# A Novel Immunotherapy Targeting Cancer Stem Cells for the Treatment of Triple-Negative Breast Cancer

> **NIH NIH R44** · AGILVAX, INC. · 2020 · $1,152,921

## Abstract

Agilvax’s AX09 is an Immunotherapy for Triple-Negative Breast Cancer: Agilvax is developing cancer
immunotherapies and vaccines with its proprietary virus-like-particle (VLP) platform technology. Agilvax’s lead
product, AX09, is an immunotherapy for triple-negative breast cancer (TNBC) targeting cancer stem cells
(CSC) that is designed for use in combination with existing and emerging therapies. TNBC is extremely
aggressive with high rates of recurrence and overall poor outcomes as compared to other forms of breast
cancer. The average 5-year survival rate for metastatic patients with TNBC is only 26.1%. TNBC is more likely
to occur in women under the age of 40, and the rate of incidence is higher in African-American and Hispanic
populations as compared to Caucasian populations. It is estimated that 30,000 women will be diagnosed with
TNBC in 2017.
AX09 Targets Breast Cancer Stem Cells to Prevent Relapse and Metastasis: With no CSC targeted
therapies currently available, there is a critical need for the development of therapeutics for patients impacted
by TNBC. AX09 is composed of a VLP that displays a specific portion of a protein, xCT, that is overexpressed
in breast cancer stem cells (BCSC) and contributes to chemotherapeutic drug resistance and metastasis.
AX09 is favorably positioned in the emerging market of various treatment approaches targeting TNBC, which
will increasingly segment the patient population by novel biomarkers and molecular targets. Due to their
resistance to radiation and chemotherapies, BCSC represent a reservoir for the relapse, metastatic evolution
and progression after initial treatment. AX09 produces an oligoclonal antibody response against the BCSC
target, xCT, that will eliminate BCSC as a source of recurrence.
Agilvax’s Aims for the Fast-Track SBIR Include Preclinical Work, cGMP Manufacturing and a
Toxicology Study: Agilvax’s goals for this grant are to complete its preclinical work, including upstream and
downstream process development of AX09 based on processes the company successfully used in developing
another VLP-based product. As part of its first goal, Agilvax will strengthen AX09 efficacy by determining the
optimal dosage regimen, confirming efficacy in a second tumor model, and assess the combination of AX09
with other chemotherapeutic agents in planning for the Phase I trial design. Agilvax will proceed with cGMP
production and validation of research and master cell banks in order to complete cGMP manufacturing and
release testing of AX09 drug substance and drug product. Upon the recommendation of Agilvax’s Key Opinion
Leaders in breast cancer, a single nonclinical toxicology study using New Zealand white rabbits is planned.

## Key facts

- **NIH application ID:** 9934162
- **Project number:** 5R44CA224835-03
- **Recipient organization:** AGILVAX, INC.
- **Principal Investigator:** Joseph Patti
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,152,921
- **Award type:** 5
- **Project period:** 2018-08-01 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9934162

## Citation

> US National Institutes of Health, RePORTER application 9934162, A Novel Immunotherapy Targeting Cancer Stem Cells for the Treatment of Triple-Negative Breast Cancer (5R44CA224835-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9934162. Licensed CC0.

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