OncoHost Developing NeutroFlow Test for Guiding Cancer Therapy Selection

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OncoHost Developing NeutroFlow Test for Guiding CancerTherapy Selection

May 30, 2025 | JustinPetrone

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NEW YORK – OncoHost, an Israeli biotechnology company, isworking with three European medical centers to produce a new flow cytometrytest to predict patient response to immunotherapies for five cancerindications, according to Michal Harel, OncoHost's VP of translationalmedicine.

The Binyamina-based company earlier thismonth announced the formation ofthe consortium to develop the test, called NeutroFlow, as well as its backingwith a €2.5 million ($2.8 million) grant awarded through the EU's EuropeanInnovation Council Transition (EIT) program. The project officially commencedon May 1 and will run through April 2028.

Harel described NeutroFlow as a "novel project focusedon the development and validation of a point-of-care diagnostic assay"that will predict a patient's response to immune checkpoint inhibitors (ICIs)across different cancer types. The cancer types targeted include non-small celllung cancer, renal cell carcinoma, melanoma, head and neck squamous cellcarcinoma, and triple-negative breast cancer.

Specifically, Harel said the test would measure theexpression of a subset of neutrophils, called Ly6Ehi neutrophils, that aredistinguished by a high expression of the Ly6E marker on the cell surface. Shereferred to a study published in CancerCell lastyear by researchers at Technion-Israel Institute of Technology andpartners. In the paper, researchers demonstrated that this subset of Ly6Ehineutrophils can serve as an "accurate predictor of response to immunecheckpoint inhibitor therapy across multiple cancer types, outperformingconventional biomarkers," Harel said.

OncoHost's plan is to develop a flow cytometry test formeasuring Ly6Ehi in patients and using those measurements, combined with itsown computational pipeline, to predict how they would respond to differentcancer therapies, ultimately leading to better cancer treatment selection.

"Ly6Ehi neutrophils can be easily detected and measuredusing flow cytometry, an instrument that is available in every hospital,utilized for other clinical tests," Harel pointed out. "TheNeutroFlow test will be designed to provide a simple-to-use, rapid flowcytometry-based test for measuring Ly6Ehigh neutrophils in peripheral bloodsamples," she said.

Current plans are to have a test ready for implementation inhospitals by May 2027, Harel said, and a commercial version of the test will bedeployed by 2028 via OncoHost's US laboratory in Cary, North Carolina, as alaboratory-developed test. Harel said that OncoHost and its partners intend topursue both US and European regulatory clearance for the resulting assay,which, with clinical trials, could take until 2031 to achieve. All businessplans around the test, she added, will be finalized by the end of this year.

"The test is planned to be a point-of-care test runningin the clinic," confirmed Harel. "We aim to obtain a CE-IVDcertificate for that in Europe and Food and Drug Administration approval in theUS."

Each partner in the NeutroFlow consortium will contribute"complementary expertise" to the effort, said Harel. OncoHost is theproject coordinator, and it will manage the endeavor, providing its know-how inproduct development, computation modeling, and business development. TheEuropean Institute of Oncology, based in Milan, will provide access to its flowcytometry facility and will also contribute patient blood samples. IEO willalso conduct on-site flow cytometry analyses and lead related assay developmentand analytical validation of the test, Harel said.

Heidelberg University Hospital in Germany will also provideblood samples and will perform flow cytometry analyses. Virgen MacarenaUniversity Hospital in Seville, Spain, is another partner that will provideblood samples and flow cytometry analyses. The same hospital will also lead theclinical study component of the project, Harel noted, "based on their vastexperience in running large clinical trials." By including partners fromItaly, Germany, and Spain, OncoHost will be able to validate its assay"across diverse European healthcare settings," remarked Harel.

Petros Christopoulos, a professor of medicine at HeidelbergUniversity Hospital, said that as a partner in the project, he is lookingforward to developing NeutroFlow as a cell-based immunotherapy test "foruse in daily clinical practice for further personalization of our cancerpatient care."

OncoHost was established in 2017 to commercialize theresearch of Yuval Shaked, who leads an academic research laboratory atTechnion-Israel Institute of Technology in Haifa. Shaked, whose work hasfocused on understanding tumor-host interactions and the therapy-inducedmechanisms of tumor progression, is a cofounder of OncoHost and serves as itschief scientific adviser.

OncoHost's CEO is Ofer Sharon, a "serialentrepreneur" in Harel's words, who has led the company since 2019. Sharonis also the cofounder and president of Valera Health, a mental healthcareservices provider with offices in Tel Aviv and Brooklyn.

For OncoHost, NeutroFlow is an opportunity to expand itsmenu beyond its flagship ProphetNSCLC test, which the firm offers to supportdecisions concerning first-line immunotherapies for the treatment of non-smallcell lung cancer. That product has been available as a laboratory-developedtest through OncoHost's facility in Cary.

In December, the company announced that its CLIA-certifiedNorth Carolina lab had received accreditation fromthe College of American Pathologists (CAP). Harel said ProphetNSCLC will bemade available in Europe in 2027.

ProphetNSCLC's results are generated through interrogating apatient's blood sample using OncoHost's Prophet platform, which surveys 7,000proteins using a Standard BioTools SomaScan panel. Harel noted thatOncoHost has an agreement withSouth San Francisco, California-based Standard BioTools to use SomaScan as partof its configuration. In addition to running the proteomic assay, the companyhas at its disposal "advanced computational tools for analyzinghigh-dimensional proteomic profiles," said Harel, which enable"deeper insights into biological mechanisms of disease and treatmentresponse."

While the company works on NeutroFlow and continues tocommercialize ProphetNSCLC, it has two other assays in various stages ofdevelopment. One of these is called ProphetRCC, focused on renal cellcarcinoma, and the other is ProphetMelanoma. Harel described both tests asbeing "in advanced stage clinical trials," and said the tests rely onsimilar advanced machine-learning algorithms and proteomic profiling to predictpatient response to ICIs.

The company has another assay in development calledProphetIRAE, which has been designed to support the management of immunotherapysafety through predicting severe immune-related adverse events or immuneresponse adverse events.

"This test adds additional clinical insights to supportdecision-making, enabling oncologists to proactively mitigate risks, improvingpatient outcomes and treatment tolerability," commented Harel. Such a testwill be integrated into OncoHost's menu by helping clinicians make bettertherapy decisions while minimizing associated toxicity.

The anticipated launch date for ProphetRCC will be thefourth quarter of this year, followed by an early 2026 launch forProphetMelanoma. ProphetIRAE will also launch in Q4, Harel said. All will beavailable via the company's lab in North Carolina, with no specific launch datefor Europe planned yet, she added.

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