NEW YORK – Novigenix, a Swiss immuno-transcriptomics company, has another liquid biopsy test in its pipeline, this time one that could be used to guide therapy selection in aggressive prostate cancer cases.
The firm last week announced it received a Eurostars grant that will allow it to have a prototype of the test, called Myelo-Scan, ready by the end of 2026. Novigenix is working with several partners to develop the test, and said it is aiming to obtain a European CE-IVD mark "shortly thereafter."
Novigenix is a privately held company, headquartered in Épalinges, a suburb of the Swiss city of Lausanne. It currently has 18 full-time employees and since the firm's 2014 founding, it's been focused on developing a menu of RNA-based liquid biopsy tests that use artificial intelligence to analyze immune-related gene expression for early evidence of disease or response to different therapies.
With its new €1.75 million ($1.95 million) Eurostars grant, it will develop over the next two years a next-generation sequencing-based liquid biopsy test for predicting intratumoral myeloid-derived suppressor cell (MDSC) infiltration in metastatic, castration-resistant prostate cancer (mCRPC) patients.
MDSCs are defined by their ability to suppress T-cell responses and mCRPC is cancer that continues to grow even when testosterone levels are at or below the castrate level. Eurostars is a European funding instrument that supports small- and medium-sized enterprises and their partners, such as universities or research organizations.
According to Pedro Romero, chief medical and scientific officer at Novigenix, there exists on the market a "critical unmet need" for such a test.
"Prostate cancer remains a significant challenge, particularly for patients who develop mCRPC," Romero said. "These patients often become resistant to standard therapies, and there are few tools available to predict which patients will respond to treatment."
Other companies are also seeking to address this need. Hedera Dx, based right down the street in Épalinges, recently expressed interest in applying its next-generation sequencing-based, liquid biopsy testing platform in prostate cancer. Across the Atlantic, Indianapolis-based Early is Good (EIG) in April announced an agreement with the Mayo Clinic to develop a liquid biopsy test for advanced prostate cancer.
Some diagnostic testing firms have crafted agreements with drugmakers to develop such tests for guiding prostate cancer treatment. Angle, a UK company, has such an agreement to develop a liquid biopsy test for AstraZeneca. Meanwhile, in June, the US Food and Drug Administration approved the use of Foundation Medicine's FoundationOne Liquid CDx to identify advanced BRCA-mutated prostate cancer patients who are eligible for treatment with Janssen's therapy Akeega (niraparib and abiraterone acetate).
According to Romero, what sets Novigenix's effort apart is its focus on MDSC activity, which he deemed a "unique approach" to address treatment resistance in patients with mCRPC. This could make Myelo-Scan the first liquid biopsy test to achieve the identification of this mCRPC subpopulation of patients, he said.
My-Signature and Myelo-Scan
The new Eurostars funding will support test development through My-Signature, a consortium involving Novigenix and partners at Radboud University and Crown Bioscience. Romero said the company has a "history of productive partnership" with Radboud University Medical Center (RUMC) in Nijmegen, Netherlands, and specifically with Niven Mehra, an associate professor of medical oncology, and Sandra van Wilpe, a researcher at RUMC.
Mehra said in an email that he has been interested in studying MDSCs for about a decade, but that the technology has not existed to interrogate them. "The problem has always been the cumbersome detection of these cells, by flow cytometry or immunohistochemistry," he said.
With Novigenix, he said he aims to develop a signature that could be used to identify patients where additional anti-MDSC therapies, such as androgen deprivation therapy, might be beneficial. This could be combined with standard therapies, he said, as it's known that MDSCs drive treatment resistance for anti-hormonal therapies, and immuno- and chemotherapy, as well as other therapies, such as PARP inhibitors and prostate-specific membrane antigen-directed radioligand therapy, or PSMA-RLT.
Novigenix and RUMC also partnered on a separate Eurostars-funded project called PRECISE in 2021 and have since developed an RNA marker set for predicting the clinical benefit to patients with metastatic bladder cancer who were treated with immunotherapy during a second line of treatment. PamGene, a Dutch technology firm, also took part in the PRECISE project.
Using its machine-learning tool set, Novigenix was also able to craft a predictive multimodal model that combines an immuno-transcriptomic predictive biomarker with circulating-tumor DNA data provided by the team at RUMC. Novigenix and its partners presented data around the resulting test, called LBx 360, at the European Society for Medical Oncology conference held in Barcelona, Spain, earlier this month.
For the new My-Signature study, Novigenix has partnered with the Dutch office of Crown Bioscience, a San Diego-headquartered global contract research organization. This will allow access to Crown Bioscience's ex vivo patient platform in the Netherlands, Romero noted.
"This platform enables us to obtain tumor-infiltrating MDSC signatures at the single-cell transcriptomic-level from fresh biopsies," said Romero. These biopsies will be selected and provided by the team at RUMC, with its deep-seated expertise in genito-urinary cancers and immunology, he said.
The RUMC team will also contribute to the quantification of MDSC infiltration in archived patient tumors using their fully automated multiplex immunohistochemistry assay, he added.
Should the study be successful, Novigenix aims to be able to stratify patients more effectively and help to personalize their treatments with the resulting Myelo-Scan test. Romero described Myelo-Scan as consisting of gene expression data obtained from about 2-5 mL of peripheral whole blood, coupled with an internally developed predictive algorithm. This algorithm ideally should stratify mCRPC patients who are more likely to benefit from the standard of care with a lower likelihood of resistance into an MDSC-low group, and those more likely to benefit from a combination of therapies, including standard-of-care and MDSC-targeting therapies, into an MDSC-high group.
This should ultimately help to improve mCRPC patient outcomes.
The data for Myelo-Scan will be generated using next-generation sequencing for biomarker discovery and validation, Romero noted. The final biomarker panel will likely be moved to another technology platform to "optimize turnaround time," and it will be made available as a service.
Romero said the company believes its test could be ready for clinical validation by the fourth quarter of 2026. A CE-IVD marking should follow, he said.
While that might seem like a short route to market, Romero said that Novigenix and its partners are confident in its timeline, which he said was "rooted in the strong preliminary work" the partners did during the PRECISE project. He noted that evidence exists that inhibition of myeloid chemotaxis can reduce tumor-elicited myeloid inflammation, and reverse therapy resistance in patients with metastatic, castrate-resistant prostate cancer. This much was shown in a November 2023 Nature paper published by another international team.
Novigenix has a number of tests on the market or in its pipeline. In addition to the aforementioned LBx 360 bladder cancer test it developed during the PRECISE project, it also offers Liquid Immuno-transcriptomics (LITO)Seek, an artificial intelligence-driven liquid biopsy platform that offers pharmaceutical firms access to transcriptomic information that they can use to gauge the immune system's response to potential cancer treatments. The company launched the test earlier this year.
Another is Colox, a 29-marker blood test offered since 2015 in Switzerland for detecting early-stage colorectal cancer for patients aged 45 and up. According to the firm, Colox detects colorectal cancer in such patients with an accuracy of 78 percent, as well as adenomatous polyps with an accuracy of 52 percent. It markets the Colox test in partnership with Unilabs as a laboratory-developed test service, but is developing a next-generation version of the test, called Colox NGS 360, for mass market adoption, Romero said.
"This liquid biopsy assay uses RNA-stabilized whole blood in combination with cell-free DNA for a colorectal cancer screening assay with best-in-class detection of advanced adenomas," he said.
Romero said that Novigenix sees Myelo-Scan as bulking up its menu of liquid biopsy immuno-transcriptomic tests, such as Colox and LBx 360.
"Myelo-Scan would add a patient stratification test in the specific mCRPC indication," he said.