# Comprehensive Assessment of Cancer Immunotherapy Response

> **NIH NIH R44** · AIQ GLOBAL INC · 2022 · $1,012,057

## Abstract

Project Summary
 Immune checkpoint inhibitors (ICIs) are transforming cancer care resulting in robust and durable disease
control in many advanced malignancies. Despite their growing adoption, however, ICIs are only effective for
less than 30% of patients and can cause significant immune-related adverse events (irAE) in up to 60% of
treated patients. Early determination of which patient will respond and/or develop irAE remains a great chal-
lenge due to the complex interplay of tumor response, toxicity in critical organs, and overall patterns of immune
activation. Critically missing is a comprehensive assessment of therapeutic response and prediction of toxicity
that would provide oncologists with timely, actionable information to optimally balance benefits and risks, im-
prove 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 rely on
manual evaluation of a subset of disease sites, which is both laborious and subjective, particularly in cases of
metastatic disease. Furthermore, the unique mechanism of action of ICIs often gives rise to specific imaging
patterns of tumor response (e.g, pseudoprogression) that cannot be easily resolved using current methods.
Disease response, organ toxicity, and lymphoid tissue immune activation are interdependent; information on all
three factors 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 to optimize patient management.
 In this Phase II SBIR project, AIQ Solutions will build on the successful completion of our Phase I project to
bridge the gap between clinical need and existing products. Based on our Phase I results, our software will
meet the unique–and currently unmet–needs of immunotherapy patients with metastatic cancer by providing a
comprehensive analysis of immunotherapy response including: (1) quantify treatment effectiveness in all
lesions, (2) quantify immune-related toxicities in critical organs, (3) calculate the probability of achieving opti-
mal overall clinical effectiveness, and (4) calculate the probability of irAE. To do this, we propose the following
aims and milestones. (1): Complete development, refine performance, and validate the TRAQinform Immuno
technology. (2) Perform usability assessment of the TRAQinform Immuno technology. (3) Evaluate actionable
information output from the TRAQinform Immuno technology in a prospective, non-interventional clinical study.
Upon successful completion of the SBIR Phase II, we will have completed development and basic validation of
TRAQinform Immuno technology. Additionally, we will be positioned to submit for FDA clearance...

## Key facts

- **NIH application ID:** 10480635
- **Project number:** 2R44CA257253-02
- **Recipient organization:** AIQ GLOBAL INC
- **Principal Investigator:** Timothy Perk
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,012,057
- **Award type:** 2
- **Project period:** 2020-09-30 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480635

## Citation

> US National Institutes of Health, RePORTER application 10480635, Comprehensive Assessment of Cancer Immunotherapy Response (2R44CA257253-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10480635. Licensed CC0.

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