Overview

ICI (Immune checkpoint inhibitor) therapy, which is now approved for use in most common cancers, represents one of the greatest advances in cancer therapy. However, in many cases these promising treatments cause immune-related adverse events (irAE). These unpredictable, possibly severe, and potentially permanent toxicities occur when ICI causes an autoimmune attack on normal organs such as the liver, lungs, and GI tract. Years after ICIs entered the market, we still have no reliable means to diagnose, predict, or monitor these toxicities. Physicians are therefore left guessing which patients may tolerate some of the most effective, and also most toxic, cancer treatment regimens, resulting in both potentially avoidable morbidity and under-use of treatment. Moreover, once these toxicities occur, optimal treatment remains unclear, leaving many patients exposed to prolonged, high-dose steroids, which themselves may convey substantial toxic effects and delay administration of additional anti-cancer therapy.
 
OncoSeer’s multimarker blood tests will be game-changing for physicians who prescribe ICI therapy. These blood tests will give a simple predictive score so that physicians will know whether a patient is at low risk or at high risk for irAE. For patients who are currently assumed  to be too high risk for ICI therapy (i.e., patients with a history of certain autoimmune diseases), the blood tests will identify the subset of low risk individuals and thereby expand the use of ICI therapy. For patients who are already receiving ICI therapy, the blood tests will aid in the diagnosis of irAE, which are far more difficult to diagnose than toxicities of other cancer treatments such as chemotherapy, radiation therapy, and targeted therapy.

Technology

The Problem

  • Immunotherapy (immune checkpoint inhibition) is one of the greatest advances in cancer treatment; however, these promising treatments can cause immune-related adverse events (irAE) which are unpredictable, severe, and potentially fatal attacks on major organ systems
  • irAE prevent the full potential of immunotherapy
  • There are currently no reliable tools for predicting / diagnosing / monitoring irAE

The Solution

  • We are developing a Cancer Immunotherapy Toxicity Prediction blood test that will identify patients who are likely to develop irAE
  • This prediction allows physicians and patients to make informed decisions on the use of immunotherapy
  • Expanded use: Early-stage cancer & History of autoimmune disease
  • Modified use or increased monitoring: Patients at high risk of toxicity

The Problem

irAE affect almost any organ system

irAE occur at any time

Pneumonitis  after 3 doses

 

Antiphospholipid syndrome  after 4 doses

  • Immunotherapy (immune checkpoint inhibition) is one of the greatest advances in cancer treatment; however, these promising treatments can cause immune- related adverse events (irAE) which are unpredictable, severe, and potentially fatal attacks on major organ systems
  • irAE prevent the full potential of immunotherapy
  • There are currently no reliable tools for predicting / diagnosing / monitoring irAE

The Solution

  • We are developing a Cancer Immunotherapy Toxicity Prediction blood test that will identify patients who are likely to develop irAE
  • This prediction allows physicians and patients to make informed decisions on the use of immunotherapy
  • Expanded use: Early-stage cancer & History of autoimmune disease
  • Modified use or increased monitoring: Patients at high risk of toxicity

Oncology Patient

Baseline Blood Sample

Multimarker Test

Algorithm

Risk Score

Treatment

Oncology Patient

Termed immune-related adverse events (irAE), ICI (Immune checkpoint inhibitor) toxicities occur when treatment causes an autoimmune attack against normal tissues and organs. While most patients tolerate ICI relatively well, in some cases irAE may be severe and even permanent. Furthermore, they are largely unpredictable. As a result, irAE prevent ICI therapy from reaching its true potential:

  • Toxicity concerns limit the use of ICI in patients with autoimmune disease, which occur in approximately 15% of patients with common cancers such as lung cancer.
  • Toxicity concerns limit the use of the most aggressive and effective forms of ICI, such as combination immunotherapy, thereby depriving patients of access to potentially curative therapy.
  • irAE treatment consists primarily of prolonged treatment with high-dose steroids, which may delay subsequent ICI use and itself may convey substantial toxicity.

Informing Cancer Immunotherapy Decisions

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