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HalioDx Aims to Add Breast, Lung Cancer Panels to Dx Menu Amid New Research Collaborations

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NEW YORK (GenomeWeb) – HalioDx is participating in several new research projects that it hopes will result in new products that will benefit its business.

The French immuno-oncology diagnostics firm announced earlier this month that it is taking part in two endeavors funded under France's €74.5 million ($89.3 million) Hospital-University Research in Health (RHU) program.

While HalioDx's involvement in the RHU projects will allow the firm to demonstrate the utility of its various offerings, the three-year-old company also believes that its participation could result in multiple new tests based on its Immunoscore platform, according to CEO Vincent Fert.

"We do have proof-of-concept on several cancers, different cancer types, so now we actually want to broaden the indication into breast cancer as well as lung cancer," said Fert. "With Immunoscore, you look at the immune response, so it's not cancer specific," he said. "Potentially, the content can be applicable to all cancers, because all cancers affect the immune system."

Immunoscore is HalioDx's flagship assay. A version of the test designed for colorectal cancer patients, called Immunoscore Colon, measures the density of two T lymphocyte populations, CD8-positive cytotoxic T cells and CD3-positive T cells. The assay is performed on formalin-fixed, paraffin-embedded tissue from tumor resections or tumor biopsies and combines immunohistochemistry with a high-resolution image analysis system. HalioDx claims the test can be used as a tool for patient management based on their intra- and peri-tumor immune response.

HalioDx announced a CE-IVD mark for Immunoscore Colon in January. In June, it said that its laboratory in Marseille achieved CLIA compliance, enabling it to offer the test to US patients with a 10-day turnaround time. Fert said that HalioDx is assessing its options for further serving the US market through partnering with clinical centers there, opening up its own US CLIA lab, seeking US Food and Drug Administration clearance for the assay, or a combination of the three. While it "revises and reshapes" its strategy for entering the US, HalioDx is looking to develop to develop Immunoscore tests for other indications, and it is here where its newly announced research collaborations play a role.

The first of the new RHU-backed efforts is called Pioneer. It has a budget of €8.5 million and is focused on overcoming resistance to immunotherapy treatment against the PD-1 checkpoint during the treatment of lung cancer. Merck and Bristol-Meyers Squibb have both sold anti-PD-1 checkpoint inhibitors as a first-line treatment in non-small cell lung cancer since 2016.

Fabrice Barlesi, head of multidisciplinary oncology and therapeutic innovations at Assistance publique - Hôpitaux de Marseille (AP-HM),is leading the PIONeer project. He said that while the appearance of these new therapies has no doubt benefitted lung cancer patients, only a fifth to a quarter of them are fully responsive to the drugs, and no alternative therapeutic solutions have been designed or validated for those who don't respond well to the treatment.

In addition to HalioDx, Pioneer also involves other Marseille area researchers, as well as AstraZeneca; Marseille biotech company Innate Pharma; Centre Léon Bérard, a cancer center in Lyon; NovaDiscovery, a Lyon-based company that specializes in in silico biomedical simulations; and Imcheck Therapeutics, a Marseille-based firm developing immuno-modulatory antibodies.

"The aim is to understand and counteract the primary resistances to [immune checkpoint inhibitors] in lung cancer," Barlesi said. "We'll explore a large biomarker panel, along with HalioDx, in responders versus non-responders, with tissue before and after ICI," he said. Following this initial work, the researchers will treat patients progressing within 12 weeks in a randomized early-phase trial conducted at APHM Marseille, Center Léon Bérard, and Toulouse Oncopole using therapies from Innate Pharma and AstraZeneca pipelines, Barlesi noted.

HalioDx's Fert said that the project will not only use Immunoscore to type patients taking part in PIONeeR. The researchers will also use Halioseek, a multiplexed IHC assay the company launched last November that relies on two different dyes to measure the expression of the protein PD-L1 on tumor and immune cells as well as the density of CD8-positive T cells. The assay is optimized for use on FFPE tissue sections and interpreted using the firm's image analysis system.

Fert said that using Halioseek in Pioneer should raise the profile of the offering. "In the end, we will have the ability to demonstrate the competitiveness of our assay," he said.

