CellCarta has a long history of working with its biopharmaceutical partners to support oncology therapeutic development.
With our deep scientific expertise across multiple platforms, we are uniquely positioned to support targeted biomarker assay development for exploratory, secondary, and primary endpoints, as well as the global deployment of assays to support global trials .
Through its immuno-monitoring capabilities, including
CellCarta provides unmatched expertise to support the development of cancer immune therapies, including:
Our team of scientists successfully developed flow cytometry assays to measure a variety of immune checkpoint proteins in cryopreserved PBMC and whole blood, including PD-1, LAG-3, and PD-L1.
Other assays were developed for this platform including one to monitor receptor occupancy of therapeutic antibodies.
CellCarta offers access to world-class histopathology and molecular pathology services, for the development of clinical biomarkers and companion diagnostics (CDx).
Various immunotherapy biomarkers were already developed and validated by our team for rapid and productive immunohistochemistry (IHC) assays.
Digital pathology and all the technologies it offers might be well suited for the analysis of cancer and immune cells in clinical research.
Our digital pathology capabilities are tailored to the analysis of tumor and immune cells in clinical research.
As validation can be a challenge, we’ve developed a roadmap for oncology assay validation in regulated trials, especially immunotherapies.
Leveraging an outstanding combination of state-of-the-art mass spectrometry platforms and expertise in cell biology and bioinformatics, CellCarta supports clinical research as a specialized CRO partner.
CellCarta uses robust and proven proteomic approaches to identify neo-epitopes, drug targets, and candidate biomarkers.
Our MRM platform was used in several projects investigating correlations between clinical outcomes and presence of biomarkers, which led to the identification of several potential biomarkers.
Using the same MRM platform, CellCarta develops highly quantitative and specific mass spectrometry-based bioanalytical assays for the measurement of biomarkers and biotherapeutics, in support to clinical and pharmacokinetic (PK) studies.
We can monitor the expression of soluble B-cell maturation antigen (BCMA) in plasma samples and measure clinically relevant biomarkers in readily available formalin-fixed paraffin embedded (FFPE) samples.
We also have a proven track record of using mass spectrometry for the development of commercialized diagnostics, including a non-invasive blood-based diagnostic test to identify benign lung nodules.
Here are some examples of work we did in the field of oncology:
Biomarker recommendation for PD‐1/PD‐L1 immunotherapy development in pediatric cancer based on digital image analysis of PD‐L1 and immune cells.
Discovery of a putative blood-based protein signature associated with response to ALK tyrosine kinase inhibition.
Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial.
These studies reflect our role in biomarker-driven drug development programs, from pre-clinical to late-stage clinical phase.
As a global oncology CRO partner, CellCarta supports end-to-end clinical development in immuno-oncology, from biomarker assay design to validation, deployment, and regulatory support.
Our oncology services include:
With published expertise and a proven regulatory track record, CellCarta delivers precision and reliability for your most complex oncology trials.