# Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer

> **NIH NIH R44** · A AND G PHARMACEUTICAL, INC. · 2020 · $1,062,115

## Abstract

In 2017, ~200,000 new cases of breast cancer (BC) and ~40,000 related deaths are expected in the US. ~30,000
of these are patients with aggressive triple negative BC (TNBC) or anti-estrogen/aromatase inhibitor resistant
(AE/AI) BC that do not have targeted therapy and rely on radiotherapy and aggressive chemotherapy. A new
approach that benefits these patients and provides increased life expectancy needs to be developed. We have
identified GP88, a glycoprotein that is produced by cancer cells and stimulates their growth and survival leading
to formation of more aggressive tumors. GP88 is found in BC but not in normal breast tissue. There is compelling
biological and clinical evidence to suggest that GP88 can be used to develop novel targeted therapy with
companion diagnostics that could impact treatment and improve survival of TNBC and AE/AI BC patients. We
have developed a tissue test to identify patients with tumors expressing GP88 and an anti-GP88 (AG1) to block
the action of GP88 on tumor tissues to a) inhibit tumor growth and b) increase the efficacy of current BC drugs.
We have safety and efficacy data in animals and will in our Phase 1 develop a dosing strategy in mice before
moving into human studies as part of the Phase 2. Additionally, a blood test has been developed to monitor
patients while on treatment. Using AG1 as the therapy with two companion diagnostic tests, we will carry out a
phase IA/B clinical trial in humans to determine safety of AG1 manufactured under GMP in the Phase 2 and will
collect tumor tissue and blood on all patients to evaluate for GP88 expression (tissue) and concentration (blood).

## Key facts

- **NIH application ID:** 10245772
- **Project number:** 4R44CA224718-02
- **Recipient organization:** A AND G PHARMACEUTICAL, INC.
- **Principal Investigator:** Ginette Serrero
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,062,115
- **Award type:** 4N
- **Project period:** 2018-09-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10245772

## Citation

> US National Institutes of Health, RePORTER application 10245772, Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer (4R44CA224718-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10245772. Licensed CC0.

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