The DiviTum® TKa Test – A Solution for the Drug Development Continuum
A biomarker can contribute essential data during preclinical and clinical drug development:
- Add valuable insight to tollgate decisions to steer future development.
- Provide key information for pipeline strategy.
- Give dose-response information and early signals of efficacy.
- Provide mode of action evidence of target efficacy.
- Bridge data between cell cultures, animal models, and human clinical studies.
- Predict outcome and give early indication of response/progression in target population.
- Help stratify patients into different levels/groups of response to therapy.
- Increase approval probability and speed to market, reduce attrition and cost.
A liquid proliferation biomarker test like DiviTum® TKa can add value when developing oncology drugs.
Tumors are characterized by uncontrolled cell growth. Biomarkers that measure cell proliferation activity can be used to measure cell growth rate and can provide an early indication of dose response and in vitro efficacy. Further on, biomarkers can assist in tumor type selection, predict outcomes, and monitor treatment efficacy. As an alternative to imaging, which look at tumor volume change reflecting what has already happened, DiviTum® TKa analyzes the current tumor growth rate and predicts future response and time to progression. Ki-67, which requires a biopsy, has been used for a long time to measure cell proliferation. Ideally, a proliferation biomarker can be used in studies both based on cell-cultures, animal tumor models, and patient blood samples, providing a bridge between preclinical and clinical studies. Thymidine kinase activity (TKa) is such a biomarker.
“Project Optimus”
Under the FDA, the Oncology Center of Excellence (OCE) has recently initiated the “Project Optimus” initiative to reform the dose optimization and dose selection paradigm in oncology drug development. The current paradigm for dose selection too often leads to doses and schedules of targeted therapies that are inadequately characterized before initiating registration trials, which further lead to selection of suboptimal doses with toxicities that limit the options for receiving the benefit from therapies. The goal of Project Optimus is to identify new dose-finding and dose optimization paradigms that emphasize selection of a dose that maximizes not only the efficacy of a drug but the safety and tolerability as well. Thymidine kinase activity (TKa) can be used as a biomarker for dose optimization.
The DiviTum® TKa test has been shown to be valuable in assessing oncology — and immuno-oncology compounds.
There are many novel compounds within oncology aiming to slow or shut down tumor cell growth. Many different signaling pathways are targeted that inhibit the cell cycle and shut down uncontrolled cell proliferation. The DiviTum® TKa test has been demonstrated to be a strong pharmacodynamic tool for new, targeted drugs like CDK4/6 inhibitors and an early efficacy assay for evaluating endocrine therapy. DiviTum® TKa is FDA 510k cleared (and CE marked) for monitoring postmenopausal women with hormone receptor-positive metastatic breast cancer and is clinically validated in collaboration with SWOG and many leading cancer institutions.
New Biomarkers Are Needed
In the era of immuno-oncology and targeted therapy, new markers are needed to provide information on surrogate endpoints that predict clinical outcome. The DiviTum® TKa test has demonstrated the ability to predict and reflect the efficacy of immune checkpoint inhibitors and the immune response they trigger. Hence, DiviTum® TKa is an assay that can assist researchers in determining efficacy for compounds with different mechanisms of action.
Pharma companies work with Biovica and utilize the DiviTum® TKa assay in clinical studies in the following ways.
In Clinical Trials, Thymidine Kinase activity (TKa) can be used for:
- Measuring cell proliferation
- Predictive (Patient Stratification) purposes
- Prognostic purposes
- Treatment Monitoring
- Dose Optimization
Our pharma partner team is very experienced within pharma-needs/services, including pre-clinical, clinical, and companion diagnostic (CDx) collaborations. The pharma partner team includes clinical-, regulatory-, technology-, and pharma collaboration experience and expertise. We focus on solutions from a routine laboratory workflow and assay robustness perspective, as well as assay distribution and support. Optimizing assay turnaround-time and being mindful of global registration and market access are parts of our team’s DNA.
Contact us to discuss how the DiviTum TKa test can assist your oncology pipeline development.