# Definitive (GLP) Toxicity and Toxicology Studies for a Novel Small Molecule for Protection Against Cardiotoxicity in Triple Negative Breast Cancer

> **NIH NIH SB1** · NOVOMEDIX, INC. · 2024 · $500,000

## Abstract

Abstract
 The overall goal of this program is the development and commercialization of a novel, safe, and effective,
therapy that synergizes with anthracyclines, such as Doxorubicin (DOX, Adriamycin), to maintain or improve
clinical outcome for the treatment of triple negative breast cancer (TNBC) as well as significantly decrease long-
term cardiotoxicity-related mortality caused by anthracycline treatment.
 Breast cancer is the most commonly diagnosed cancer in women worldwide and one of the leading causes
of cancer death among women in the U.S. More than 3.8 million women in the U.S. have a history of breast
cancer, which includes women currently being treated and women who have finished treatment. Over 43,000
women in the U.S. were estimated to die from breast cancer last year. Approximately 15% of all breast cancers
are categorized as TNBC due to the lack of expression of the estrogen receptor (ER), progesterone receptor
(PR), and human epidermal growth factor receptor type 2 (HER2). TNBC patients, therefore, do not respond to
hormonal breast cancer therapies or medicines that target HER2. Although new therapeutic options for TNBC
are emerging, systemic anthracycline chemotherapy, notably DOX, remains the standard of care for TNBC due
to its superior clinical efficacy. However, DOX and other anthracycline-based therapies result in dose-dependent,
progressive cardiomyopathy. The leading cause of mortality for breast cancer survivors is heart failure often
observed years after cessation of treatment. Breast cancer patients with preexisting heart disease or risk factors
for heart disease become especially prone to the delayed cardiotoxicity. The development of a therapy that
provides protection against DOX-induced cardiomyopathy and has synergistic anti-tumor activity in TNBC
patients would be highly significant.
 NovoMedix has developed safe, orally-available, small molecules that have dual activity acting as both
specific mTORC1 inhibitors and allosteric AMPK agonists. These novel compounds have demonstrated
cardioprotective and anti-cancer activity in multiple in vivo studies. NovoMedix, in collaboration with Dr. Salloum
and Dr. Das at Virginia Commonwealth University (VCU), has shown that an NM lead compound potentiates the
anti-tumor effect of DOX, while attenuating DOX-induced cardiotoxicity and left ventricular dysfunction, in a
TNBC mouse xenograft. We are also completing IND enabling studies which indicate that there are no significant
safety concerns.
 The specific aims for this project are: 1) develop and validate methods for analyzing API in dose formulations
and rat and dog plasma, 2) GLP toxicity and toxicology studies in rats, 3) GLP toxicity and toxicology studies in
dogs, and 4) submission and approval of an IND.

## Key facts

- **NIH application ID:** 10921449
- **Project number:** 1SB1HL174247-01
- **Recipient organization:** NOVOMEDIX, INC.
- **Principal Investigator:** Cathy A Swindlehurst
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $500,000
- **Award type:** 1
- **Project period:** 2024-09-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10921449

## Citation

> US National Institutes of Health, RePORTER application 10921449, Definitive (GLP) Toxicity and Toxicology Studies for a Novel Small Molecule for Protection Against Cardiotoxicity in Triple Negative Breast Cancer (1SB1HL174247-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10921449. Licensed CC0.

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