LONDON, Jan. 13, 2022 -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announces a business update and reflects on recent progress with its pioneering, personalized T cell therapy programs targeting clonal neoantigens known as cNeT. As the original mutations formed early in cancer’s development, clonal neoantigens are protein markers that are present on all of an individual’s cancer cells but are absent from healthy tissue. Achilles has developed industry-leading clonal neoantigen discovery technology using real world patient data (TRACERx) and its proprietary bioinformatics platform (PELEUS®) to enable the identification of each patient’s unique clonal neoantigens. With this expertise, Achilles aims to target all of a patient’s tumor cells while sparing healthy tissue, thereby delivering a true precision T cell therapy for the first time using genomic information from a tumor.
Achilles is pleased to report that following regulatory review, the Company plans to use its new, higher-dose manufacturing process, VELOS™ Process 2, for the manufacture of cNeT products in the UK, France, Germany, Spain, and the US. VELOS is a scalable commercial manufacturing process designed to be closed and automated that uses dendritic cells to reduce the need for high dose IL-2, improve T cell fitness, and deliver a product targeting multiple clonal neoantigens. As previously reported at medical congresses in 2021, VELOS Process 2 can increase cell yield to enable delivery of higher doses of cNeT in the Company’s two ongoing clinical trials, CHIRON in non-small cell lung cancer (NSCLC), and THETIS in melanoma.
“The first-in-human, low-dose cohorts in these trials have demonstrated that our platform can detect, quantify and track patient-specific cNeT before and after infusion - a key differentiator of Achilles’ technology that is unique in the field and important for the successful development of TIL-based therapies. The data that we reported throughout 2021 gave a first look at mechanism of action in a TIL product, demonstrated that the Achilles platform can answer potency assay questions, and paved the way to now move to higher cell doses. With this move to our next generation manufacturing process, we have an exciting 2022 ahead of us,” said Dr Iraj Ali, Chief Executive Officer of Achilles.
Outlook for 2022
Achilles has a number of key milestones slated for 2022. These include:
- Acceptance of the US IND for head and neck squamous cell carcinoma (HNSCC) in the first quarter of 2022
- Reporting data in the second half of 2022 from a cohort of patients with higher-dose (Process 2) cNeT as monotherapy in both NSCLC and melanoma
- Reporting data in the second half of 2022 from a cohort of melanoma patients with higher-dose (Process 2) cNeT in combination with a PD-1 inhibitor
- Initiating the Company’s Tumor Archiving Program in the first half of 2022
- Expanding manufacturing capacity in the UK at the Cell & Gene Therapy Catapult
- Establishing a Research & Development facility in the US
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 unresectable locally advanced and metastatic 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.
About the CHIRON and THETIS Clinical Trials
The CHIRON study is an open-label, multi-center Phase I/IIa trial evaluating the safety, tolerability, and clinical activity of cNeT therapy as a single dose in adult patients with advanced metastatic NSCLC. The THETIS study is an open-label, multi-center Phase I/IIa 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.
TRACERx (TRAcking Cancer Evolution through therapy (Rx)), led by Professor Charles Swanton at UCL, is one of the largest deep sequencing, multi-region and multi-time point bioinformatic data sets with over 3,000 tumor samples and represents the single biggest investment in lung cancer research by Cancer Research UK. The TRACERx clinical study aims to transform the understanding of tumor evolution and take a practical step towards an era of precision medicine. The study will uncover mechanisms of cancer evolution by analyzing the intratumor heterogeneity in lung tumors from approximately 850 patients and tracking its evolutionary trajectory from diagnosis through to relapse.
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.
Lee M. Stern, VP, IR & External Communications
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner