This section highlights FDA-related milestones and regulatory updates for drugs developed by INmune Bio (INMB).
Over the past two years, INmune Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AD02, CORDStrom, INB03, INKmune, XPro, and XPro1595. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AD02 - FDA Regulatory Timeline and Events
AD02 is a drug developed by INmune Bio for the following indication: For Alzheimer Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AD02
- Announced Date:
- September 30, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio announced that that it closed enrollment for its Phase 2 trial on Friday, 27 September.
AI Summary
INmune Bio announced a key milestone in its global, blinded, randomized Phase 2 clinical trial (AD02 trial) for early Alzheimer’s disease on September 27. The company closed enrollment after confirming that there were enough patients—meeting the target of 201—to continue the study. Patients with early Alzheimer’s and biomarkers of elevated neuroinflammation are part of this trial, which is designed to test the impact of XPro™, a potential treatment to reduce brain inflammation. All patients currently in the screening process will remain eligible, which may result in a modest number of extra participants. INmune Bio sees this accomplishment as an important step forward in improving the study’s power to evaluate treatment efficacy. The announcement highlights the dedication of the research team and participants in the ongoing efforts to develop better treatments for early Alzheimer's disease.
Read Announcement- Drug:
- AD02
- Announced Date:
- September 17, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio Inc. announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint for AD trials.
AI Summary
INmune Bio Inc. announced important findings from additional analysis of blinded data in its AD02 Phase II Alzheimer’s trial. The study showed that the novel cognitive measure EMACC performed exceptionally, demonstrating a highly significant correlation (p<0.001) with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint in AD trials. This strong relationship confirms that EMACC reliably tracks cognitive changes in early Alzheimer’s patients, providing a more objective measurement compared to the CDR-SB, which was initially designed for staging rather than detecting subtle cognitive shifts.
The results support the decision to use EMACC as the primary endpoint in the trial, indicating a more precise and replicable method for evaluating cognitive function. These promising findings may lead to improved clinical trial designs and a better understanding of treatment effects in Alzheimer’s disease.
Read Announcement- Drug:
- AD02
- Announced Date:
- June 27, 2024
- Indication:
- For Alzheimer Disease
Announcement
INmune Bio confirmed the Phase II Alzheimer's Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial's primary endpoint, the Early Mild Alzheimer's Cognitive Composite (EMACC).
AI Summary
INmune Bio confirmed that its Phase II Alzheimer’s Disease clinical trial, AD02, is appropriately powered after a blinded sample size re-estimation using the Early Mild Alzheimer’s Cognitive Composite (EMACC). A third-party team of statisticians and neuropsychologists reviewed the interim data from patients who completed the 6-month trial. Their evaluation showed that the performance of EMACC—an objective cognitive measure designed for early Alzheimer’s—is consistent with expectations, and no changes are needed in the trial’s design or size.
This careful review ensures that the trial is well-equipped to detect cognitive changes in early Alzheimer’s patients. The findings support the company’s robust, data-driven approach to tracking the effects of its treatment that targets neuroinflammation, reinforcing confidence in both the EMACC tool and the overall trial methodology.
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CORDStrom - FDA Regulatory Timeline and Events
CORDStrom is a drug developed by INmune Bio for the following indication: For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CORDStrom
- Announced Date:
- April 16, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio Inc announced a major intellectual property milestone with respect to its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™.
AI Summary
INmune Bio Inc. announced a significant intellectual property milestone for its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™. The company received a favorable written opinion from the USPTO on all claims in its international patent application PCT/US25/17028. This written opinion confirms that the claims meet the key international patent requirements of novelty, inventive step, and industrial applicability. CORDStrom™ uses pooled, culture-expanded human umbilical cord-derived MSCs, offering a promising, scalable, and consistent cell therapy option for treating a range of inflammatory and degenerative diseases. The milestone is a critical step towards securing long-term patent protection that could extend exclusivity on the technology through at least 2045. INmune Bio also plans to expedite the patent process in the U.S. via the Patent Prosecution Highway, further strengthening its intellectual property position.
Read Announcement- Drug:
- CORDStrom
- Announced Date:
- April 14, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio Inc. a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms.
AI Summary
INmune Bio Inc., a clinical-stage biotechnology company, has joined forces with the Cell and Gene Therapy Catapult to build a large-scale, commercial-ready manufacturing facility for its cell therapy platforms. This partnership will leverage the Catapult’s Stevenage Manufacturing Innovation Centre and INmune Bio’s existing setup at the Royal Free Hospital, aiming to boost the production of advanced therapies.
