# Validation of a novel 3D culture platform for TNBC treatment selection

> **NIH NIH R01** · METHODIST HOSPITAL RESEARCH INSTITUTE · 2024 · $583,104

## Abstract

PROJECT SUMMARY
The goal of this academic [Houston Methodist Research Institute (HMRI) and MD Anderson Cancer
Center (MDACC)] and industrial (EMPIRI) collaborative project is to validate a novel, functional cancer
diagnostic assay for clinical translation to improve and personalize the care of triple-negative breast cancer
(TNBC) patients. The study will validate a novel 3D tumor tissue culture method (E-slices) invented by MPI
Kyuson Yun (HMRI) and licensed to EMPIRI, Inc., a biotech startup co-founded by Dr. Yun and Dave Gallup
(MPI). Together with Dr. Naoto Ueno (MPI, MDACC), a renowned physician-scientist specializing in TNBC
research and patient care, the team will validate the predictive accuracy of E-slices for individual TNBC patient
responses to recently approved chemoimmunotherapy for early TNBC patient care.
 The need for personalized medicine in oncology is widely accepted but translating this important concept
into clinical practice has been challenging. Currently, the dominant platform for precision medicine utilizes
genomics/sequencing-based assays to measure the expression and/or mutational profiles and then infer
responses to targeted therapies; however, this approach benefits <10% of patients with profiled tumors.
Recognizing the inherent limitations of these inference-based methods, functional assays (e.g., organoids, PDX
models) have been developed, but these approaches have numerous limitations including high cost and time
required to establish the models, low “take rates”, and destruction of the native tumor microenvironment (TME).
To overcome these challenges, EMPIRI developed a novel 3D ex vivo tumor culture method (E-slices)
that enables rapid, personalized drug sensitivity testing in intact patient tumor tissues. E-slices retain the
native TME and tissue architecture and are cultured in serum-free defined media, overcoming the limitations of
other approaches. In addition, E-slices can be generated from any solid tumor and used for testing responses to
chemotherapy, targeted therapy, and immunotherapy. Importantly, E-slice accuracy has been validated in a
clinical setting for metastatic colorectal cancer to accurately predict individual patient treatment responses and
detect inter-patient differences to the same treatments in 4-12 days, paving the way for near evidence-based
personalized treatment selections. The team will: (i) determine whether E-slices predict patient responses to
SOC NAC: doxorubicin (Adriamycin) plus cyclophosphamide) in a retrospective study, (ii) measure
chemoimmunotherapy (Pembrolizumab plus paclitaxel + carboplatin) responses in humanized PDX slices from
known responders and non-responders; and (ii) evaluate the clinical utility of E-slices in predicting TNBC patient
responses to newly approved standard of care chemoimmunotherapy in a prospective study. Successful
completion of this project will provide the necessary data to apply E-slices as the first functional cancer diagnostic
test specificall...

## Key facts

- **NIH application ID:** 10911923
- **Project number:** 5R01CA271682-03
- **Recipient organization:** METHODIST HOSPITAL RESEARCH INSTITUTE
- **Principal Investigator:** David Gallup
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $583,104
- **Award type:** 5
- **Project period:** 2022-09-20 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10911923

## Citation

> US National Institutes of Health, RePORTER application 10911923, Validation of a novel 3D culture platform for TNBC treatment selection (5R01CA271682-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10911923. Licensed CC0.

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