HalioDx raises $23M to expand I-O test suite, enter U.S.

People working at HalioDx's laboratory. (Image: HalioDx)

HalioDx has raised $22.7 million to expand use of its immuno-oncology diagnostics. The expansion will entail validating the use of the tumor microenvironment tests in new indications while setting up a lab in the U.S. to drive growth internationally.

Marseille, France-based HalioDx’s near-term focus is on the development of Immunoscore as a way to assess the risk of relapse in colon cancer patients. The process involves taking samples from the core and invasive margin of a tumor. HalioDx then uses its immunohistochemistry assay to show the concentrations of CD3 and CD8 T cells in each region. 

“We use advanced digital pathology to count lymphocytes in these two regions and derive a score that has a strong prognostic performance,” HalioDx CEO Vincent Fert said. 

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The focus on the concentration of lymphocytes in different parts of the tumor reflects the influence of Jérôme Galon, Ph.D. Galon is behind the immune-contexture concept, which uses the density, composition, functional state and organization of tumor leukocyte infiltrate to predict how a patient will progress and respond to treatment. 

Galon and Fert cofounded HalioDx in 2014 when the latter person and some colleagues spun assets out of Qiagen. The spin-out came four years after Qiagen bought the last company Fert founded, Ipsogen. Fert was joined at HalioDx by colleagues from his time at Ipsogen and Qiagen. 

Since then, HalioDx has advanced standalone Immunoscore diagnostics while also using its assays to help biopharma companies understand their immuno-oncology drugs. These assays could become companion diagnostics. 

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MI Care, Sham Innovation Santé/Turenne, BNP Paribas Development and Sofipaca bankrolled the first phase of this strategy work by putting together a $10 million series A round in 2015. Those investors returned for the series B and were joined by a clutch of new backers, including funds managed by Bpifrance, Capricorn Venture Partners and Amundi.

The dialing up of the money available to HalioDx equips it to expand in two directions. Some of the cash will go toward broadening the list of cancers served by Immunoscore tests. Rectal, bladder and breast cancer are on HalioDx’s hit list. 

HalioDx will use another slice of the funding to expand in the U.S.

“We plan to set up a CLIA lab in the U.S. and develop market access and reimbursement for colon cancer,” Fert said.

Fert sees the market access and reimbursement side of the strategy being boosted in 2018 by data from the clinical program HalioDx has run to support Immunoscore. The clinical plan is designed to deliver data to convince oncologists and payers of the value of the test.