The initial focus is on increasing production of CORDStrom™, a promising cell therapy for treating recessive dystrophic epidermolysis bullosa (RDEB), a rare inherited skin disorder. By scaling up manufacturing, the collaboration is set to support ongoing clinical trials and prepare for future regulatory applications. This strategic move not only paves the way for broader clinical use of the therapy but also highlights the cross-border cooperation essential for advancing innovative treatments and strengthening the UK’s role in the advanced therapies industry.
Read Announcement- Drug:
- CORDStrom
- Announced Date:
- February 10, 2025
- Indication:
- For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Announcement
INmune Bio, announced today, following a Type C meeting with the U.S. Food and Drug Administration (FDA), its intent to submit a BLA in the US and Marketing Authorization Application (MAA) in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients.
AI Summary
INmune Bio announced plans to advance its investigational therapy, CORDStrom, following a Type C meeting with the FDA. The company intends to submit a Biologics License Application (BLA) in the US and a Marketing Authorization Application (MAA) in the UK and EU. These submissions will be supported by encouraging data from the MissionEB clinical trial, which evaluated CORDStrom as a disease-modifying treatment for pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The trial demonstrated a favorable benefit-risk profile and promising clinical effects in reducing symptoms such as itch and skin damage among children suffering from this severe genetic disorder. This regulatory effort marks a significant step towards addressing a large unmet need in treating RDEB, potentially improving the quality of life for affected young patients. Additional data may further strengthen the future approval process.
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INB03 - FDA Regulatory Timeline and Events
INB03 is a drug developed by INmune Bio for the following indication: INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB03
- Announced Date:
- April 8, 2024
- Indication:
- INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα
Announcement
INmune Bio, is presenting data on the use of INB03, a dominant-negative tumor necrosis factor (TNF) inhibitor of soluble TNF (sTNF) in the treatment of high-risk MUC4 expressing HER2+ and triple negative breast cancer (TNBC).
AI Summary
INmune Bio is presenting promising data on INB03, a new dominant-negative tumor necrosis factor (TNF) inhibitor that targets soluble TNF (sTNF) in high-risk breast cancers. The treatment focuses on MUC4 expressing HER2+ and triple negative breast cancers (TNBC), which are often resistant to current therapies.
In preclinical studies, INB03 helped decrease immune checkpoint proteins on T cells and macrophages while reducing tumor markers linked to invasion and metastasis. This approach not only enhances T cell infiltration into the tumor microenvironment but also reprograms macrophages to fight the tumor more effectively. The data suggest that using INB03 could improve treatment outcomes by overcoming immune evasion, leading to a more active anti-tumor immune response in these aggressive cancers.
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INKmune - FDA Regulatory Timeline and Events
INKmune is a drug developed by INmune Bio for the following indication: High-Risk Myelodysplastic Syndrome (MDS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INKmune
- Announced Date:
- February 12, 2025
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio Inc. pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort.
AI Summary
INmune Bio Inc. recently announced a significant milestone in its clinical trial for the INKmune™ natural killer (NK) cell therapy aimed at treating metastatic castration-resistant prostate cancer. The company has successfully completed the third and highest dose cohort in the Phase I portion of the trial. This achievement allowed the trial to progress into the Phase II high dose cohort, where researchers can further evaluate the benefits and therapeutic potential of the higher dosage levels.
The completion of this highest dose group indicates that the treatment has maintained a strong safety profile in earlier testing. By moving into Phase II, INmune Bio intends to explore whether increased doses can enhance the immunologic effects and improve patient outcomes. This step marks an important move toward developing an effective outpatient treatment for men battling advanced prostate cancer.
Read Announcement- Drug:
- INKmune
- Announced Date:
- September 26, 2024
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio Inc. announce initial results from the first patient cohort in the trial.
AI Summary
INmune Bio Inc. announced early results from the first patient group in its Phase I/II trial testing INKmune™ for men with metastatic castration-resistant prostate cancer. The trial’s initial cohort showed that the treatment is very safe, with all patients receiving the therapy as outpatients without needing pre-medication. Even at the lowest dose, the study observed clear, lasting immune effects. Blood sample analysis from three patients revealed that INKmune™ improved the activity and function of natural killer (NK) cells. Two out of the three patients exhibited an increase in circulating activated NK cells, and all maintained enhanced NK cell function for more than 40 days after treatment. One patient experienced a temporary PSA reduction of 21%, correlating with the improved NK cell performance. These promising outcomes set the stage for the next higher-dose groups in the ongoing trial.
