Teiko, a CLIA clinical laboratory for monitoring the immune response, announced the publication of a review paper in Bioanalysis: https://doi.org/10.1080/17576180.2026.2744519. The paper, “Application of sample stabilization and mass cytometry in global oncology trials: lessons from regulatory T cell monitoring,” draws on the companies’ work in the first-in-human study of roginolisib, clinical precision oncology company iOnctura’s conformation-selective PI3K-delta inhibitor that locks the enzyme in its inactive state, and describes Teiko’s mass cytometry work in three ongoing roginolisib trials.
Sponsors for global trials face a common challenge: developers rely on rare immune cell populations, such as regulatory T cells (Tregs), as pharmacodynamic biomarkers, which must be measured consistently across sites and over time. Two barriers limit this measurement in global oncology trials: specimen degradation and slow panel development.
Blood specimen degradation initiates immediately after venipuncture, and live specimens exceeding a 72-hour transit window must be excluded from analysis, which historically impacted samples for subsequent studies by standard flow cytometry. The problem is compounded in trials with global sites, where specimens cross multiple borders and customs and face longer transit.
The second problem is that measuring rare cell populations, such as Tregs, requires intracellular markers, which employs panel customization, which can take months. Such panels further reduce the available cells for subsequent immune monitoring techniques.
In this review paper, iOnctura and Teiko describe:
- Specimen fixation to overcome specimen loss, especially for small immune cell subsets. Fixing blood at the clinical site with a fixation kit (TokuKit) stops the time-dependent cell loss and removes the 72-hour live-cell shipping window.
- Mass cytometry to overcome panel design challenges. A more than 20 marker-consisting mass cytometry assay can be qualified in approximately three weeks, against approximately six months for the equivalent spectral flow cytometry assay.
“Stabilizing blood at the clinical site and analyzing it in one central laboratory removes much of the noise that comes with multinational trials. Sponsors running trials across country borders face the same problem of immune cell monitoring and we are pleased to be utilizing this solution provided by Teiko. This approach optimizes our understanding of how roginolisib acts on the cancer of patients participating in our trials,” said Michael Lahn, MD, Chief Medical Officer of iOnctura.
About Teiko
We are building a laboratory to digitize the immune system and reshape multi-billion dollar markets across clinical trials, oncology, autoimmune diagnostics, prenatal medicine, surgical recovery, and aging. By capturing high-resolution immune snapshots, we give drug developers and doctors the decisive signal needed to monitor whether a $200M+ clinical trial succeeds, whether a therapy will cause irreversible harm, or whether a patient will respond to a crucial drug.
About iOnctura
iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is the first conformation-selective inhibitor targeting the inactive form of PI3Kδ. This novel binding mode allows for precise inhibition of PI3Kδ, delivering clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura is headquartered in Amsterdam, The Netherlands with subsidiaries located in Geneva, Switzerland and Cambridge, MA, USA. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture.
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