Teiko Publishes Bioanalysis Review Highlighting Sample Stabilization and Mass Cytometry for Immune Monitoring in Global Oncology Trials
Teiko, a CLIA-certified clinical laboratory specializing in immune response monitoring, has announced the publication of a review paper in the scientific journal Bioanalysis. The paper, titled “Application of sample stabilization and mass cytometry in global oncology trials: lessons from regulatory T cell monitoring,” examines practical approaches to improving immune-cell analysis in multinational oncology clinical trials. It draws on the companies’ experience supporting the first-in-human clinical study of roginolisib, an investigational conformation-selective phosphoinositide 3-kinase delta (PI3K-delta) inhibitor developed by clinical precision oncology company iOnctura.
The publication discusses Teiko’s mass cytometry work across three ongoing clinical trials evaluating roginolisib. It focuses on two persistent challenges in global clinical research: maintaining the integrity of blood specimens during international transportation and developing analytical panels capable of reliably identifying rare immune-cell populations. The review describes how combining sample stabilization at clinical sites with mass cytometry analysis at a central laboratory can help address these challenges and support more consistent pharmacodynamic biomarker monitoring.
The paper is available online through Bioanalysis at: https://doi.org/10.1080/17576180.2026.2744519.
Improving Immune Monitoring Across Global Oncology Trials
Immune monitoring has become an important component of oncology drug development. As researchers investigate how experimental therapies influence the immune system, they increasingly rely on specific immune-cell populations as pharmacodynamic biomarkers. These biomarkers can help demonstrate whether a treatment is producing its intended biological effects and provide insights into the mechanisms through which a candidate drug interacts with the disease.
Regulatory T cells, commonly known as Tregs, are one such population. Tregs play a central role in regulating immune activity and maintaining immune-system balance. In cancer, however, these cells can contribute to an immunosuppressive tumor environment, potentially limiting the body’s ability to mount an effective antitumor response. Monitoring changes in Treg populations can therefore provide valuable information about the biological activity of investigational cancer treatments.
For clinical-trial sponsors, measuring these cells accurately and consistently is essential. Results must be comparable across different clinical sites, geographic regions and time points. This requirement becomes particularly important in multinational studies, where blood samples may be collected in countries with different logistical conditions and then transported to a central laboratory for analysis.
However, global oncology trials face practical obstacles that can compromise immune-cell measurements. Two of the most significant challenges are the deterioration of blood specimens during transportation and the time required to develop specialized analytical panels for detecting rare cell populations.
The review by Teiko and iOnctura examines how sample stabilization and mass cytometry can help overcome these limitations. By addressing specimen handling and analytical development together, the companies aim to improve the reliability and efficiency of immune monitoring in complex clinical research programs.
Blood Specimen Degradation Creates Challenges for International Studies
Blood samples begin to undergo biological changes immediately after collection. Once blood is removed from the body, cells can progressively lose their original characteristics as they are exposed to changes in temperature, transportation conditions and elapsed time. These changes may affect the ability of laboratories to identify and quantify specific immune-cell populations accurately.
This issue is especially important when studies depend on rare cell subsets, including Tregs. Because these populations may represent only a small proportion of the total cells in a blood specimen, even relatively modest cell loss can affect the quality and reliability of the resulting measurements.
Traditional immune-monitoring approaches frequently depend on the transportation of live blood specimens to a central testing laboratory. Under the approach described in the review, live specimens that exceed a 72-hour transit window must be excluded from analysis. This limitation can result in the loss of valuable clinical samples, particularly when trial sites are located far from the laboratory performing the testing.
The challenge becomes more complicated in multinational clinical trials. Specimens collected at international sites may need to travel across several countries, pass through customs procedures and undergo multiple stages of transportation before reaching their destination. Delays caused by international shipping, border controls and logistical arrangements can make it difficult to maintain the required transit conditions.
As a result, samples may arrive too late for reliable analysis, reducing the amount of usable biomarker data available to investigators. Missing or compromised samples can also make it more difficult to compare immune responses among patients enrolled at different locations.
For sponsors, these issues can affect trial efficiency and complicate the interpretation of pharmacodynamic findings. When sample loss occurs disproportionately at particular sites or regions, it may also introduce variability into the overall dataset.
The review identifies sample stabilization at the clinical site as a way to reduce the dependence on rapid transportation of live specimens. Rather than shipping untreated blood under a strict time limit, clinical teams can use a fixation process to preserve the cells for subsequent laboratory analysis.
