# Clinical Development of First-in-Class Therapy for Metastatic Breast Cancer

> **NIH NIH R44** · TRANSCODE THERAPEUTICS, INC. · 2022 · $1,129,316

## Abstract

We have developed a new therapeutic approach that relies on specific eradication of metastatic
tumor cells through pharmacological inhibition of miRNA-10b. miR-10b is a master regulator of the
viability of metastatic tumor cells and has been thoroughly validated as a promising therapeutic target
in over 100 clinical studies across 18 metastatic cancer types. The approach relies on a therapeutic
agent that specifically inhibits microRNA-10b in metastatic cells. The therapeutic (termed MN-anti-
miR10b) consists of ultrasmall dextran-coated iron oxide nanoparticles (MN), conjugated to
antagomirs targeting miRNA-10b. In our preclinical studies, we found that the therapeutic is taken up
avidly by metastatic tumor cells in the lymph nodes, lungs, bone, and brain, following intravenous
injection. We demonstrated that the miR-10b inhibitory therapeutic could elicit durable regression of
lymph node and distant metastases in mouse models of breast cancer with no evidence of systemic
toxicity. Specifically, just four to six weekly treatments with MN-anti-miR10b in combination with low
dose chemotherapy led to complete regression of detectable metastases. Following elimination of
metastases, therapy was discontinued. No recurrence was observed for the natural life of the
animals. In this application, we propose to perform key translational experiments including IND-
enabling and IND-supported imaging studies that would assess the uptake of MN-anti-miR10b by
radiologically confirmed metastatic lesions in breast cancer patients, as a final step before entry into
phase I clinical trials.

## Key facts

- **NIH application ID:** 10596292
- **Project number:** 4R44CA257093-02
- **Recipient organization:** TRANSCODE THERAPEUTICS, INC.
- **Principal Investigator:** Zdravka O Medarova
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,129,316
- **Award type:** 4N
- **Project period:** 2021-04-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10596292

## Citation

> US National Institutes of Health, RePORTER application 10596292, Clinical Development of First-in-Class Therapy for Metastatic Breast Cancer (4R44CA257093-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10596292. Licensed CC0.

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