Drugs / PEGIPANERMIN
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | Alzheimer disease | 2022-05-20 | “FDA review of Chemistry Manufacturing and Controls (CMC) associated with a recently placed clinical hold on XPro1595 AD trials is ongoing.” inmunebio.com ↗ “The Company received notification by the FDA that the US Phase II trial remains on full clinical hold” inmunebio.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03943264 | Nov 2019 → Jun 2021 | Alzheimer disease | Inmune Bio, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05321498 | Jun → Oct 2023 | Alzheimer disease, mental disorder | Inmune Bio, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05522387 | Feb 2023 → Jun 2024 | Alzheimer disease, mental disorder | Inmune Bio, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05318976 | Feb 2022 → May 2025 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia, mental disorder | Inmune Bio, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04370236 | Oct 2020 → Oct 2021 | COVID-19 | Inmune Bio, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 51
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Inmune Bio, Inc. | Results INmune Bio’s XPro1595 Prevents Brain-Injury-Induced Alzheimer's Pathology, Memory Loss, and Pain in New Peer-Reviewed Preclinical Study inmunebio.com ↗
The study points to soluble TNF as a key biological link between head injury and Alzheimer’s disease and shows that selectively neutralizing it with XPro1595 prevents the injury-induced rise in amyloid pathology while improving early cognitive and pain-related outcomes. |
| 2026-07-09 | Inmune Bio, Inc. | Results INmune Bio to Present Positive Phase 2 Imaging Data for XPro in Early Alzheimer’s Disease at AAIC inmunebio.com ↗
Advanced MRI analyses showed early treatment-related changes in white matter myelin integrity and cortical microstructure at Week 24, supporting biologic activity of selective soluble TNF inhibition. |
| 2026-06-02 | Inmune Bio, Inc. | Results INmune Bio Reports Statistically Significant Treatment Effect on Advanced White Matter MRI Biomarker in Phase 2 MINDFuL Alzheimer's Trial inmunebio.com ↗
XPro1595 showed a highly significant treatment effect in the full mITT population (p=0.0028; d=0.46; n=200), demonstrating broad tissue-level target engagement and treatment-related biological effect. |
| 2026-05-15 | Inmune Bio, Inc. | Results INmune Bio Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro™ Platform inmunebio.com ↗
In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed. |
| 2026-05-14 | Inmune Bio, Inc. | Regulatory INmune Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer's Disease inmunebio.com ↗ |
| 2026-04-16 | Inmune Bio, Inc. | Results INmune Bio Inc. Announces New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models inmunebio.com ↗
Notably, it further enhanced tucatinib’s effect on lung metastases (p < 0.05 to p < 0.0001). |
| 2026-03-19 | Inmune Bio, Inc. | Results INmune Bio’s MINDFuL Trial Featured at AD/PD 2026 Plenary as Successful Example of How to Approach Clinical Trials Targeting Inflammation in Early Alzheimer’s Disease inmunebio.com ↗
The biomarker enrichment strategy in MINDFuL is exactly the kind of precision approach that changed the trajectory of cancer treatment. |
| 2026-02-12 | Inmune Bio, Inc. | Regulatory INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease inmunebio.com ↗
The minutes confirm regulatory alignment on the Company’s proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer’s Disease (AD). |
| 2025-12-01 | Inmune Bio, Inc. | Results INmune Bio Reports New Phase 2 Grey Matter Imaging Data at CTAD Conference Reinforcing XPro1595’s Evidence Base in High-Inflammation Alzheimer's Patients inmunebio.com ↗ |
| 2025-09-29 | Inmune Bio, Inc. | Results INmune Bio Announces Submission of Phase 2 MINDFuL Trial Results in Alzheimer’s Disease to npj Dementia, a Nature Portfolio Journal inmunebio.com ↗
Boca Raton, FL, Sept. 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. |
| 2025-06-30 | Inmune Bio, Inc. | Results INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer’s Disease inmunebio.com ↗
INmune Bio Inc. (NASDAQ: INMB), today announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro™, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. |
| 2025-06-10 | Inmune Bio, Inc. | Results XPro™ Reduces Amyloid and Enhances Behavior Post Traumatic Brain Injury in an Animal Model of Alzheimer’s Disease: Supported by Department of Defense inmunebio.com ↗
The poster demonstrates that Traumatic Brain Injury (TBI) increases amyloid deposition in high-risk animals and that administration of XPro™ (XPro1595, pegipanermin ) significantly reduces amyloid formation and improves clinical measures of brain function. |
