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Immunis.AI Announces Publication, in The Journal of Urology, of Results from Blood-Based Immune Profiling Study for Prostate Cancer Patients

IMMUNIS.AI, an immunogenomics company developing blood-based cancer surveillance technologies, today announced that results from a prostate cancer risk stratification study evaluating the company's novel blood-based liquid biopsy platform were published in The Journal of Urology. The results validate the ability of the platform to accurately stratify risk for patients with diagnosed prostate cancer. In the study, Immunis.AI's non-invasive platform promises new standards of testing for active surveillance patients.

"The test is designed to non-invasively identify the presence of aggressive cancer in men already diagnosed with prostate cancer who are on or are considering starting active surveillance," said Kirk Wojno, M.D., Chief Medical Officer, Immunis.AI. "When used to aid in decisions concerning active surveillance of prostate cancer, our test has the potential to replace periodic invasive active surveillance procedures, including prostate tissue biopsies, with a simple blood test."

Currently, only ~30% of patients remain compliant with active surveillance protocols, which involve having multiple biopsies, currently deemed the gold standard for surveillance. This alone limits the effectiveness of surveillance leading to worsened patient outcomes and missed opportunities for cure.

"One of the big challenges in prostate cancer management is distinguishing those patients with early prostate cancer who are appropriate for active surveillance from those who need to be aggressively treated. The novel approach published by Immunis.AI utilizes the RNA signature created by the immune system's response to cancer. The potential to better select patients would mark a significant advance in prostate cancer active surveillance," said Philip Kantoff, M.D., advisor to the company and author of the publication.

Study Design and Results

In the study, peripheral blood samples were collected from 706 subjects with confirmed prostate cancer based on positive biopsy. Immune cells were isolated from these blood samples, and gene expression levels in the patient's lymphocytes and monocytes were identified using RNA sequencing to evaluate the prostate cancer-specific immune profile of each patient.

To characterize each patient's immune profile, gene expression levels in their lymphocytes were subtracted from gene expression levels in their monocytes, a process called subtraction-normalization that eliminates the confounding effects of patient-to-patient variability in gene expression levels. Using AI predictive modeling, the normalized immune profile of each patient was evaluated against known immune signatures for indolent or aggressive prostate cancer.

The model produced an individual risk score for each patient which categorized them into one of three groups: very low-risk (90% NPV), low-risk and high-risk for harboring clinically significant prostate cancer.

Data from the study shows that the immune profile is effective as a biomarker of prostate cancer severity and is significantly better than clinical factors alone in predicting which patients have aggressive cancer. The individual risk score produced by the model was successful at accurately establishing the likelihood of each patient's cancer being clinically significant and requiring treatment.

"When a patient has cancer, their immune cells arm themselves to fight it off, which is reflected in changing levels of gene expression in those cells," said Wojno. "While the actual gene expression levels in lymphocytes and monocytes may vary from patient to patient, the relationship between the two gene expression levels produces a distinct immune signature for patients with indolent cancer and those with aggressive cancer, helping to identify the presence and severity of cancer without making a general comparison to a standardized patient population. By looking at the personalized immune profile specific to each patient instead of comparing to population averages, we can more accurately assess aggressiveness of an individual's cancer and better inform treatment decisions."

"Modifying active surveillance protocols based on the patient's immune response to their own prostate cancer is a completely novel and very exciting concept. Immunis.AI?s liquid biopsy test represents a new frontier to developing dynamic risk-based active surveillance strategies that can improve patient care, improve the active surveillance experience and lessen the patient burden of intensive monitoring, decreasing the need for surveillance prostate biopsies," said Jason Hafron, M.D., Chief Medical Officer, Michigan Institute of Urology and author of the publication.

Immunis.AI intends to commercialize the test in the U.S. and Europe. In the U.S. alone, the total addressable market is estimated to be up to $4 billion.

About Immunis.AI, Inc.

Immunis.AI is a privately held company committed to making a global impact by empowering patients and their physicians with actionable information for disease management. Our patented platform leverages the body's own immune defense system, state-of-the-art analytical methods, and AI and machine learning to provide unique real-time insights into a patient's disease. Our vision is to leverage our validated platform to deliver a suite of non-invasive, blood-based, assays that can have broad use in active surveillance and early detection. Our mission is to provide tools for physicians and patients that can be used to more accurately make critical decisions on treatment plans for patients in the most comfortable and cost-efficient manner. For more information, please visit our website: https://immunis.ai/.

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