On April 11, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported data demonstrate that INmune Bio’s INB03 reverses MUC4 experssion in HER2+ BC cell line (JIMIT-1) to re-establish sensitivity to trastuzumab (traz) and tyrosine kinase inhibitors (TKI) (Press release, INmune Bio, APR 11, 2022, View Source [SID1234611957]). Mucin 4 (MUC4), a glycoprotein is an easily measured biomarker in women with breast cancer. Previously, INmune Bio reported MUC4 expression predicts worse survival in women with HER2+ BC (p≤0.04). Study results show this new evaluation focused on the effects of MUC4 expression on the immune cells of the tumor microenvironment (TME) in HER2+ BC. These data were presented here today at the American Association of Cancer Research Annual Meeting in 2022, held in New Orleans April 8-13.
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The findings of this study predict that women with MUC4+/HER2+ BC are expected to have fewer tumor infiltrating lymphocytes (TILs) than women who do not express MUC4 (p=0.018). In a nude mouse model of MUC4+HER2+ BC, the combination of INB03+traz increased the number of activated NK cells (p=0.01) and anti-tumor macrophages (p=0.01) in the TME. In this nude mouse model, anti-tumor macrophage function is more important than NK cell function in controlling tumor growth.
"We have previously shown that MUC4 expression correlates with resistance to traz and TKI," said lead investigator Dr. Roxana Schillaci of Instituto de Biología y Medicina Experimental in Buenos Aires. "We can add third resistance mechanism to the list – an immunologically "cold" TME. These three resistance mechanisms are driven by soluble TNF produced by the tumor and are reversed by INB03 in the animal models."
"Resistance to immunotherapy occurs in about a third of women with HER2+ BC," said RJ Tesi MD, CEO of INmune Bio. "MUC4 is a biomarker of resistance that can be determined from the patient’s biopsy. Identifying a modifiable resistance factor early may allow the clinical team to optimized immunotherapy to improve outcome."
The poster will be presented by Dr. Roxana Schillaci on April 11. Details of the poster are as follows:
Title: MUC4 enables tumor immune evasion in HER2+ breast cancer
Poster: #2085 in Immune Response to Therapy 1
About INB03
INB03 is a DN-TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting trans membrane TNF (tmTNF). Compared to currently available non-selective TNF inhibitors, INB03 preserves the immune response to cancer by decreasing immunosuppressive cells in the TME including TAM and MDSC while promoting recruitment of anti-tumor immune cells including cytolytic CD8+ lymphocytes, NK cells and anti-tumor macrophages. INB03 has completed a open label dose-escalation Phase I trial in patients with advanced cancer. In that trial, INB03 was found to be safe and well tolerated – no dose limiting toxicity was found. INB03 decreased blood biomarkers of inflammation in patients with advanced cancer. INMB is planning a Phase II trial that uses IN03 as part of combination therapy.