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HalioDx launches Halioseek™ CR (PD-L1/CD8), a new assay toward precision immunotherapy

• Analyzing both adaptive immunity (CD8+ T cells) and PD-L1 expression status should allow clinicians to improve Immune Checkpoint Inhibitors (ICI) prescription & patients’ stratification.

• Halioseek™ CR is already available as a Clinical Research (CR) service for biopharmaceutical companies and academic centers evaluating PD1/PD-L1 pathway blockade.

  • Analyzing both adaptive immunity (CD8+ T cells) and PD-L1 expression status should allow clinicians to improve Immune Checkpoint Inhibitors (ICI) prescription & patients’ stratification.
  • Halioseek™ CR is already available as a Clinical Research (CR) service for biopharmaceutical companies and academic centers evaluating PD1/PD-L1 pathway blockade.

HalioDx SAS, an independent immuno-oncology diagnostic company, today announced that its assay Halioseek™ CR (PD-L1/CD8) - previously designated as Immunoseek CR - is available as a clinical research service for biopharmaceutical companies and academic centers. Halioseek™ CR has been optimized for Non-Small Cell Lung Cancer (NSCLC). The assay can be used to evaluate other tumor types.

PD1/PD-L1 pathway blockade has elicited durable clinical responses in a fraction of cancer patients but clinicians are still waiting for a robust predictive biomarker of response. Today, we know that PD-L1 expression is more an indicator of the likelihood of response than a predictor of response, this is why the solution must include the other key parameter of the game: the intra-tumor immune response. Today, HalioDx provides clinicians and biopharmaceutical developers the very first standardized assay that will allow them to analyze these two biomarkers simultaneously.

The Halioseek™ CR (PD-L1/CD8) assay measures both the expression of PD-L1 on tumor and immune cells and the density CD8+ (cytotoxic) T cells in a multiplexed IHC assay on a unique slide using two different dyes (colors). It is a standardized full service solution, optimized for utilizing minimal amount of FFPE tissue, where interpretation is combining high-resolution image analysis system with a proprietary bioinformatics pipeline.

The assay can provide tumor microenvironments classification in 4 types, type I (adaptive immune resistance), type II (immunological ignorance), type III (intrinsic induction), and type IV (tolerance), based on the presence of TILs and PD-L1 expression (Teng et al.  Cancer Res. 2015), to guide Immunotherapeutic strategies. In addition, thanks to advanced image analysis, distances between these cell populations can be utilized together with clinico-pathologic parameters to improve further microenvironment‘s classification. A significant correlation between the proximity of the PD1 and PD-L1(+) cells and pre-existing CD8(+) T cells at the invasive tumor margin with the response to ICI treatment has been demonstrated in melanoma (Tumeh et al. Nature 2014 ; Taube JM, Sc Trans Med. 2012; Sznol M, Clin Cancer Res. 2013; Teng et al. Cancer Res. 2015).

HalioDx is about to launch an independent study to establish the concordance between Halioseek™ and the existing PD-L1 tests currently under investigation in NSCLC. A CE marked Halioseek™ test is under development.

Vincent FERT, CEO of HalioDx comments:because it measures the two strongest components of the immune microenvironment with respect to the known ICI mechanism of action, Halioseek™ CR (PD-L1/CD8) has the potential to become the reference assay for precision Immunotherapy”. He adds: “A decentralized version of the assay is under development to provide our pharmaceutical partners a unique solution for PD-1/PD-L1 ICI development and registration.

 

HalioDx at SITC congress, Nov. 9 -13, 2016, National Harbor, Maryland, USA

New performance data for Immunoscore® Colon will be presented in the following oral presentations:

  •          Immunoscore® Colon Analytical Performance presented by Dr Fabienne Hermitte, VP, R&D – Reg & Medical Affairs – HalioDx | Concurrent Session II: Promoting and Measuring Antitumor Immunity

Friday, November 11th, 5:50 – 6:05 p.m, Maryland A.

A poster will also be presented the same day (Poster# 341)

  •          Immunoscore as a Prognostic Marker in Stage I-III Colon Cancer: Results of a SITC-Led Global Validation Study presented by Dr Jérôme Galon – Cordeliers Research Center – Paris, FranceUpdate Session: Society Initiatives

Saturday, November 12th, 7:40 – 7:55 a.m, Maryland Ballroom

  •          Combination in Patient Selection presented by Dr Jérôme Galon – Cordeliers Research Center – Paris, France | Beyond Single-Agents: The Future of Combination Immunotherapy

Saturday, November 12th, 9:35 – 10:00 a.m, Maryland Ballroom

 

HalioDx Booth #212

Don’t miss the opportunity to meet and discuss with HalioDx’s team at SITC congress.