| 2025-04-01 | Inmune Bio, Inc. | Results INmune Bio Inc. Presents Baseline Demographics and Disease Profiles of Participants in the MINDFuL Phase II Study inmunebio.com ↗ |
| 2024-10-24 | Inmune Bio, Inc. | Results INmune Bio Inc. Announces Publication in Cell Reports Demonstrating XPro™ Promotes Remyelination inmunebio.com ↗ |
| 2024-07-29 | Inmune Bio, Inc. | Results INmune Bio Inc. Announces New Phase 1 Study Data Demonstrating Dose-Dependent Effect of XPro™ on Proteins that Regulation Synapses in Alzheimer’s Patients inmunebio.com ↗
The new analysis revealed that a 12-week treatment with XPro™ resulted in a significant change in synaptic proteins, which are essential for communication between neurons. |
| 2024-04-30 | Inmune Bio, Inc. | Results INmune Bio Inc. Provides Update on Two Patients from the Phase 1b Alzheimer’s Disease Trial who Continue to Receive XPro™ Under Compassionate Use for Over Three Years inmunebio.com ↗
Reports from the primary care physicians indicate that XPro™ has been well-tolerated throughout the treatment period, with stable cognitive function observed in the patients. |
| 2024-04-08 | Inmune Bio, Inc. | Results INmune Bio Inc. Presents Data on INB03’s Role as an Immune Check Point Modulator in the Treatment of High-Risk Breast Cancer at AACR 2024 inmunebio.com ↗
The two posters will be presented at the annual American Association of Cancer Research in San Diego on April 8, 2024. |
| 2024-03-05 | Inmune Bio, Inc. | Results INmune Bio Reports Significant EEG Improvement in Alzheimer’s Patients Treated with XPro™ inmunebio.com ↗
Patients with Alzheimer’s Disease show improvement in brainwaves following 4 weeks of XPro™ therapy. |
| 2024-02-06 | Inmune Bio, Inc. | Results INmune Bio to Participate in Baird’s Biotech Discovery Series Webcast on February 13, 2024 inmunebio.com ↗ |
| 2023-12-18 | Inmune Bio, Inc. | Regulatory INmune Bio Provides Update Regarding Global Alzheimer’s Phase II Clinical Trial and Clinical Hold Issued by the United States FDA inmunebio.com ↗
The Company received notification by the FDA that the US Phase II trial remains on full clinical hold pending a request for additional information on long-term potency. |
| 2023-11-29 | Inmune Bio, Inc. | Results INmune Bio Inc. Demonstrates that INB03 Enhances the Uptake of Trastuzumab Deruxtecan in HER2+ Breast Cancer with MUC4 Expression in Poster Presented at San Antonio Breast Cancer Symposium inmunebio.com ↗
INB03 increases uptake of deruxtecan, the immunotoxin associated with trastuzumab deruxtecan (T-DXd, ENHERTU®), in models of resistant MUC4 expressing HER2 positive breast cancer and increases the tumor killing immunology of the tumor microenvironment. |
| 2023-11-27 | Inmune Bio, Inc. | Regulatory INmune Bio Receives EMA’s Authorization in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer’s Disease inmunebio.com ↗ |
| 2023-11-15 | Inmune Bio, Inc. | Regulatory INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in Europe inmunebio.com ↗ |
| 2023-10-30 | Inmune Bio, Inc. | Results INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα inmunebio.com ↗
The poster entitled “ INB03: a new immune checkpoint inhibitor that reprograms polarization and promotes ADCP in human macrophages,” shows that INB03 is an innate immune checkpoint inhibitor working through the SIRPα-CD47 pathway to promote ADCP. |
| 2023-10-17 | Inmune Bio, Inc. | Results INmune Bio Inc. Presents New Biomarker and Feasibility Data from Phase 1b Study Supporting the Use of XPro™ to Treat Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference inmunebio.com ↗
Treatment with XPro™ was associated with dose-dependent improvement in neurology-related proteins that are the most strongly associated with the core AD pathologies of amyloid-beta (Aβ) and phosphorylated tau (pTau), in this sample. |
| 2023-09-05 | Inmune Bio, Inc. | Regulatory INmune Bio Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Phase 2 Clinical Trial in Alzheimer’s Disease inmunebio.com ↗
today received authorization of its Clinical Trial Application (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2 trial in Early Alzheimer’s disease (AD) with XPro™. |
| 2023-07-11 | Inmune Bio, Inc. | Results INmune Bio Inc. Announces Novel MRI Biomarker Data Demonstrating Improvement in Gray Matter in Patients with Alzheimer’s Disease inmunebio.com ↗
Analysis of MRI scans in participants from an open label Phase 1b study demonstrates that CDM ® , a novel gray matter biomarker, is improved following three months of treatment with XPro1595 TM |
| 2023-07-10 | Inmune Bio, Inc. | Results INmune Bio Inc. Announces Data Presented at the 16th European Meeting on Glial Cells in Health and Disease Shows that XPro™ Promotes Remyelination by Affecting Astroglial and Microglial Biology inmunebio.com ↗
