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.
Clinical Trials
9
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2015
Active, not recruiting
2
22.2%
Completed
2
22.2%
Recruiting
2
22.2%
Terminated
2
22.2%
Withdrawn
1
11.1%
No approval data available
- INmune Bio received MHRA approval of its Pediatric Investigation Plan for Ebstrocel, an investigational cell therapy for recessive dystrophic epidermolysis bullosa, in under three months following an accelerated review. - The MHRA's written alignment from a May 2026 Scientific Advice meeting validates the CMC, non-clinical, and clinical evidence packages, providing a clear roadmap toward a planned 2026 UK Conditional Marketing Authorization submission. - The agency recognized MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularly in pain and pruritus, and indicated the data could support positioning Ebstrocel as a chronic or intermittent supportive therapy for RDEB. - Approximately 300 children in the UK are affected by RDEB, part of a broader epidermolysis bullosa community of at least 5,000 individuals, underscoring the critical unmet need this therapy aims to address.
- 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 has successfully completed the first commercial-ready umbilical cord tissue processing at the CGT Catapult Manufacturing Innovation Centre in Stevenage, UK, under its agreement with Anthony Nolan Cord Blood Bank. - The manufacturing milestone supports a planned Phase 3 confirmation trial for Ebstrocel™ and future commercial supply, with processes now meeting MHRA, EMA, and FDA standards. - The company's regulatory strategy aligns with the MHRA's draft rare disease therapies regulatory framework, which emphasizes flexible evidence generation and patient-centered outcomes. - With commercial manufacturing, pediatric strategy, and regulatory alignment completed, INmune Bio believes Ebstrocel™ has entered the final stage before planned UK commercialization.
- 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.
- A peer-reviewed study in Cytotherapy journal highlights the therapeutic potential of mesenchymal stromal cell therapies, featuring INmune Bio's CORDStrom platform as a key example. - INmune Bio's lead scientist Dr. Nikita M. Patel served as one of the lead authors for the invitation-only working party publication examining MSC therapy development. - The company expects to file BLA and MAA applications for CORDStrom in recessive dystrophic epidermolysis bullosa by 2026. - CORDStrom represents an off-the-shelf, allogeneic cell therapy platform designed for inflammatory, degenerative, and autoimmune diseases.
- INmune Bio submitted CORDStrom pre-submission package to UK MHRA for recessive dystrophic epidermolysis bullosa treatment, targeting mid-2026 MAA filing as the first systemic therapy for this rare disease. - The company received FDA alignment on Phase 2b/3 pathway for XPro1595 in Alzheimer's disease, with the trial using CDR-SB as sole primary endpoint and biomarker-driven enrichment strategy. - Recent neuroimaging results from the Phase 2 MINDFuL trial showed XPro1595 slowed disease progression in early Alzheimer's patients with elevated neuroinflammation, supporting its potential as a first-in-class therapy.
- INmune Bio successfully completed its first commercial pilot-scale manufacturing run of CORDStrom™, an umbilical cord-derived mesenchymal stromal cell therapy for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). - The manufacturing milestone at the Cell and Gene Therapy Catapult facility in the UK keeps the company on track for regulatory submissions, with plans to file a Marketing Authorization Application in the UK during the first half of 2026. - CORDStrom™ demonstrated promising results in a blinded-randomized Phase 2 Mission EB trial, showing improvements in itch, pain, wound scores, and quality of life for RDEB patients. - The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production using a proprietary GMP-compliant process for this off-the-shelf allogeneic therapy.
- INmune Bio's phase 1/2 CaRe PC trial of INKmune therapy in metastatic castration-resistant prostate cancer has successfully met both primary and secondary endpoints, demonstrating favorable safety and tolerability across all three dose levels. - The NK cell-priming therapy showed greatest biomarker improvements in patients with low baseline NK cell activation, helping define the target population for future trials. - Individual tumor lesions were observed reducing in size or completely disappearing in some patients during treatment, suggesting direct anti-tumor effects. - The company plans to advance to a randomized phase 2b trial in patients with less severe disease to enable more robust measurement of clinical benefits.
- INmune Bio completed a $19 million registered direct offering on June 27, 2025, extending its operational runway through 2026 to support its lead Alzheimer's therapy XPro™. - The company's Phase 2 MINDFuL trial for XPro™, targeting neuroinflammation in early Alzheimer's disease, is expected to report top-line results by June 30, 2025. - XPro™ represents a differentiated approach by selectively neutralizing soluble TNF-alpha to reduce brain inflammation, unlike existing amyloid-focused therapies. - The stock surged 75% in after-hours trading following announcement of the June 30 results date, with analysts setting price targets of $30 representing 400% upside potential.
- INmune Bio's XPro™ (XPro1595, pegipanermin) significantly reduced amyloid formation and improved brain function in transgenic mice following traumatic brain injury. - The study demonstrated that XPro™ treatment administered 30 minutes post-injury prevented elevations in key Alzheimer's disease markers including TNFR1, BACE1, and Aβ42 levels. - Research findings support XPro™ as a promising therapeutic approach to reduce Alzheimer's disease pathology risk in patients who experience traumatic brain injury. - The drug works by selectively neutralizing soluble TNF without affecting transmembrane TNF or TNF receptors, targeting neuroinflammation linked to neurodegeneration.
