Immunis.AI Releases Prospective Study Results of Its RNAseq-Based Liquid Biopsy in Early-Stage Prostate Cancer

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ROYAL OAK, Michigan – (COMMERCIAL THREAD) – Immunis.AI, Inc., an immunogenomics platform company that develops non-invasive blood tests to optimize patient care, today announced the release of pivotal results from its clinical trial, Evaluation of ” An RNAseq-based Immunogenomic Liquid Biopsy Approach in Prostate Cancer Stage, in the review Cells.

The study results validate the potential of the company’s proprietary Intelligentia platform to detect cancer at an early stage and stratify risk in men considering active surveillance for prostate cancer. The results also illustrate the potential of the company’s proprietary immunogenomics platform to address screening, therapeutic decision making and minimal detection of residual disease.

This is the first of three large prospective studies conducted and designed to demonstrate the power of the company’s proprietary Intelligentia platform for the early detection of cancer and the assessment of disease aggressiveness.

Main conclusions:

In this prospective study, the main objective was to develop and validate a model for the identification of clinically significant prostate cancer. Peripheral blood samples were collected from 1,018 previously undiagnosed men undergoing prostate biopsy and chronologically divided into independent training (n = 713) and validation (n = 305) sets. Whole transcriptome RNA sequencing was performed on isolated phagocytic CD14 + monocytes and non-phagocytic CD2 + lymphocytes and their gene expression levels were used to develop a predictive model correlated with clinically unfavorable pathological features of prostate cancer. localized at an early stage.

  • The immunotranscriptomic model, emphasizing both the mechanism of tumor phagocytosis and the anti-tumor immune response, combined with clinical risk parameters, gave an AUC (area under the curve) of 0.83 on the independent validation set (n = 305).

  • Notably, given that the average age at diagnosis of prostate cancer is 66 years, the model was the most powerful predictor of adverse pathology in men aged 60 to 66 with an AUC of 0.91 in the independent validation set.

  • Several cancer-related pathways appear to be significantly represented in the set of model genes, including hedgehog signaling, epithelial mesenchymal transition, PDL1 and PD1 checkpoints, and poor transcriptional regulation in cancer.

“The strong AUC generated in the study demonstrates high sensitivity and negative predictive value,” said Dr. Kirk Wojno, medical director of Immunis.AI, “which together support our Intelligentia platform’s ability to to provide actionable information that can help urologists distinguish prostate cancer patients who can safely choose active surveillance from those with aggressive occult disease requiring immediate intervention.

“Immunis.AI is developing models that incorporate both novel disease-related biomarkers as well as the body’s immune response to that disease, so that a single blood sample can be bioinformatically assessed for the presence of multiple diseases simultaneously.” , said Dr Leander Van Neste, Scientific Director of Immunis.AI.

“The data provides strong evidence that the Intelligentia platform offers a combination of sensitivity and specificity for early stage disease with the flexibility to interrogate multiple types of cancer,” added Van Neste. “We are encouraged by these results and excited about the potential of our multi-cancer screening platform. “

About Immunis.AI, Inc.

IMMUNIS.AI is a privately held immunogenomics company with a patented liquid biopsy platform that offers unique disease biology information and individualized assessment. The Intelligentia platform combines the power of the immune system, RNAseq technology and machine learning (ML) for the development of disease-specific signatures. This proprietary method uses the immune system monitoring apparatus to overcome the limitations of circulating tumor cells (CTC) and cell-free DNA (cfDNA). The platform improves disease detection at an early stage, to the point of immune breakout, when there is the greatest opportunity for a cure. For more information, please visit our website: https://immunis.ai/.


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