# Comprehensive Assessment of Cancer Immunotherapy Response

> **NIH NIH R43** · AIQ GLOBAL INC · 2020 · $388,323

## Abstract

Project Summary
 Immune checkpoint inhibitor (ICIs) immunotherapies can result in robust and durable disease control in
many advanced malignancies, and their use is transforming cancer care. Despite the growing adoption,
however, ICIs are effective in <30% of patients and can cause significant immune-related adverse events
(irAEs) in up to ~60% of treated patients. Early determination of which patient will respond and/or develop
irAEs remains a great challenge due to the complex interplay of tumor response, toxicity in critical organs, and
overall patterns of immune activation. Further complicating their use, ICI costs are high ($100k-$250k
annually/patient; total Medicare Part B payment for ICIs in 2018 >$4 billion). A comprehensive assessment of
early ICI therapeutic response and toxicity would provide oncologists with timely, actionable information to
better balance benefits and risks, improve patient outcomes, reduce toxicities and lower healthcare costs.
 Molecular imaging is an invaluable tool for assessing spatial and temporal changes in tumors, damage to
critical organs and immune activation during immunotherapies. Unfortunately, current assessments require
manually evaluating a subset of disease sites, which is both laborious and subjective. Immunotherapies’
unique mechanism of action often gives rise to novel imaging patterns of tumor response (e.g.
pseudoprogression) that cannot be easily resolved by current methods. Disease response, organ toxicity, and
lymphoid tissue immune activation are interdependent. Information on all three of these aspects of response
must be known to capture the complete landscape of immunotherapy response. The status quo in assessing
response not only fails to fully extract clinically significant information from the imaging data, but also provides
very limited information to medical oncologists for improved overall patient management.
To address this unmet need, AIQ Solutions (Madison, WI) proposes to develop
ImmunIQ
, a software
product that provides a comprehensive view of immunotherapy response. Specifically, ImmunIQ will
automatically and simultaneously assess: (1) response of all tumor lesions, (2) immune-related toxicities in
critical organs, and (3) immune activation. Upon successful completion of Phase I, we will have a functional
software prototype. In Phase II, we will clinically validate the platform with outcome and irAE data and develop
a prototype ready for commercialization and FDA 510(k) submission.

## Key facts

- **NIH application ID:** 10143575
- **Project number:** 1R43CA257253-01
- **Recipient organization:** AIQ GLOBAL INC
- **Principal Investigator:** ROBERT JERAJ
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $388,323
- **Award type:** 1
- **Project period:** 2020-09-30 → 2021-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10143575

## Citation

> US National Institutes of Health, RePORTER application 10143575, Comprehensive Assessment of Cancer Immunotherapy Response (1R43CA257253-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10143575. Licensed CC0.

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