Achilles Therapeutics Presents Positive Data at ESMO I-O Congress 2021 on High-Dose Manufacturing Process for Precision T Cell Therapies Targeting Clonal Neoantigens

Rhea-AI Summary

Achilles Therapeutics (NASDAQ: ACHL) reported significant advancements at the ESMO Immuno-Oncology Congress 2021, showcasing a over 10-fold increase in clonal neoantigen-reactive T cell (cNeT) doses with their VELOS™ Process 2 manufacturing. This process has successfully transitioned to GMP-scale for clinical trials, maintaining critical T cell subsets. The company aims to commence high-dose patient dosing in the first half of 2022, with results from clinical trials expected by the second half of the same year.

Positive

• VELOS Process 2 manufacturing achieves >10-fold increase in cNeT doses over Process 1.
• GMP validation for clinical use has been completed, supporting ongoing Phase I/IIa trials.
• Process 2 maintains both CD4+ and CD8+ T cell subsets with a potent polyclonal phenotype.

Negative

• None.

-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.

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 significant advancement did Achilles Therapeutics announce regarding cNeT doses?

Achilles Therapeutics announced a greater than 10-fold increase in clonal neoantigen-reactive T cell (cNeT) doses with their VELOS™ Process 2 manufacturing.

When is Achilles Therapeutics expected to begin dosing patients with high-dose cNeT?

Achilles Therapeutics expects to begin dosing patients with high-dose cNeT in the first half of 2022.

What is the significance of the VELOS Process 2 for Achilles Therapeutics?

VELOS Process 2 significantly boosts cNeT doses and has been validated for clinical use, enhancing the efficacy of T cell therapies for solid tumors.

What trials are currently ongoing for Achilles Therapeutics?

Achilles Therapeutics has two ongoing Phase I/IIa trials: the CHIRON trial for non-small cell lung cancer and the THETIS trial for melanoma.

When can we expect clinical data from Achilles Therapeutics' trials?

Clinical and translational science data from the trials are expected to be available in the second half of 2022.