer

Rhea-AI Summary

Achilles Therapeutics plc (NASDAQ: ACHL) announced the enrollment of the first US patient in its CHIRON clinical trial for treating advanced non-small cell lung cancer (NSCLC) with precision T cell therapy. The trial, which has opened at 10 sites across the UK, EU, and US, aims to enroll up to 40 patients to assess the safety and efficacy of its clonal neoantigen T cell (cNeT) therapy. The CEO expressed optimism about the potential of their innovative approach targeting patient-specific neoantigens. Updates from 10 patients are expected in Q4 2021.

Positive

• First patient enrolled in the US CHIRON trial, indicating progress and milestone achievement.
• CHIRON trial aims to evaluate safety and tolerability of precision cNeT therapy, addressing a significant unmet need in NSCLC.

Negative

• Trial enrollment targets only 40 patients, limiting data scope for broader conclusions.
• The reliance on clinical trial outcomes involves inherent risks and uncertainties.

- 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.”

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 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 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

FAQ

What is the ACHL CHIRON trial?

The CHIRON trial is a Phase I/IIa clinical trial evaluating clonal neoantigen T cell (cNeT) therapy in patients with advanced non-small cell lung cancer (NSCLC).

When was the first patient enrolled in the US CHIRON trial?

The first US patient was enrolled on July 1, 2021, at Moffitt Cancer Center in Tampa, FL.

What are the primary objectives of the ACHL CHIRON trial?

The primary objectives are to assess the safety and tolerability of cNeT therapy, with clinical efficacy being evaluated as a secondary measure.

How many patients is the ACHL CHIRON trial planning to enroll?

The CHIRON trial aims to enroll up to 40 patients with advanced unresectable or metastatic NSCLC.

What is the significance of the CHIRON trial for ACHL investors?

The CHIRON trial's progress and results could significantly impact ACHL's stock performance by demonstrating the efficacy and safety of its innovative cNeT therapy.