Over 10-fold dose increase at GMP scale with VELOS™ Process 2 manufacturing
cNeT maintain CD4+ and CD8+ T cell subsets with a highly potent polyclonal phenotype
Dosing of patients with high-dose cNeT expected in 1H 2022
LONDON, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today presented positive data at the ESMO Immuno-Oncology Congress 2021 (ESMO I-O) that further demonstrate that Achilles’ VELOS™ Process 2 manufacturing increases clonal neoantigen-reactive T cell (cNeT) doses by more than 10-fold over Process 1 at GMP scale and maintains a highly potent polyclonal phenotype. These data add to the pilot scale proof-of-concept study recently reported at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
“We are extremely pleased to have demonstrated the ability to generate a significant boost in cNeT dose over Process 1 in clinical-scale runs and to have successfully completed the technology transfer of Process 2 into clinical manufacture,” said Dr Ed Samuel, SVP Technical Operations of Achilles. “These Process 2 GMP data validate our previously reported R&D data and confirm retention of critical phenotypic characteristics and the ability to identify the active drug component of our products without adding to end-to-end manufacturing time. We anticipate dosing patients with high-dose Process 2 cNeT in the first half of 2022, with 6-week clinical and translational science data available in the second half 2022.”
Key highlights from the presentation entitled “Achilles VELOS Process 2 generates a >10-fold improvement in cNeT dose over Process 1 with a highly potent polyclonal phenotype and has been successfully validated at GMP scale for clinical use in solid cancer,” include:
- Reporting that GMP validation of VELOS Process 2 has successfully been completed and transferred into clinical manufacture in Achilles’ ongoing Phase I/IIa CHIRON and THETIS clinical trials
- Showing that VELOS Process 2 generates a cell product that retains both CD4+ and CD8+ T cell subsets and maintains polyclonal cNeT reactivity with a favorable cell fitness phenotype
- Demonstrating the quantification of the active cNeT drug component with Achilles’ proprietary potency assay which further underlines the strength of the Achilles platform
Achilles ESMO I-O 2021 Poster Details
Title: Achilles VELOS Process 2 generates a >10-fold improvement in cNeT dose over Process 1 with a highly potent polyclonal phenotype and has been successfully validated at GMP scale for clinical use in solid cancer
Authors: Evi Rologi, et al.
Date & Time: Poster available online from Thursday, December 9, 2021, at 12:30 PM CET / 11:30 AM UK / 6:30AM ET
Poster ID: 58P
The poster presentation is available in the Events & Presentations section of the Company website.
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.
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