HalioDx will also employ a third assay in Pioneer called Immunosign, which measures the gene expression levels of several immune genes in a multiplex format on NanoString Technologies' nCounter platform. HalioDx announced an agreement to develop assays on the nCounter platform in April 2016.

Fert said that it is "very possible" that HalioDx's participation in PIONeeR could result in a CE-IVD marked Immunoscore kit for lung cancer, but he did not provide a timeline for when it might become available. The project is slated to run for five years.

MyProbe, the second RHU-backed project that involves HalioDx, has a budget of 9.3 million and aims to develop tools that can identify patients that have a high risk of breast cancer relapse, roughly 10 percent and 15 percent of patients. The work is being done in advance of new therapies that should hit the market by 2019. However, according to a project abstract, about 80 percent of patients won't relapse following conventional therapies, meaning that they will probably not require additional treatment. Fabrice André from Gustave Roussy Cancer Center in Villejuif, a suburb of Paris, who is leading the study, could not be reached for comment.

Other MyProbe participants include researchers at Institut Curie and Center Léon Bérard, as well as Montpellier-based DiaDx, which is developing liquid biopsy cancer tests, and Evry-based IntegraGen, a clinical genomics firm developing tests for autism and cancer. According to a project abstract, each firm will market one of the three molecular classifiers developed.

Fert said that HalioDx has already worked in house on optimizing its IHC Immunoscore assay for detecting early, aggressive breast cancer. "We have always been interested in breast cancer, and would like to expand the indication of Immunoscore into breast cancer," he said. Fert noted that while Immunoscore could hypothetically be used in all cancers, breast cancer is an indication where "patients are very much in need of a prognostic." As MyProbe will survey a cohort of patients who have already had their tissue samples archived, Fert suggested that within three years, it might be possible to validate the use of Immunoscore for breast cancer patients.

"At the end of the project, we could end up with a validated product," said Fert.

PRODIGE and Qiagen

In addition to announcing its participation in Pioneer and MyProbe, HalioDx also recently said that it will work with Partenariat de Recherche en Oncologie Digestive (PRODIGE), a partnership consisting of several French digestive oncology research groups, to further validate the Immunoscore Colon test in stage III colon cancer, focusing on guiding oncologists with their prescription of chemotherapy. As part of the project, Immunoscore Colon will be run on 1,450 patient samples collected during the French International Duration Evaluation of Adjuvant Chemotherapy (IDEA) trial.

Results from IDEA were presented at the American Society of Clinical Oncology annual meeting earlier this year, and showed that for 90 percent of patients with stage III colon cancer, a six-month treatment with the adjuvant chemotherapy agent mFOLFOX6 was superior to a three-month course of the drug. However, they also demonstrated significantly reduced rates of peripheral neuropathy toxicity with the shorter regimen too, and determined that the three-month course is most appropriate for low-risk patients, ultimately recommending a risk-based approach to administering the therapy.

HalioDx will evaluate the 1,450 IDEA samples in its lab, hoping to complete the analysis of the results by the end of 2018.

"We already know that by using Immunoscore in this population, we can tailor [the treatment] very efficiently and adroitly the high-risk population," said Fert, adding that the outcome will be "very important for showing clinical utility," which could help HalioDx with reimbursement in the future.

Separately, Fert addressed HalioDx's relationship with Qiagen. HalioDx was formed in 2014 after Ipsogen's former management team bought the company's assets from Qiagen Marseilles. Ipsogen itself was acquired by Qiagen in 2011.

The German molecular diagnostics firm secured FDA clearance for its Ipsogen JAK2 RGO real-time PCR kit for the diagnosis of the blood cancer polycythemia vera in March. The test, which is performed using Qiagen's Rotor-Gene Q MDx system, is designed to qualitatively detect the JAK2 V617F/G1849T allele in genomic DNA extracted from blood. HalioDx conducted feasibility testing and developed Qiagen's assay, including clinical validation of the test at sites in the US, France, and Italy.

"The [partnership] is going well," said Fert of the work with Qiagen, adding that it provides HalioDx with cash flow as it expands its diagnostics menu. "It's a good model for us."

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