Achilles Therapeutics Doses First Patient with Higher-dose cNeT in Phase I/IIa CHIRON Trial in Advanced NSCLC and Initiates Enrollment in Cohort B of the THETIS Trial (cNeT + PD-1 checkpoint inhibitor) in Metastatic Malignant Melanoma

Rhea-AI Summary

Achilles Therapeutics (NASDAQ: ACHL) has announced significant progress in its clinical trials. The first patient received a personalized clonal neoantigen-reactive T cell (cNeT) in the CHIRON trial for advanced non-small cell lung cancer (NSCLC). Following a positive review by the Independent Data Safety Monitoring Committee, enrollment for THETIS Cohort B has also begun, testing cNeT with a PD-1 inhibitor for metastatic melanoma. Results from both trials are anticipated in the second half of 2022, highlighting the company's commitment to treating difficult cancers.

Positive

• First patient dosed in CHIRON trial with cNeT therapy for advanced NSCLC.
• Enrollment initiated in THETIS Cohort B, evaluated cNeT with PD-1 inhibitor.
• Positive review from Independent Data Safety Monitoring Committee.
• Higher-dose VELOS Process 2 expected to enhance cNeT efficacy.

Negative

• Current prognosis for advanced NSCLC patients is poor, with only a 35% five-year survival rate.

- THETIS Cohort B enrollment follows positive Independent Data Safety Monitoring Committee review -

- Monotherapy data from higher-dose cohorts in both CHIRON and THETIS and combination data from THETIS Cohort B expected in 2H 2022 -

LONDON, May 09, 2022 (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 has been dosed with personalized clonal neoantigen-reactive T cells, or cNeT, manufactured with the Company’s higher-dose VELOS™ Process 2 in the ongoing Phase I/IIa CHIRON clinical trial for the treatment of advanced non-small cell lung cancer (NSCLC). Additionally, following a positive review by an Independent Data Safety Monitoring Committee, the Company has initiated enrollment in Cohort B of the THETIS clinical trial to evaluate cNeT in combination with a PD-1 checkpoint inhibitor for the treatment of metastatic malignant melanoma.

“Dosing the first patient in CHIRON with cNeT from our higher-dose manufacturing process and initiating enrollment in THETIS Cohort B, which will evaluate cNeT in combination with a PD-1 inhibitor, are major milestones for Achilles. Our personalized cell therapy has been developed to address the hardest to treat cancers, including NSCLC and melanoma, which often become resistant to other treatments,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “Our VELOS Process 2 has been shown to deliver increased cNeT doses while retaining T cell fitness. We are excited by the therapeutic potential of our higher-dose cNeT monotherapy and cNeT combination treatments and look forward to reporting clinical data in the second half of 2022.”

VELOS is a scalable commercial manufacturing process designed to be closed and automated. The proprietary process uses dendritic cells to deliver a personalized, precision T cell-based therapy that selectively targets multiple clonal neoantigens with improved T cell fitness and reduced need for high-dose IL-2. As original mutations formed early in cancer development, clonal neoantigens are protein markers present on all cancer cells but absent from healthy tissue, making them ideal cancer targets.

“Over 2 million patients are diagnosed with lung cancer annually worldwide, with NSCLC accounting for 82% of all diagnoses. The current prognosis is poor with a 35% five-year survival rate for patients with advanced NSCLC, dropping to 7% for those with metastatic NSCLC,” added Dr Karl Peggs, Chief Medical Officer of Achilles Therapeutics. “Melanoma is the fifth most common cancer among men and women, with a survival rate of 30% when it has spread to other, distant parts of the body. Since both are common indications with poor prognosis at advanced stages, we look forward to evaluating how our higher-dose cNeT therapy and combination with a PD-1 inhibitor may help improve treatment responses and change the paradigm for these patients.”

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 AI-Powered 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.

About the CHIRON and THETIS Clinical Trials
CHIRON is an open-label, multi-center Phase I/IIa clinical trial evaluating the safety, tolerability, and clinical activity of cNeT therapy as a single dose in adult patients with advanced metastatic NSCLC. THETIS is an open-label, multi-center Phase I/IIa clinical trial evaluating the safety, tolerability, and clinical efficacy of cNeT therapy as a single dose in patients with recurrent or metastatic malignant melanoma as monotherapy and in combination with a PD-1 inhibitor. 

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.

Investors:
Achilles Therapeutics
Lee M. Stern, VP, IR & External Communications
l.stern@achillestx.com

LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com

Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
achillestx@consilium-comms.com

FAQ

What are the latest developments for ACHL in clinical trials?

Achilles Therapeutics has dosed the first patient in the CHIRON trial for NSCLC and initiated THETIS Cohort B enrolling patients for melanoma.

What is the significance of the THETIS Cohort B enrollment for ACHL?

The THETIS Cohort B trial will evaluate cNeT therapy in combination with a PD-1 inhibitor to potentially improve treatment responses for melanoma patients.

When can we expect results from ACHL's clinical trials?

Results from the CHIRON and THETIS trials are expected in the second half of 2022.

What does the VELOS Process 2 mean for ACHL's therapies?

The VELOS Process 2 allows for the manufacturing of higher-dose cNeT therapies, which could enhance treatment efficacy and T cell fitness.

What challenges does ACHL face with its current therapies?

Achilles Therapeutics faces significant challenges, as current survival rates for advanced NSCLC and metastatic melanoma are low.