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- 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 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.
- 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.
- INmune Bio has partnered with Cell and Gene Therapy Catapult to establish commercial-scale manufacturing for CORDStrom, a promising therapy for recessive dystrophic epidermolysis bullosa that showed positive results in Phase 2 trials. - The collaboration leverages CGT Catapult's Stevenage Manufacturing Innovation Centre to scale production for approximately 4,000 children with intermediate to severe RDEB across the US, UK, and EU. - Following CORDStrom, INmune Bio plans to transition production of INKmune, its NK-priming cell medicine currently in Phase 2 trials for metastatic castration-resistant prostate cancer.
- INmune Bio presented baseline demographics from its MINDFuL Phase II trial showing 208 patients with early Alzheimer's disease and confirmed biomarkers of inflammation, with 69.2% being APOE ε4 carriers. - The trial is evaluating XPro™, a dominant-negative TNF inhibitor administered weekly at 1.0 mg/kg, with cognitive function measured by the Early and Mild Alzheimer's Cognitive Composite (EMACC) as the primary endpoint. - Patient characteristics closely resemble those in successful Phase III Alzheimer's trials, with 44% diagnosed with MCI and 56% with mild AD, suggesting strong translational potential when topline results are released in June 2025.
