# Novel Oral Yeast Immunotherapies for Ulcerative Colitis (Fast-track)

> **NIH NIH R44** · FZATA, INC. · 2022 · $855,001

## Abstract

Abstract
Ulcerative colitis and Crohn’s disease are major forms of inflammatory bowel disease (IBD), which is
characterized by chronic intestinal inflammation and gut microbiota dysbiosis. IBD has been associated with
poor quality of life and often results in complications requiring hospitalizations and surgical procedures that
causes significant morbidity and financial losses in the US. In past decade, anti-tumor necrosis factor alpha
(TNF-a) have become the cornerstone of treatment for IBD, but the long-term use of these systemically
delivered biologics is often associated with the loss of effects and the risks of generalized immunosuppression.
To overcome the hurdles, we developed an oral immunotherapeutic lead, designated as FZ006, by utilizing a
probiotic Saccharomyces boulardii to deliver a potent bi-specific neutralizing antibody against human TNF-a to
the intestines in order to treat ulcerative colitis. In our preliminary studies, we generated a prototype of S.
boulardii strain secreting an anti-mouse TNF-a antibody (Sb-amTNF) and proof-of-concept data demonstrating
that oral Sb-amTNF significantly ameliorated dextran sodium sulfate and bacterial colitis in mice. In this Fast-
track SBIR, we will pursue the Specific Aim 1 in Phase I study to perform biochemical and genetic
characterization of FZ006. In Phase II studies, Aim 2 will investigate pharmacokinetic and safety profiles of
FZ006, and Aim 3 will perform IND-enabling preclinical efficacy evaluation of FZ006 in human TNF-a
transgenic mice. All proposed activities will be guided by an exceptional advisory/consultant team with
specialized expertise in business development, biologics regulation, product development and planning, and
clinical development. Upon the completion of the proposed studies, we will pursue Phase IIb for generating
GMP product of FZ006, GLP toxicology and IND submission. Our long-term goal is to develop a novel oral
yeast immunotherapy against UC, a chronic intestinal disorder that causes tremendous morbidity and financial
losses in the US and worldwide.

## Key facts

- **NIH application ID:** 10399167
- **Project number:** 4R44DK129133-02
- **Recipient organization:** FZATA, INC.
- **Principal Investigator:** Zhiyong Yang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $855,001
- **Award type:** 4N
- **Project period:** 2022-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10399167

## Citation

> US National Institutes of Health, RePORTER application 10399167, Novel Oral Yeast Immunotherapies for Ulcerative Colitis (Fast-track) (4R44DK129133-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10399167. Licensed CC0.

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