On December 17, 2019 INmune Bio, Inc., an immunology company developing therapies that reprogram the patient’s innate immune system to treat diseases, reported that it has successfully completed the Phase I trial of INB03 and the database has been locked (Press release, INmune Bio, DEC 17, 2019, View Source [SID1234552433]). The Phase I trial was an open-label, dose-escalation trial in patients with advanced solid tumors. "This was our first trial of the DN-TNF platform in patients, and we are pleased with the safety and efficacy results," said RJ Tesi, MD, CEO and CMO of INmune Bio. "This milestone now allows us to move the trial to Phase II in cancer and leverage our data into other programs for our DN-TNF platform."
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Key Findings:
●1 mg/kg was selected as the recommended Phase II dose for further studies.
●Across all cancer subsets, INB03 showed no toxicities or serious adverse events and was well tolerated.
●The inflammatory cytokine IL-6, a biomarker of soluble TNF function decreased by more than 50% in half the patients suggesting a pharmacodynamic effect of INB03.
The Phase II program will be targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy. The program is based on data presented at the San Antonio Breast Cancer Symposium in 2018 by Professor Roxana Schillaci. The data revealed that women with MUC4 expressing HER2+ breast cancers have worse survival than women who do not express MUC4. Furthermore, the data illustrated treatment with INB03 decreased MUC4 expression to make the HER2 expressing cancer sensitive to trastuzumab.
"Resistance to trastuzumab is common problem in women with HER2+ breast cancer," said RJ Tesi, MD, CEO and CMO of INmune Bio. "Current therapies attempt to treat the breast cancer without eliminating the resistance mechanism. In animal models, INB03, by neutralizing the soluble TNF that drives MUC4 expression, makes the resistant cancer cells sensitive to trastuzumab. We plan to confirm this observation in the Phase II clinical trial in women with metastatic HER2+ breast cancer."
Breast cancer is the most common cancer in women in the US with more than 268,000 new cases in 2019 according to the from the American Cancer Society. Because of the population growth and demographic changes, more than 400,000 new cases of breast cancer are expected in 2030. The breast cancer therapy market is expected to grow at more than 9% CAGR and will be valued in excess of $28 billion USD in 2024.