Neutralizing soluble TNF with XPro™ promotes remyelination in cuprizone model after increasing astrocyte and microglia activation responses |
| 2023-04-19 | Inmune Bio, Inc. | Results XPro1595 Improves Outcomes in a Mouse Model of TBI-induced Alzheimer’s Disease inmunebio.com ↗
Treatment with XPro™ one hour after TBI prevents the development of amyloid pathology in the brain. |
| 2023-04-11 | Inmune Bio, Inc. | Results INmune Bio, Inc. to Present Preclinical Data at the 2023 AACR Annual Meeting Showing Improved Outcomes in High-Risk Breast Cancer by Targeting MUC4 Expression with INB03 inmunebio.com ↗
Two presentations show targeting high-risk MUC4 expressing HER2+ and Triple Negative Breast Cancer with INB03 reverses resistance mechanisms to immunotherapy |
| 2022-12-06 | Inmune Bio, Inc. | Results INmune Bio, Inc. Reports Combination Therapy with INB03™ Overcomes Resistance to Trastuzumab-Deruxtecan in MUC4 expressing HER2+ Breast Cancer inmunebio.com ↗
Neutralizing soluble TNF with INB03™ overcomes resistance to trastuzumab-deruxtecan in MUC4 expressing HER2+breast cancer. |
| 2022-11-14 | Inmune Bio, Inc. | Regulatory INmune Bio, Inc. Receives Health Canada “No Objection Letter” to Commence Clinical Trial of XPro1595 in Mild Alzheimer’s Disease inmunebio.com ↗
today announces that Health Canada has issued the Company a “No Objection Letter” to proceed with the Company’s trial using XPro1595 to treat mild Alzheimer’s Disease (AD) in Canada. |
| 2022-06-16 | Inmune Bio, Inc. | Results INmune Bio, Inc. Presents Data on Combination Therapy with INB03™ on Overcoming Resistance to HER2 Targeted Therapies in Breast Cancer inmunebio.com ↗
In pre-clinical models of trastuzumab resistant MUC4 HER2+ breast cancer, treatment with INB03™ decreases MUC4 expression, reverses resistance to trastuzumab based therapies, and promotes an immunologically active TME. |
| 2022-05-23 | Inmune Bio, Inc. | Regulatory INmune Bio, Inc. to Provide Additional Manufacturing Information to FDA as Part of IND Application for XPro1595™ in Alzheimer’s Disease inmunebio.com ↗
As part of the communication, the Agency placed the Company’s Investigational New Drug (IND) application to initiate its Phase 2 clinical trial of XPro™ in patients with Alzheimer’s Disease (AD) in the U.S. on clinical hold. |
| 2022-05-10 | Inmune Bio, Inc. | Results INmune Bio, Inc. Presents Data Demonstrating XPro™ Promotes Remyelination in Gray Matter at 3rd European Conference on Neuroinflammation inmunebio.com ↗
XPro™ Promotes Remyelination in a Cuprizone Model of Multiple Sclerosis(MS) by Improving Macrophage Phagocytosis (clearing) of Myelin Debris |
| 2022-04-11 | Inmune Bio, Inc. | Results INmune Bio, Inc. to Present Preclinical Data on INB03 at the American Association for Cancer Research (AACR) Annual Meeting 2022 inmunebio.com ↗
The findings of this study predict that women with MUC4+/HER2+ BC are expected to have fewer tumor infiltrating lymphocytes (TILs) than women who do not express MUC4 (p=0.018). |
| 2021-12-09 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Key Breast Cancer Treatment Resistance Data to be Presented at the 2021 San Antonio Breast Cancer Symposium inmunebio.com ↗
INB03, a DN-TNF therapy, can reverse TNBC treatment resistance by decreasing expression of MUC4 and reducing immunosuppression in the tumor microenvironment (TME) by increasing anti-tumor macrophage phagocytosis and increasing lymphocyte function in the TME. |
| 2021-09-01 | Inmune Bio, Inc. | Results Alzheimer’s Patients Treated with INmune Bio’s XPro™ Show Reduction in CSF Phospho-Tau and Evidence of Remyelination inmunebio.com ↗
XPro™ treatment shows statistically significant decrease in Phospho Tau 217 (pT271) and pT181, and an improvement in an imaging biomarker of myelination. |
| 2021-07-26 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Design of Upcoming Phase 2 Alzheimer’s Disease Clinical Trial and New Phase 1b AD Biomarker Data inmunebio.com ↗
The announcement is accompanied by the release of additional biomarker data from the Phase 1b AD trial that shows improvement in white matter (myelinated axons) that degenerate in AD patients. |
| 2021-01-21 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces XPro1595 Found to Decrease Neuroinflammation and Neurodegeneration Biomarkers in Patients with Alzheimer’s Disease in Phase 1b Trial inmunebio.com ↗
The data suggest that decreasing neuroinflammation results in significant improvements in biomarkers of neurodegeneration and synaptic function. |
| 2020-10-05 | Inmune Bio, Inc. | Results INmune Bio, Inc. Presents Preliminary Phase I Data at 21st International Conference on Alzheimer’s Drug Discovery inmunebio.com ↗
