Novigenix & Radbound University Medical Center Discover the First Blood-Based ImmunoTranscriptomic Biomarkers for Response to Anti-PD-1 Therapy

Novigenix SA recently announced release of the article Whole Blood Transcriptome Profiling Identifies DNA Replication and Cell Cycle Regulation as Early Marker of Response to Anti-PD-1 in Patients with Urothelial Cancer. Immune checkpoint inhibitors (ICIs) have become one of the main treatments for patients with metastatic urothelial cancer. Although ICIs are highly effective with durable results in some patients, only a minority respond and benefit from the therapy. There is therefore a significant unmet medical need for accurate liquid biopsy precision solutions that can select and monitor patients during ICI therapy.

Dr. Niven Mehra, Department of Medical Oncology at Radboud University, The Netherlands, said “Early blood-based response biomarkers may provide a reliable and convenient way to determine whether ICIs are effective before imaging is available, usually after 12 weeks, and can be particularly useful for those with equivocal imaging.”

The study leveraged Novigenix core competencies in Immuno-Transcriptomics and machine learning for development of biomarkers and predictive algorithms. In whole blood of patients with clinical benefit, genes involved in DNA replication and cell cycle regulation were upregulated after 2 to 6 weeks of treatment. Dr. Laura Ciarloni, Director Clinical and Scientific Affairs at Novigenix, underlined “This study highlights the value of whole-blood transcriptomics platform of Novigenix, LITOseek, for generating insights into the immune response to anti-PD-1 therapy.”

Dr. Sahar Hosseinian, CTO of Novigenix, added “This study demonstrates the power of whole-blood immuno-transcriptomics for discovery of clinically actionable biomarkers that support drug development. This new class of liquid biopsy precision oncology solutions may support oncologists in the treatment of urothelial cancer patients to significantly improve personalized ICI therapy and patient outcomes.”

Novigenix is a precision medicine biotech providing a new understanding of the human host response to cancer and its response to therapy. The Company was founded on the vision that Immuno-Transcriptomics will bring unprecedented advances in diagnosing and treating cancer patients, leading to significant improvement in healthcare. Novigenix’s unique Immuno-Transcriptomic platform enables an accelerated identification of disease specific mRNA signatures of immune cells, which combined with machine learning and predictive algorithms provide new insights into onset and progression of disease. For more information, visit

The Liquid Immuno-Transcriptomic Sequencing Platform of Novigenix, LITOseek, analyzes the gene expression modifications (mRNA signatures) induced by the host immune response to various triggers, such as onset of cancer. Disease specific algorithms are developed through application of Artificial Intelligence on patient mRNA signatures in combination with clinical and medical parameters. The LITOseek platform has been designed and optimized for development of precision oncology solutions based on the human Immuno-Transcriptome, with continuous improvement of predictive and adaptive algorithms.