ROYAL OAK—Immunis.AI Inc., a biotech company developing noninvasive blood-based tests for disease, announced the publication of pivotal results from its clinical trial, Evaluation of an RNAseq-based Immunogenomic Liquid Biopsy Approach in Early-Stage Prostate Cancer, in the journal Cells.

Study findings validate the potential of the company's proprietary Intelligentia platform to detect early-stage cancer and to stratify risk in men considering active surveillance of prostate cancer. The results also illustrate the potential of the company's proprietary immunogenomic platform to address screening, treatment decision making, and minimal residual disease detection.

This is the first of three large, prospective studies completed and designed to demonstrate the power of the company's proprietary Intelligentia platform for early-stage cancer detection and the assessment of disease aggressiveness.

In this prospective study, the primary 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 split chronologically 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 that correlates to adverse pathologic features in early stage, clinically localized prostate cancer.

  • The immunotranscriptomic model, emphasizing both the tumor phagocytosis mechanism and the anti-tumor immune response, combined with clinical risk parameters, yielded an AUC (area under curve) of 0.83 on the independent validation set (n=305).
  • Notably, considering the average age at diagnosis of prostate cancer is 66, the model was the strongest predictor for adverse pathology in men 60-66 years of age with an AUC of 0.91 in the independent validation set.
  • Several cancer-related pathways appear to be significantly represented in the model gene set, including hedgehog signaling, epithelial mesenchymal transition, PDL1 and PD1 checkpoint, and transcriptional misregulation in cancer.

"The strong AUC generated in the study demonstrate high sensitivity and negative predictive value," said Kirk Wojno, chief medical officer of Immunis.AI, "which together support the ability of our Intelligentia platform to deliver actionable information that can help urologists distinguish prostate cancer patients who may safely choose active surveillance from those who are harboring occult aggressive disease requiring immediate intervention."

Added Leander Van Neste, chief scientific officer of Immunis.AI: "The data provide strong evidence that the Intelligentia platform delivers a combination of sensitivity and specificity for early-stage disease with the flexibility to interrogate multiple cancer types. We are encouraged by these results and excited about the potential of our platform for multi-cancer screening."

The Intelligentia platform combines the power of the immune system, RNAseq technology and Machine Learning for the development of disease-specific signatures. This proprietary method uses the immune system's surveillance apparatus to overcome the limitations of circulating tumor cells (CTCs) and cell free DNA (cfDNA). The platform improves detection of early-stage disease, at the point of immune-escape, when there is the greatest opportunity for cure. For more information, visit https://immunis.ai/.