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Overview of INmune Bio Inc
INmune Bio Inc (NASDAQ: INMB) is a clinical-stage biotechnology company specializing in the development of novel immunotherapies. With a unique commitment to harnessing the patient’s innate immune system, the company’s approach is grounded in precision medicine and innovative biological mechanisms. By targeting key drivers of immune dysfunction, INmune Bio aims to address complex and life-threatening conditions in oncology, neurodegenerative diseases, and chronic inflammation.
Core Business and Value Proposition
At its core, INmune Bio concentrates on reprogramming the body’s natural defense mechanisms to combat disease. The company operates two major product platforms, each designed to tackle distinct pathological processes:
- The Dominant-Negative TNF (DN-TNF) Platform: This platform utilizes dominant-negative technology to selectively neutralize soluble tumor necrosis factor (sTNF) without interfering with trans-membrane TNF or TNF receptors. This selective inhibition aims to alleviate chronic inflammation and restore normal immune function. Product candidates within this platform are being assessed in clinical trials for conditions such as cancer, early Alzheimer’s disease, and treatment-resistant psychiatric disorders.
- The Natural Killer (NK) Cell Priming Platform: INKmune, the flagship product of this platform, employs a pharmaceutical-grade, replication-incompetent human tumor cell line to prime resting NK cells into tumor killing memory-like NK cells. This therapy is designed to eliminate residual malignant cells by enhancing the cytotoxic function of NK cells, particularly in a hostile tumor microenvironment where conventional therapies may fall short.
Scientific Foundations and Mechanism of Action
INmune Bio’s approach is deeply rooted in immunology and cellular biology. By targeting the innate immune system, the company seeks to modulate critical pathways that drive chronic disease. The DN-TNF platform focuses on the inflammatory cascade by reducing soluble TNF levels, which may contribute to neuroinflammation and cancer progression. In parallel, the INKmune platform provides multi-channel activation signals to NK cells, thereby converting them into potent, long-lived effectors capable of recognizing and eliminating a broad spectrum of tumors.
Clinical Development and Pipeline
The company’s pipeline is robust and comprehensive, with multiple product candidates under clinical evaluation. The development strategy emphasizes the use of precision medicine techniques tailored to patient-specific biomarkers. Candidates such as INKmune, XPro™, and INB03 are undergoing various stages of clinical trials in diseases ranging from metastatic cancers to early Alzheimer’s disease. Each clinical program is designed to validate the therapeutic potential through a mechanism of action that addresses the underlying pathology at a cellular level.
Market Position and Competitive Landscape
Despite operating in a field characterized by intense competition and rapid scientific advances, INmune Bio differentiates itself with its dual-platform approach and commitment to leveraging both innate immune modulation and precision medicine. While many biotechnology companies focus on a single therapeutic area or mechanism, INmune Bio’s diversified pipeline offers a multi-pronged strategy to tackle residual and treatment-resistant disease. This positioning is integral to its strategy to fill gaps in current treatment paradigms.
Precision Medicine and Patient-Centric Approach
INmune Bio’s research and development are anchored in the principles of precision medicine. By identifying patients with specific biomarkers indicative of immune dysfunction, the company aims to tailor its therapies for maximal efficacy. This patient-centric focus is supported by rigorous clinical trial designs that yield detailed insights into immunologic responses, enhancing the overall therapeutic index of its investigational products.
Clinical Trial Design and Regulatory Environment
The company’s clinical trials are structured to meet high standards of scientific rigor and regulatory compliance. With trial methodologies that integrate novel endpoints and advanced biomarker assessments, every study is designed to generate reproducible and meaningful data. Although all clinical data are subject to the uncertainties inherent in early-stage research, INmune Bio’s protocols underscore its commitment to safety and efficacy without resorting to time-sensitive claims.
