Benzinga | Jan 13, 2022 11:46AM EST

Achilles Therapeutics Provides Business Update And Outlook For 2022

LONDON, Jan. 13, 2022 (GLOBE NEWSWIRE) -- 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(r)) 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(tm) 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