Read Announcement- Drug:
- INKmune
- Announced Date:
- July 23, 2024
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio announced the publication of our landmark paper in Journal Immunotherapy of Cancer co-authored by Mark Lowdell, PhD, INmune's Chief Scientific Officer, titled, " Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy."
AI Summary
In July 2024, INmune Bio announced the publication of a landmark paper in the Journal Immunotherapy of Cancer, co-authored by Chief Scientific Officer Mark Lowdell, PhD. The paper, titled “Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy,” details how their INKmune™ priming method creates memory-like natural killer (mlNK) cells with strong anti-tumor capabilities. The study showed that these mlNK cells, even when derived from cancer patients, are as effective as those from healthy donors. It provides new insights into the proteins and metabolic adaptations that help mlNK cells survive in the challenging, low-nutrient environment of tumors. Notably, it is the first study to demonstrate the in vivo generation and persistence of mlNK cells post-treatment, a promising step that supports the ongoing clinical trial in metastatic castration-resistant prostate cancer.
Read Announcement- Drug:
- INKmune
- Announced Date:
- April 29, 2024
- Indication:
- High-Risk Myelodysplastic Syndrome (MDS)
Announcement
INmune Bio announce the successful completion of the first cohort in the trial. Following review by the Safety Review Committee (SRC), approval has been granted to proceed with the second dose level (cohort 2).
AI Summary
INmune Bio announced that the first cohort of its Phase I/II trial for metastatic castration-resistant prostate cancer has been successfully completed. After a careful review by the Safety Review Committee (SRC), the company received approval to proceed to the second dose level, starting with cohort two. The trial is designed to test the safety of the NK cell therapy, INKmune™, which works by converting the patient’s natural killer cells into memory-like cells that can target and destroy cancer cells. So far, the therapy has been safely administered on an outpatient basis, with the initial patients showing no significant adverse events. With the selection and screening of the first patient for the second cohort underway, this milestone represents a promising advance in the clinical evaluation of INKmune for prostate cancer treatment. The progress reinforces the therapy’s potential to provide a new avenue of treatment for patients.
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XPro - FDA Regulatory Timeline and Events
XPro is a drug developed by INmune Bio for the following indication: For treatment of Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XPro
- Announced Date:
- June 30, 2025
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
AI Summary
INmune Bio announced key findings from its Phase 2 MINDFuL trial evaluating XPro™ in early Alzheimer’s disease. Although the study did not meet its primary cognitive endpoint (EMACC) in the full modified intent-to-treat group of 200 patients, a predefined subgroup of 100 amyloid-positive patients with two or more inflammation biomarkers showed notable benefits. In this subgroup, XPro™ demonstrated a positive effect on cognitive performance, behavior (as measured by the Neuropsychiatric Inventory), and a reduction in the AD biomarker pTau217 when compared to placebo.
XPro™ was generally safe and well-tolerated, including among high-risk ApoE4+/+ patients, with no observed ARIA-E or ARIA-H events. The most common side effects were mild injection site reactions. These promising findings pave the way for further analysis and potential Breakthrough Therapy Designation with the FDA.
Read Announcement- Drug:
- XPro
- Announced Date:
- June 10, 2025
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio, Inc. a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease is collaborating with Kirsty Dixon PhD, Assoc Prof. of Surgery at Virginia Commonwealth University in Richmond, Virginia on the interaction of TBI and AD. Prof Dixon and her team presented a poster at the Keystone Symposia's Neurodegeneration section: Linking Cellular Pathways to Therapeutic Strategies in Whistler, British Columbia, Canada.
AI Summary
INmune Bio, Inc., a clinical-stage inflammation and immunology company, is partnering with Dr. Kirsty Dixon, Associate Professor of Surgery at Virginia Commonwealth University, to study the link between traumatic brain injury (TBI) and Alzheimer’s disease (AD). Dr. Dixon and her team presented a poster at the Keystone Symposia’s Neurodegeneration session in Whistler, British Columbia, where they detailed their findings. Their research shows that TBI increases amyloid deposition in animal models, an effect associated with heightened AD risk. The study also revealed that treatment with INmune Bio’s XPro™ greatly reduced amyloid formation and improved overall brain function. This collaboration highlights a promising approach where targeting TBI-induced inflammation could potentially mitigate the progression of AD, paving the way for new therapeutic strategies that harness the patient’s innate immune system to combat neurodegeneration.
