INmune Bio, Inc. Is a clinical stage biotechnology company, which engages in developing new immunotherapies that reprograms the immune system to fight cancer and Alzheimer’s disease. Its products include pipeline, INKMUNE-Cancer, INB03-Cancer, XPRO1595-Alzheimer and TRD, and LIVNate. The company was founded by Mark Lowdell in September 2015 and is headquartered in Boca Raton, FL.
相关临床试验
7
2 进行中
药物批准
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监管机构
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监管机构数
成立时间
2015
进行中（未招募）
2
28.6%
已完成
2
28.6%
终止
2
28.6%
撤回
1
14.3%
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- INmune Bio announced that the FDA granted Fast Track designation to XPro1595 for treating early Alzheimer's disease, including mild cognitive impairment and mild dementia stages. - The designation aims to accelerate development and review processes due to the drug's potential to address neuroinflammation, a key factor in Alzheimer's progression. - XPro1595 selectively targets soluble TNF to reduce brain inflammation while preserving immune functions. - The company plans a Phase 2b/3 trial focusing on patients with biomarkers of inflammation to support regulatory approval.
- INmune Bio announced new preclinical data at AACR 2026 showing that INB03 (XPro1595) significantly enhances anti-tumor activity when combined with tyrosine kinase inhibitors in HER2-positive breast cancer models. - The combination therapy demonstrated statistically superior inhibition of cell proliferation and migration compared to TKIs alone, with p-values ranging from p < 0.05 to p < 0.0001. - INB03 significantly reduced metastatic spread to brain, lung, and liver organs, addressing a critical unmet need in advanced HER2-positive breast cancer treatment. - The mechanism involves selective soluble TNF neutralization that down-regulates MUC4, a protein that shields HER2 molecules from therapeutic binding.
