On December 11, 2018 INmune Bio, Inc., an immunotherapy company developing treatments to reprogram the innate immune system, reported that its lead drug candidate for treatment-resistant cancers, INB03, successfully inhibited the proliferation of tumor growth in pre-clinical models of trastuzumab treatment-resistant breast cancer (Press release, INmune Bio, DEC 11, 2018, View Source [SID1234531998]). The study was conducted by Roxana Schillaci, PhD., Researcher at the Institute of Biology and Experimental Medicine (IBYME-CONICET). Dr. Schillaci presented the data during a poster presentation at the San Antonio Breast Cancer Symposium in San Antonio, Texas, on December 8th.
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In the United States, one out of eight women will develop invasive ductal carcinoma (IDC) breast cancer in their lifetime. Two of those eight will have human epidermal growth factor receptor 2 (HER2) positive breast cancer that is treated with trastuzumab, an immunotherapy targeting HER2. Primary or secondary treatment resistance is a significant clinical problem that occurs in up to half of patients receiving trastuzumab for treatment of their HER2 positive breast cancer.
"Today, the definition of trastuzumab resistant breast cancer is the progression of breast cancer while the patient is on trastuzumab therapy," said Dr. Schillaci. "Our work shows that mucin 4 (MUC4) proteins, that block trastuzumab from binding with HER2 receptors, can be used as a biomarker to predict treatment-resistance. Additionally, the data shows that trastuzumab resistance can be reversed by eliminating soluble tumor necrosis factor (sTNF) in the tumor microenvironment".
Dr. Schillaci’s work showed that expression of MUC4 protein on cancer cells predicts trastuzumab resistance. The expression of MUC4 is caused by sTNF. Dr. Schillaci used INB03 to inhibit sTNF in mice to decrease MUC4 expression and reverse trastuzumab resistance. In further work, Dr. Schillaci’s team demonstrated that women resistant to trastuzumab express MUC4 on tumor while patients sensitive to trastuzumab do not.
"The results of this study suggest a possible solution for an ongoing problem in the treatment of women with HER2 positive breast cancer – predicting and treating trastuzumab resistance", said RJ Tesi, M.D., CEO and Co-Founder of INmune Bio. "If this work is confirmed in the clinic, the addition of therapy targeting sTNF, such as INB03, may improve the treatment options for a group of women previously unable to benefit from immunotherapy with trastuzumab."
INmune Bio initiated a Phase I clinical trial of INB03 on May 23. The company’s other drug candidate, INKmune, will enter clinical trials in early 2019.