Overview
INmune Bio is a clinical-stage biotechnology company developing therapies that modulate the innate immune system for cancer and Alzheimer's disease. Key products include XPro1595 (DN-TNF platform) in Phase 2 for early Alzheimer's with inflammation biomarkers and cancer, and INKmune for metastatic castration-resistant prostate cancer. The company has multiple late-stage assets with upcoming regulatory milestones, including FDA interactions for Alzheimer's and rare diseases.
Frequently asked questions
- What are INmune Bio's main therapeutic platforms and pipeline?
- INmune Bio targets innate immune system components with DN-TNF platform (XPro1595 for Alzheimer's and cancer), INKmune for metastatic castration-resistant prostate cancer, and CORDStrom for recessive dystrophic epidermolysis bullosa. Multiple assets are in late-stage development with near-term regulatory milestones.
- What are the latest clinical trial results for XPro in Alzheimer's?
- In the Phase 2 MINDFuL trial, XPro showed cognitive (EMACC effect size 0.27), behavioral, and biomarker (pTau217) benefits in amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), despite missing primary endpoint in broader mITT population (n=200). Company plans FDA Breakthrough Therapy Designation and End-of-Phase 2 meeting.
- What is the regulatory and geographic status of INmune Bio's programs?
- Trials like CaRe Prostate (Phase I/II for INKmune) are US-based. Company intends FDA BLA submission for CORDStrom in RDEB, Breakthrough Designation for XPro in AD, and engagement with UK, EU regulators. Products like XPro are administered via weekly subcutaneous injection.