# Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns Disease

> **NIH NIH K23** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2022 · $189,342

## Abstract

This project will evaluate predictive biomarkers of response to anti-tumor necrosis factor alpha (anti-TNF)
therapy in early Crohn's disease (CD) patients. Candidate: The primary objective of this application is to
support Dr. Ryan Ungaro's career development into an independent patient-oriented investigator in the field of
personalized medicine for inflammatory bowel disease (IBD) patients. Dr. Ungaro's career goal is to become
an independent researcher and leader in the application of predictive biomarkers and models to select the best
treatment and optimize care for recently diagnosed IBD patients. Dr. Ungaro's proposed training activities are
in four areas: 1) advanced biostatistical analysis, 2) predictive biomarker analysis, 3) computational genomics,
and 4) principles of immune monitoring. To achieve this, he has assembled a mentoring and advisory team led
by Dr. Judy Cho, Director of the Charles Bronfman Institute of Personalized Medicine and an expert in
translational genomics, and Dr. Bruce Sands, Chief of the Division of Gastroenterology, who has expertise in
clinical and translational investigation of IBD therapeutics, having driven much of the pioneering research in
anti-TNFs. Environment: The Icahn School of Medicine at Mount Sinai has a strong tradition of outstanding
research and is one of the top 20 medical schools in NIH funding. The Mount Sinai Division of
Gastroenterology is consistently considered one of the top 10 divisions in the country by US News and World
Report and is an international leader in IBD research and clinical care. Research: CD is a chronic,
progressive, inflammatory condition affecting the gastrointestinal tract. Anti-TNF medications have vastly
improved the treatment of CD patients, however a significant number of individuals do not respond to these
agents which are very costly and have potentially fatal side effects. New classes of medications for CD are
being released bringing the opportunity for personalized medicine. Clinicians will need the tools to help decide
which medication will work best for each individual CD patient. This will be particularly important in recently
diagnosed patients since effective early treatment can decrease long-term complications. Therefore our
specific aims are to (1) determine the association of peripheral blood proteomic markers with response to anti-
TNF (2) assess the association of intestinal tissue gene expression markers with anti-TNF response and (3)
explore the mucosal immune architecture and predictive capacity for anti-TNF response of single cell RNA
sequencing (scRNASeq) of intestinal biopsies. We will study recently diagnosed CD patients (within 2 years of
diagnosis) from 3 prospective cohorts with biosamples: a population-based IBD inception cohort, a multi-center
cohort of recently diagnosed pediatric CD patients, and a single-center biorepository of IBD patients linked to
health records data. In addition, a cohort of recently diagnosed CD patients will be re...

## Key facts

- **NIH application ID:** 10324596
- **Project number:** 5K23DK111995-04
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** RYAN UNGARO
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $189,342
- **Award type:** 5
- **Project period:** 2019-04-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10324596

## Citation

> US National Institutes of Health, RePORTER application 10324596, Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns Disease (5K23DK111995-04). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10324596. Licensed CC0.

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