Immunoscore®, Immunosign® and Halioseek(TM) at ASCO 2017

• Immunoscore® Colon strong prognostic performance confirmed on N0147 patients' samples and presented in poster sessions
• Results in two trials, including HalioDx immune based assays, presented by biopharma partners at ASCO 2017 
• Meet HalioDx team at booth #15113 to discuss abstracts' content, discover HalioDx products and services and discuss the Just Do IS study for introducing Immunoscore® Colon in clinical centers 

             
Marseille, France, May 23, 2017 - HalioDx SAS, an immuno-oncology diagnostic company, announced its participation at the 2017 American Society of Clinical Oncology Annual Meeting with several posters presented by its collaborators and partners. HalioDx will also be present in booth #15113 to discuss with attendees its diagnostic products and clinical research services.

In the abstract #3579 presented by Sinicrope et al., the prognostic value of individual immune markers and of the standardized Immunoscore® Colon test was evaluated in stage III colon cancer (CC) patients treated with adjuvant FOLFOX. Six hundred (600) resected tumours of stage III CC patients from the FOLFOX arm of the prospective NCCTG N0147 clinical trial were analysed retrospectively for 3 individual immune markers, and for Immunoscore® (IS 0 to IS 4). Immunoscore Low (IS 0-1) was associated with worse DFS^[1] (HR=0.64, CI, 0.45-0.92, p=0.015).

These results provide an additional clinical level of evidence and validate the strong prognostic value of the CE-IVD Immunoscore® Colon assay in a retro-prospective US clinical trial cohort.

The company will also present in its booth the ongoing "Just Do IS" study, conducted with Immunoscore® Colon^[2], the first standardized immune-based assay for the classification of cancer, available as a CE-IVD assay in Europe. Just Do IS is a prospective study aimed at assessing the practicability of the test in the routine management of colon cancer patients. Just Do IS is also creating a community of Immunoscore® experts geared toward its dissemination. Up to now 16 Pathology laboratories and Oncologists teams worldwide confirmed their participation in the study. Additional sign-up are welcome. Results of the study will be available by the end of the year.

In addition, HalioDx will also discuss Halioseek(TM) PD-L1/CD8^[3] assay which will be available as a CE-IVD solution in Q3 2017. Halioseek(TM) PD-L1/CD8, as a member of the Immunoscore® family assays, is a qualitative Immunohistochemistry (IHC)-based assay intended for the detection of PD-L1 protein in Non-Small Cell Lung cancer (NSCLC) tissue (See press release on results presented at AACR 2017). The assay can also be used to evaluate other tumor types.

HalioDx will also present how utilizing its unique range of Clinical Research Services (Immunoscore®, Halioseek(TM), Immunosign®) for assessing the immune microenvironment of tumors and bring robust and unique information to guide immuno-oncology clinical development.

Vincent FERT, CEO of HalioDx comments: "ASCO 2017 is an important milestone for the company as we demonstrate, with data presented by our partners, that our approach to immune oncology diagnostic bring unique information to guide therapeutics development. We are also proud to present the N0147 results, further demonstrating that Immunoscore® Colon has unsurpassed performances for prognostication of stage III colon cancer."

Poster presentation and online publication by our collaborators:

• Association of immune markers and Immunoscore with survival of stage III colon carcinoma (CC) patients (pts) treated with adjuvant FOLFOX: NCCTG N0147 (Alliance)

Abstract #3579

Poster Session: Gastrointestinal (Colorectal cancer)

Poster Board #202

Session Time/Location: Saturday, June 3, 2017: 8:00-11:30 AM CDT, Hall A

Presenter: Frank A. Sinicrope, MD, Mayo Clinic, Rochester, MN

Poster presentations and online publication by our partners:

• Characterization of anti-CD19 chimeric antigen receptor (CAR) T cell-mediated tumor microenvironment immune gene profile in a multicenter trial (ZUMA-1) with axicabtagene ciloleucel (axi-cel, KTE-C19)

Abstract #3025

Poster Session: Developmental Therapeutics - Immunotherapy

Poster Board #120

Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A

Presenter: Jerome Galon, Ph.D., Laboratory of Integrative Cancer Immunology, INSERM

See KITE's press release

• Specific adaptive immune pattern induced by NBTXR3 exposed to radiation therapy in soft tissue sarcoma (STS) patients

Abstract #e14615

See Nanobiotix's press release

About HalioDx
The Immune Response to Cancer Diagnostics

HalioDx is an immuno-oncology diagnostic company providing oncologists with first-in-class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.
HalioDx Immunoscore® technology integrates immunohistochemistry combined with advanced imaging analysis enabling extraction of spatially-organized tissue molecular information.
Immunoscore® is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression.
Pioneered by Jérôme Galon at the Cordeliers Research Center, Paris, France, Immunoscore® Colon is the flagship assay of HalioDx, positioned to be a future diagnostic standard for delivering prognostic and predictive information. HalioDx develops also assays such as Halioseek(TM) and Immunosign® to help stratifying patients for immunotherapies.
HalioDx collaborates with an increasing number of renowned international clinical groups and biopharmaceutical companies to support clinical utility and ensure rigorous performance validation of its assays in a large number of cancer indications.
HalioDx has an experienced team of more than 100 employees, a CLIA-certified laboratory (H1 2017) and compliant facilities to develop, manufacture, register and market in vitro diagnostic (IVD) products.
HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies.
The company co-founded the European immunology cluster Marseille Immunopole (MI).

For more information, please visit our website www.haliodx.com and follow the company on Twitter @HalioDx.

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