Welcome to our dedicated page for Inmune Bio news (Ticker: INMB), a resource for investors and traders seeking the latest updates and insights on Inmune Bio stock.
INmune Bio Inc. (NASDAQ: INMB) is a clinical-stage biotechnology company focused on developing novel immunotherapies that leverage the body’s innate immune system to fight cancer and other diseases. The company has a robust pipeline of product candidates, including INKmune™, INB03™, XPro™, and LIVNate™.
The company’s leading product, INKmune™, is designed to prime a patient’s natural killer (NK) cells to target and eliminate cancer cells that remain after initial treatment, thereby preventing relapse. By enhancing the functionality of NK cells, INKmune™ aims to boost the body’s ability to control residual disease, potentially extending patient survival.
INmune Bio’s INB03™ is a dominant-negative tumor necrosis factor (DN-TNF) inhibitor targeting high-risk breast cancers expressing MUC4 and triple-negative breast cancer (TNBC). Recent data presented at the American Association of Cancer Research in San Diego highlighted INB03™’s potential to decrease T cell and macrophage immune checkpoint proteins and reduce the metastatic potential of TNBC.
The company has also achieved significant milestones with XPro™, a treatment for Alzheimer’s Disease. INmune Bio recently announced the successful completion of the extended stability validation for continuous storage of XPro™ in solution, confirming its 24-month stability. The company is preparing for Phase III trials and commercial applications, leveraging established global distribution systems.
In addition, INmune Bio has entered into definitive agreements for the sale and purchase of nearly 1 million shares of its common stock and warrants, generating gross proceeds of approximately $9.7 million. These funds are earmarked to support ongoing clinical trials, including the Phase 2 trial for Alzheimer’s Disease and the Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC) using INKmune™.
The company’s management has focused on ensuring the safety and efficacy of their treatments. Recently, INKmune™ has shown promising results in initial clinical trials for mCRPC, with no significant adverse events reported, and approvals to proceed with further dosing cohorts.
For investors and stakeholders, INmune Bio provides a unique investment opportunity, combining cutting-edge science with a commitment to improving patient outcomes through innovative immunotherapy solutions. For more information, visit www.inmunebio.com.
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.
INmune Bio (NASDAQ: INMB) announces publication in Cell Reports demonstrating XPro™'s ability to promote remyelination in demyelinating disease animal models. The study, led by Dr. Leslie Probert at Hellenic Pasteur Institute, shows that XPro1595 converts microglia from damaging to reparative cells by blocking soluble TNF. This research has implications for treating various CNS diseases, including Alzheimer's Disease, where myelin loss compromises neuron function. The company expects to report top-line cognitive results from its Phase II Early AD patients trial in first half of 2025.
INmune Bio (NASDAQ: INMB) has announced it will host a conference call on October 31, 2024, at 4:30 PM EDT to discuss its third quarter 2024 financial results and provide a corporate update. The clinical-stage inflammation and immunology company, which focuses on microglial activation and neuroinflammation in Alzheimer's Disease, will make the call available via phone and webcast. A transcript will be provided approximately 24 hours after the call, and a replay will be accessible through November 7, 2024.
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