Scientific Collaboration and Expertise
INmune Bio benefits from close collaborations with academic institutions, leading clinical researchers, and renowned experts in neuropsychology and immunology. These partnerships reinforce the company’s technical expertise and provide a foundation for its complex therapeutic strategies. The cross-disciplinary collaboration helps ensure that each investigational product is backed by robust preclinical data and a thorough understanding of the underlying disease mechanisms.
Conclusion
In summary, INmune Bio Inc represents a sophisticated and methodical approach to addressing unmet medical needs through innovative immunotherapy solutions. By leveraging two distinct but complementary product platforms, the company works at the intersection of oncology, immunology, and neuroscience. Its rigorous clinical trial programs, focus on precision medicine, and deep-rooted scientific expertise have positioned it as an important player in the evolving landscape of clinical-stage biotechnology. The comprehensive strategy adopted by INmune Bio is a testament to its mission to harness the innate immune system to fight disease in a targeted, efficient, and ultimately patient-friendly manner.
INmune Bio Inc. (NASDAQ: INMB) has released its financial results for the year ended December 31, 2024. The company reported significant progress across its three platform technologies:
For its DN-TNF Platform, the company completed enrollment of 208 patients in its Phase 2 AD02 trial for Early Alzheimer's Disease, with topline results expected in June 2025. The trial demonstrated strong performance of its EMACC cognitive measure tool.
The CORDStrom Platform showed positive results in treating Recessive Dystrophic Epidermolysis Bullosa (RDEB), receiving both Rare Pediatric Disease and Orphan Drug Designations from the FDA. The company plans to file a BLA in 2025 or early 2026.
The INKmune Platform demonstrated safety and increased NK-Cell activity in its Phase I/II trial for metastatic Castration-Resistant Prostate Cancer.
Financially, the company reported a net loss of $42.1 million for 2024, with R&D expenses of $33.2 million. The company raised approximately $27.5 million through securities purchase agreements and had cash and cash equivalents of $20.9 million as of December 31, 2024.
INmune Bio Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, has scheduled its Fourth Quarter 2024 financial results conference call for March 27, 2025, at 4:30 PM EDT. The company will present its financial performance for the quarter ended December 31, 2024, along with a corporate update.
Investors and interested parties can join via phone using the dial-in numbers 1-800-225-9448 or 1-203-518-9708 with Conference ID: INMUNE. A live audio webcast will be available, and a transcript will be provided approximately 24 hours after the call. A replay option will also be accessible.
INmune Bio (NASDAQ: INMB) has successfully completed the Phase I portion of its CaRe PC trial for INKmune™, a Natural Killer (NK) cell therapy treating metastatic castration-resistant prostate cancer (mCRPC). The Scientific Review Committee (SRC) unanimously approved opening all Phase II cohorts after reviewing safety data from the third and highest dose cohort.
The trial, which follows a Bayesian design with three ascending dose cohorts, has demonstrated an exemplary safety profile in outpatient settings. Initial data from the low dose cohort has shown immunologic effects. The Phase II extension will include six patients at the two higher dose levels, with patient recruitment progressing as expected.
The company's CSO, Mark Lowdell, will present the trial data at the 10th Annual Innate Killer Summit in San Diego on March 4th.
INmune Bio (NASDAQ: INMB) announces plans to submit a Biologics License Application (BLA) to the FDA for CORDStrom, targeting the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in pediatric patients. The decision follows positive results from the MissionEB clinical trial, a double-blind, placebo-controlled study involving 30 pediatric patients.
CORDStrom demonstrated significant efficacy, particularly in reducing itch severity by over 27% at 6-months in severe cases, with improvements in skin integrity for younger patients. The treatment received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA. The company estimates approximately 4,500 children with intermediate or severe RDEB in the US, UK, and EU could benefit from this therapy.
The company plans to submit the BLA in 2025, followed by Marketing Authorization Applications in the EU and UK in 2026. A 12-month open-label study is planned to continue supporting patients from the MissionEB trial.
