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MARSEILLE, France & SEATTLE—HalioDx SAS, an immuno-oncology diagnostic company, and NanoString Technologies Inc., a provider of life-science tools for translational research and molecular diagnostic products, have entered into an agreement to jointly develop and commercialize advanced gene expression assays for assessing the response to immunotherapies.
The immune gene expression signatures under this collaboration were discovered by Dr. Jérôme Galon and his team at the Institut National de la Santé et de la Recherche Médicale (Inserm). Galon has been a long-term advisor of NanoString. HalioDx in-licensed the signature patent portfolio from Inserm and has selected the NanoString platform to translate these signatures into a commercial product for translational research and clinical use. HalioDx and NanoString have been engaged in collaboration discussions since 2015, and entered into a definitive agreement this April.
NanoString and HalioDx will jointly develop assays based on the immune gene expression signatures on the nCounter platform. This could facilitate a wide variety of basic research and translational medicine applications, including biomarker discovery and validation, according to Brad Gray, president and CEO of NanoString.
Vincent Fert, co-founder and CEO of HalioDx, explained that by precisely measuring the immune reaction in and around the tumor, HalioDx tests enable clinicians to determine the degree of severity of a patient’s disease and predict the response to treatment, regardless of the cancer stage or the molecular class. Both companies will jointly offer products and associated services to academic, pharmaceutical and biotechnology customers worldwide.
NanoString and HalioDx are initiating the co-development efforts for the research-use-only (RUO) version of the immune gene expression signatures on the nCounter platform. Both companies will make “commercially reasonable” efforts to make the initial RUO product available for sale in the second half of this year. Additional RUO, investigational-use-only or in-vitro diagnostic products incorporating the immune gene expression signatures may be developed and made available at a later point in time. Potential companion diagnostics (CDx) may be developed and commercialized following execution of a CDx partnering arrangement with a biopharmaceutical company in the future, according to the companies.
“We are excited to jointly develop our innovative predictive and prognostic immune gene expression signatures on the nCounter platform, one of the best multianalyte testing platforms for translating gene expression signatures to routine diagnostic use,” Fert said. “At HalioDx, we want to develop diagnostic solutions that can be easily used in routine clinical practice settings, and we selected the nCounter platform because of its robustness, turnaround time and compatibility with formalin-fixed, paraffin-embedded tissue samples. Our co-developed immune gene expression assays will complement the breakthrough Immunoscore IHC assay to foster the development of more precise immunotherapies.”
The products and services to be developed under this agreement are expected to enable researchers and drug developers to use the assays to assess responses to immunotherapies and select patients most likely to benefit from the therapies. As Fert explained, “We expect that the co-developed immune gene expression assays will be increasingly adopted in translational research and clinical trials to develop clinically validated predictive biomarkers for cancer immunotherapies. The assays have the potential to be developed into CDx for immunotherapies in collaboration with biopharma companies in the future.”
While the companies said that the commercial opportunity for research assays is relatively modest, it could become substantial and closely correlated to the need of predictive biomarkers for immunotherapies, depending on the extent the gene signatures become part of CDx products for use with important new cancer treatments. For a significant cancer indication, hundreds of thousands of patients might be tested each year.
“This collaboration with HalioDx adds another powerful tool to the nCounter immuno-oncology toolkit to support our customers’ efforts in developing clinically validated predictive biomarkers for cancer immunotherapies. With the ability to process small tissue samples with minimal hands-on time, NanoString’s nCounter technology provides a powerful solution to researchers and drug developers who are in search of biomarkers for precision oncology, and is ideally suited to answering complex questions in translational research in the field of immuno-oncology,” Gray concluded.