INmune Bio Advances XPro1595 and CORDStrom Regulatory Programs

INmune Bio Inc., a clinical-stage biotechnology company, announced it has reached alignment with the FDA on core elements of its Phase III registration program for XPro1595 in Alzheimer's disease following an end of Phase II meeting. On February 12, 2026, the company received official minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration.

XPro1595 is a first-in-class selective soluble TNF inhibitor that works by blocking the form of TNF that drives pathology while preserving the form that supports normal immune function. The XPro1595 trial will use CDR-SB as sole primary endpoint, supporting precision medicine. The FDA supports biomarker-driven enrichment strategy for the Alzheimer's trial.

The MINDFuL trial was a short, small enriched population study in Alzheimer's disease designed to answer two specific questions: Does XPro show biologic activity in patients with AD and biomarkers of inflammation, and can the company identify the right patient population for a registration trial. The trial was designed to solve for two critical variables, biologic signal and patient selection.

On February 10, 2026, INmune Bio submitted a pre-submission package to the U.K. Medicines and Healthcare Products Regulatory Agency for CORDStrom, a potential first systemic therapy for recessive dystrophic epidermolysis bullosa, following encouraging safety and efficacy data from its MissionEB trial and successful commercial-scale manufacturing runs in Stevenage. CORDStrom aims to be the first systemic therapy for RDEB, targeting mid-2026 MAA filing.

The company holds U.S. Orphan Drug and Rare Pediatric Disease designations for CORDStrom. Recent U.S. legislation extending the FDA's Rare Pediatric Disease Priority Review Voucher program to 2029 could enhance the economic and regulatory incentives around eventual approval, as the company prepares for a U.S. biologics license application and broader regulatory filings later in 2026.

INmune Bio Inc. is a publicly traded, clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Its three product platforms are CORDStrom, an allogeneic human umbilical cord-derived mesenchymal stromal cell therapy platform; XPro, a DN-TNF biologic targeting inflammatory pathways; and INKmune, a cell-based therapy designed to enhance natural killer cell activity in cancer.