INmune Bio (NASDAQ: INMB) has expanded its Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC) to include the West Los Angeles VA Medical Center, with the first patient treated in the Phase II portion. The trial, known as CarePC, represents a novel NK-targeted biologic therapy approach using INKmune treatment.
The patient received the 'medium' dose of INKmune as an outpatient under Dr. Matthew Rettig's care, who serves as Chief of Hematology-Oncology at VA Greater Los Angeles Healthcare System. The VA system treats approximately 15,000 Veterans diagnosed with prostate cancer annually, with over 200,000 Veterans being prostate cancer survivors. Under Dr. Rettig's leadership, 900 patients have participated in over two dozen clinical trials at the West LA VA Medical Center.
This treatment activates NK cells, which target tumor cells abundant in prostate cancer, and is administered on an outpatient basis with minimal reported side effects.
INmune Bio (NASDAQ: INMB) has announced the complete repayment of its $15.0 million Term Loan from Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. The loan, borrowed in 2021, was fully repaid on December 2, 2024, ahead of its January 1, 2025 maturity date. The company's CFO, David Moss, noted that this repayment will reduce quarterly cash burn and strengthen the balance sheet before upcoming Phase 2 Alzheimer's Disease trial data.
The company also mentioned the over-enrollment of its AD02 Trial in Alzheimer's Disease, focusing on Early AD patients with elevated neuroinflammation biomarkers. Top-line cognitive data from this six-month phase 2 trial is expected in Q2 2025.
INmune Bio (NASDAQ: INMB) and OmniScience have partnered to implement Vivo, a genAI-powered clinical trial control tower, for INmune's global Phase 2 Alzheimer's disease trial. The AD02 trial has completed patient randomization with 208 participants, comprising 56% mild AD and 44% mild cognitive impairment patients.
Vivo unifies data from multiple sources including EDC, CTMS, PROs/COAs, labs, and safety databases, providing real-time insights for improved decision-making. Initial benefits include enhanced data quality through automatic discrepancy identification, improved COA visualization, and real-time decision support for patient enrollment. Top-line cognitive results are expected in Q2 2025.
INmune Bio has completed patient randomization in its Phase 2 trial for Early Alzheimer's Disease (AD02), with a total of 208 enrolled patients. The global, blinded trial focuses on patients with elevated neuroinflammation biomarkers, with 56% categorized as mild AD and 44% as MCI. The study utilizes XPro™, targeting glial cells to reduce neuroinflammation and improve brain function. The primary endpoint measures cognitive function changes after 24 weeks using EMACC and CDR-SB metrics. Top-line cognitive results are expected in the second quarter of 2025.
INmune Bio announced Q3 2024 financial results and business updates. Key highlights include completion of enrollment for Phase 2 Alzheimer's Disease trial with target of 201 patients, and positive interim analysis showing correlation between EMACC and CDR-SB cognitive measures. INKmune™ demonstrated safety and increased NK-Cell activity in prostate cancer trial. The company secured $13.0 million through securities purchase agreements and received a $2.5 million R&D rebate. Financial results show Q3 net loss of $12.1 million, with R&D expenses of $10.1 million. Cash position stands at $33.6 million as of September 30, 2024.
INmune Bio (NASDAQ: INMB) announced a webinar on November 7, 2024, titled 'Why EMACC is the Optimal Tool for Measuring Cognitive Change in Early Alzheimer's Trials'. The event will feature experts discussing EMACC's development and advantages in assessing cognitive changes in early Alzheimer's Disease patients. Additionally, the company will present a poster at the Clinical Trial in Alzheimer's Disease (CTAD) conference in Madrid about EMACC's validation in Phase II trials.
The company is currently conducting a global Phase II trial using XPro™ in Early AD patients, focusing on those with neuroinflammation. The trial's primary endpoint measures cognitive function changes after 6 months using both EMACC and CDR-SB assessments.
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