Read Announcement- Drug:
- XPro
- Announced Date:
- July 29, 2024
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio is pleased to be presenting results of a new and advanced proteomic analysis at this year's annual Alzheimer's Association International Conference (AAIC) in Philadelphia, PA.
AI Summary
INmune Bio is excited to present new results using advanced proteomic analysis at this year’s Alzheimer's Association International Conference in Philadelphia, PA. The study looked at changes in the cerebrospinal fluid of Alzheimer’s patients treated with XPro™, a next-generation inhibitor targeting soluble TNF. Researchers found that a 12-week treatment led to significant changes in synaptic proteins that are vital for communication between neurons. This modulation indicates that the treatment may help restore normal synaptic function, which is important because the loss of synapses is linked to cognitive decline in Alzheimer’s disease.
The findings support previous research showing that normalizing immune function can have a positive impact on neuron communication. INmune Bio’s presentation underscores the potential of XPro™ in improving synaptic health, a promising sign for therapies aimed at addressing the cell-level changes that occur in Alzheimer’s disease.
Read Announcement- Drug:
- XPro
- Announced Date:
- April 30, 2024
- Indication:
- For treatment of Alzheimer's Disease
Announcement
INmune Bio is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer's Disease (AD) for more than three years under the Australian compassionate use program known as the Special Access Scheme (SAS).
AI Summary
INmune Bio recently shared positive updates about two Alzheimer's patients who participated in the Phase 1b trial and have been receiving XPro™ for over three years through Australia’s Special Access Scheme (SAS). Both Patient 1 and Patient 2, who originally enrolled in the 2019 study, continued their treatment beyond the trial’s open-label extension phase under compassionate use. Their primary care physicians reported that XPro™ has been well-tolerated, with both patients maintaining stable cognitive function throughout the treatment period. The physicians highlighted that neither patient experienced significant adverse reactions, and both are keen to continue with XPro™ due to the observed stability in their condition. This long-term treatment via the SAS offers encouraging insights for managing Alzheimer’s Disease and demonstrates the potential of XPro™ as an ongoing treatment option for patients with AD.
Read Announcement
XPro1595 - FDA Regulatory Timeline and Events
XPro1595 is a drug developed by INmune Bio for the following indication: Alzheimer’s disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XPro1595
- Announced Date:
- March 27, 2025
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio provides a business update.
AI Summary
INmune Bio recently provided a comprehensive business update that highlighted progress across its clinical and corporate programs. The company shared key developments from its pipeline, especially in its DN-TNF platform with XPro™, designed to impact neuroinflammation in early Alzheimer’s disease patients. Interim analyses from its Phase 2 AD02 trial showed robust performance of its novel cognitive measure, EMACC, which effectively differentiated between prodromal and mild dementia stages.
The update also covered encouraging early results from the INKmune® trial in metastatic castration-resistant prostate cancer, demonstrating increased NK cell activity in patients. Additionally, INmune Bio detailed its ongoing work on CORDStrom™ for treating epidermolysis bullosa in pediatric patients, along with recent corporate financing activities and milestone achievements in supply chain and manufacturing enhancements. These advancements support the company’s strategy to advance treatments for immune and inflammatory conditions.
Read Announcement- Drug:
- XPro1595
- Announced Date:
- April 23, 2024
- Indication:
- Alzheimer’s disease
Announcement
INmune Bio, announcedthe successful completion of the extended stability validation for XProTM continuous storage in solution at 2-8C.
AI Summary
INmune Bio, Inc. announced a significant milestone with the successful completion of its extended stability validation for XProTM when stored continuously in solution at 2-8°C. The validation included 24- and 30-month samples that met all chemistry and potency assays. Based on these rigorous tests, the Company is conservatively claiming a 24-month stability period for XProTM, aligning with the stability of similar pegylated cytokines like alpha-interferon.
This achievement not only supports the development of XProTM as it moves toward Phase III and commercial applications but also allows the use of established, temperature-controlled global supply chain systems. The reliable stability profile is essential for the Company's plans to offer the drug in a pre-filled syringe format, making it easier for Alzheimer’s patients and caregivers to store and administer the medication at home.
Read Announcement