Clinical-Site Fixation Helps Preserve Rare Immune-Cell Populations
One of the approaches described in the publication involves fixing blood samples at the clinical site using Teiko’s TokuKit fixation kit. The process stabilizes the specimen soon after collection, stopping the time-dependent loss of cells that can occur when live blood is transported over extended periods.
By stabilizing the sample before shipment, the approach removes the need to maintain the same 72-hour live-cell transportation window. This can be particularly beneficial for clinical studies involving geographically dispersed sites, where international shipping and customs procedures may otherwise create substantial delays.
The method is designed to help preserve the immune-cell populations required for downstream testing, including small and less abundant subsets that may be difficult to measure reliably after prolonged transportation.
Clinical-site fixation can also simplify sample logistics. Instead of requiring every site to coordinate rapid shipment of fresh specimens, the trial can use a standardized stabilization procedure before samples are sent to a central laboratory. This provides an opportunity to reduce variability associated with differences in transit time and transportation conditions.
Centralized analysis remains important because it allows samples from multiple countries to be evaluated using consistent laboratory procedures. When specimen stabilization is performed at the collection site and testing is conducted at one central facility, sponsors can reduce some of the logistical and analytical differences that may otherwise affect comparisons between trial locations.
For global oncology programs, this combination can support more dependable biomarker datasets and help investigators obtain a clearer understanding of treatment-related changes in immune-cell populations.
Mass Cytometry Addresses Challenges in Panel Development
The second major issue discussed in the review concerns the development of analytical panels for monitoring rare immune-cell populations.
Identifying Tregs and other specialized immune subsets requires more than simply measuring the total number of immune cells in a blood specimen. Researchers must distinguish specific cell populations based on combinations of biological markers. This frequently involves intracellular markers, which provide information about proteins and other characteristics inside the cells.
Developing a panel capable of detecting these markers requires careful customization. The selected markers must work together within the analytical platform, and the resulting assay must be evaluated to ensure that it can identify the intended cell populations consistently.
Traditional spectral flow cytometry panels can require extensive development and optimization. According to the review, creating an equivalent panel containing more than 20 markers may take approximately six months. This lengthy development period can delay the availability of important biomarker measurements and create additional work for clinical research teams.
Panel development can also affect the number of cells available for subsequent immune-monitoring techniques. When complex analyses require extensive customization or consume limited specimen material, fewer cells may remain available for additional testing. This is a relevant concern when working with rare immune-cell populations, where the number of cells in each sample may already be limited.
The review describes mass cytometry as an alternative approach that can help address these analytical challenges. Using this technology, a mass cytometry assay containing more than 20 markers can be qualified in approximately three weeks, compared with approximately six months for an equivalent spectral flow cytometry assay.
This difference in development timelines could help clinical-trial sponsors establish specialized immune-monitoring capabilities more quickly. It may also allow research teams to adapt biomarker strategies as their understanding of a drug’s biological activity develops.
Faster Assay Qualification Can Support Clinical Development
The ability to develop and qualify complex analytical panels within a shorter period can be valuable throughout oncology drug development. Early-phase clinical trials frequently seek to establish whether an investigational therapy is affecting its intended biological target and whether those effects are associated with changes in relevant immune-cell populations.
In these studies, pharmacodynamic biomarkers can provide evidence of biological activity beyond conventional clinical measurements. For example, monitoring Tregs may help researchers understand whether an investigational treatment is influencing immune regulation in a manner consistent with its proposed mechanism of action.
However, the usefulness of these measurements depends on the quality of the assay. A panel must be capable of identifying the relevant cells accurately, and its performance must remain consistent when applied to specimens collected at different clinical sites.
A faster qualification process could help sponsors introduce or refine biomarker assays without waiting several months for panel development. It may also provide greater flexibility when a clinical program requires additional markers or more detailed characterization of immune-cell subsets.
The review highlights the potential value of combining mass cytometry with standardized sample stabilization. The two approaches address different parts of the same challenge: fixation helps preserve the biological material, while mass cytometry supports the detailed characterization of immune-cell populations.
Together, these methods can help create a more consistent workflow for collecting, transporting and analyzing specimens in multinational oncology studies.
Experience From Roginolisib Clinical Trials
The publication draws on Teiko’s work supporting the first-in-human clinical study of roginolisib and its mass cytometry activities across three ongoing roginolisib trials.
Roginolisib is an investigational conformation-selective PI3K-delta inhibitor developed by iOnctura. The compound is designed to lock the PI3K-delta enzyme in its inactive state. PI3K-delta is involved in signaling pathways that regulate immune-cell activity, making it a relevant target for research into cancer and the tumor immune environment.