The preliminary data, albeit in a small number of patients, demonstrate that XPro1595, when given via subcutaneous injection, decreases neuroinflammation in the arcuate fasciculus, a white matter tract critical for the proper use of language. |
| 2020-07-13 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Interim Phase Ib Data Demonstrating That XPro1595 Decreases Neuroinflammation in Patients with Alzheimer’s Disease inmunebio.com ↗
Interim results from a Phase Ib clinical trial show that treatment with XPro1595 decreases white matter free water, a biomarker of neuroinflammation measured by MRI. |
| 2020-05-11 | Inmune Bio, Inc. | Results INmune Bio Inc’s INB03 Inhibits Cell Migration, Tumor Growth, and Induces Innate Immune Response in Pre-clinical Models of Trastuzumab-Resistant HER2+ Breast Cancer inmunebio.com ↗ |
| 2020-01-02 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Data on its Lead Compound Which Highlights The Potential to Lower The Risk of Alzheimer's Disease in Obese Individuals inmunebio.com ↗
These new data suggest that XPro1595 may have therapeutic potential to block various features of Alzheimer’s- like pathology in mice. |
| 2019-12-17 | Inmune Bio, Inc. | Results INmune Bio Announces Final Phase I Clinical Data for its Soluble TNF Inhibitor, INB03, Demonstrates Efficacy and Safety; INB03 is Advancing to Phase II Trials inmunebio.com ↗
Across all cancer subsets, INB03 showed no toxicities or serious adverse events and was well tolerated. |
| 2019-10-21 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Potentially Strong Link Between Obesity and Alzheimer's Disease at the Society for Neuroscience 49th Annual Meeting inmunebio.com ↗ |
| 2019-10-17 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Presentation of Data Related to its Lead Compound XPro1595 at the Society for Neuroscience’s Annual Meeting inmunebio.com ↗
The Company believes that XPro1595 is a next generation anti-inflammatory that crosses the blood-brain barrier to affect neurodegenerative diseases by selectively inhibiting soluble tumor necrosis factor. |
| 2019-08-05 | Inmune Bio, Inc. | Results INmune Bio Reports Positive Preliminary Data from INB03 Phase I Clinical Trial in Cancer inmunebio.com ↗
Today, positive preliminary data from the first two cohorts were released. |
| 2019-04-08 | Inmune Bio, Inc. | Results INmune Bio Announces Poster Presentation with New Data Regarding Neurodegenerative Disease Drug Candidate, XPro1595, at The European Conference on Neuroinflammation inmunebio.com ↗
Dr. Probert found that XPro1595 may promotes remyelination by increasing the presence of immune cells that remove damaged myelin. |
| 2018-12-11 | Inmune Bio, Inc. | Results Trastuzumab-Resistant HER2 Positive Breast Cancer Reversed By Treatment with INB03 inmunebio.com ↗
INmune Bio, Inc. , an immunotherapy company developing treatments to reprogram the innate immune system, today announced that its lead drug candidate for treatment-resistant cancers, INB03™, successfully inhibited the proliferation of tumor growth in pre-clinical models of trastuzumab treatment-resistant breast cancer. |
| 2018-11-15 | Inmune Bio, Inc. | Results Data from University of Pittsburgh on INB03TM for Treatment of Melanoma Presented at the 33rd Annual Society for Immunotherapy of Cancer (SITC) Meeting inmunebio.com ↗
The results of the research conducted at the University of Pittsburgh, demonstrated the potential effectiveness of INB03 TM , the company’s lead drug candidate in treatment of drug-resistant melanoma, which was developed from patented intellectual property licensed from the University of Pittsburgh. |
All press releases naming this drug 66 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PEGIPANERMIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | DN-TNF | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | INB03 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04370236 ↗ |
| Known as | Livnate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | Quellor | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | XENP-1595 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | Xpro | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802208 ↗ |
| Known as | XPro1595 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05522387 ↗ |
| Action | Inhibit | “second-generation inhibitor of tumor necrosis factor (TNF)” NCT03943264 ↗ |
| Modality | Protein / enzyme biologic | “the anti-TNF biologic XPro1595 used in our study.” PMID 22666474 ↗ May 2012 |
| Route | Subcutaneous | “XPro1595 will be delivered by subcutaneous injection once a week” NCT03943264 ↗ |
| Target | TNF | “XPro1595 is a second-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF” NCT03943264 ↗ |