Because the drug’s mechanism involves a pathway associated with immune regulation, detailed immune monitoring can provide important information about its biological effects. Assessing changes in specific immune-cell populations may help investigators understand how roginolisib influences the immune system in patients participating in clinical trials.
The use of mass cytometry allows researchers to examine multiple cellular markers simultaneously, providing a broader view of immune-cell characteristics than approaches that measure only a limited number of markers. This is particularly relevant when the research objective involves rare populations such as Tregs.
At the same time, reliable interpretation of these results depends on the quality of the blood specimens. If cells deteriorate during transportation, the resulting measurements may not accurately reflect the biological state at the time of collection. Stabilizing blood at clinical sites is intended to reduce this source of variability.
By applying these approaches across roginolisib studies, Teiko and iOnctura are using their clinical research experience to demonstrate how sample-handling procedures and analytical technologies can work together to support immune monitoring.
The review provides a practical discussion of the operational considerations involved in implementing these methods in global trials, where the ability to preserve samples and generate comparable results across sites is especially important.
iOnctura Highlights the Value of Standardized Sample Handling
Michael Lahn, MD, Chief Medical Officer of iOnctura, emphasized the importance of sample stabilization and centralized analysis for multinational clinical research.
“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,” Lahn said.
His comments underscore the importance of consistent specimen handling when clinical programs involve sites across multiple countries. Differences in shipping times, customs procedures and local logistics can introduce variability that is unrelated to the treatment itself. Standardizing the stabilization process at the point of collection may help reduce these differences and improve confidence in the resulting biomarker measurements.
For iOnctura, the approach is intended to support a clearer assessment of roginolisib’s activity in patients enrolled in its clinical studies. More reliable immune-monitoring data can help researchers investigate how the investigational treatment affects relevant immune populations and evaluate its biological activity during clinical development.
Implications for Future Precision Oncology Research
The findings discussed in the Bioanalysis review have broader relevance for clinical-trial sponsors developing therapies that require detailed immune monitoring. As oncology research increasingly incorporates biomarker-driven approaches, the ability to measure rare immune-cell populations consistently will remain an important part of clinical development.
Traditional specimen transportation and assay-development procedures can create delays and reduce the availability of usable data. These limitations may be particularly pronounced in early-stage studies, where researchers are still investigating a treatment’s mechanism of action and determining which biomarkers are most informative.
Clinical-site fixation offers a way to reduce the risk of specimen loss associated with extended transportation of live blood. Mass cytometry, meanwhile, provides an approach for developing complex panels more rapidly, potentially shortening the time needed to establish detailed immune-monitoring assays.
The combination may be especially useful in trials involving multiple international locations, where standardized sample processing and centralized analysis can help improve consistency. It may also support studies that depend on small immune-cell populations, for which sample degradation and limited cell availability can have a disproportionate impact on results.
Although the review focuses on Treg monitoring and the companies’ experience with roginolisib, the underlying challenges are relevant to a wider range of oncology and immunology programs. Other investigational therapies may also require researchers to track changes in rare immune-cell populations to understand treatment activity, assess pharmacodynamic effects or investigate potential relationships between biological responses and clinical outcomes.
The approaches described in the publication could therefore inform the design of future biomarker strategies, particularly for studies that require detailed cellular analysis across geographically distributed clinical sites.
Supporting More Consistent Biomarker Data in Global Trials
Through its collaboration with iOnctura, Teiko is highlighting how improvements in sample stabilization and analytical technology can address practical barriers in multinational oncology research. The review outlines two complementary solutions: fixing blood specimens at clinical sites with the TokuKit system to reduce time-dependent cell loss, and using mass cytometry to qualify complex panels more quickly than equivalent spectral flow cytometry assays.
According to the publication, these methods can remove the 72-hour live-specimen shipping limitation and reduce the development timeline for a panel containing more than 20 markers from approximately six months to around three weeks.
The companies’ experience across three ongoing roginolisib trials provides the basis for discussing how these approaches can be applied in clinical research. By improving specimen preservation and accelerating assay qualification, the methods are intended to help sponsors obtain more consistent immune-monitoring data and better understand the biological effects of investigational cancer therapies.
The publication in Bioanalysis adds to the discussion of operational and technological approaches that may strengthen biomarker assessment in global oncology trials. As precision oncology programs increasingly depend on detailed immune profiling, reliable sample handling and efficient analytical development will remain important components of clinical research.
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.