Patients with Alzheimer’s Disease show improvement in brainwaves following 4 weeks of XPro™ therapy.

Boca Raton, Florida, March 05, 2024 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) reports significant improvements in electroencephalography (EEG), a biomarker of brain function, in patients with moderate to severe Alzheimer’s Disease treated with XPro™ for four weeks.

Patients who received weekly XPro™ treatment for four weeks had a statistically significant increase in Alpha wave frequency and power (p<0.05). Reduced Alpha power is linked with cognitive decline and the progression of Alzheimer’s Disease. Alpha waves represent synchronized brain network activity that are essential for internal functions like mental arithmetic, short-term and working memory, and visual-spatial mental imagery exercises.  In individuals with AD, Alpha wave power is diminished due to the breakdown of brain networks associated with degeneration.

"Functional benefits are the true benchmark of a drugs biological efficacy, and these promising findings are part of a larger narrative that's still unfolding,” stated CJ Barnum, PhD, VP of Neuroscience at INmune Bio.  “We are committed to extensive research, drawing from our Phase 2 placebo-controlled trial to substantiate these findings.”

The seven patient pilot study in patients with moderate to severe AD sought to evaluate the utility of EEG as a functional biomarker of target engagement in evaluating the effects of XPro™ (XPro1595; pegipanermin), a next generation dominant-negative inhibitor of soluble TNF, in AD patients. These positive results support and add to the findings of the Phase 1 study in patients with AD that showed XPro™ treatment reduced biomarkers of inflammation and improved biomarkers of neurodegeneration, synaptic function and improved brain microstructure and promoted remyelination. The extent to which these biomarker changes impact cognition in patients with Early Alzheimer's Disease is currently being assessed in our ongoing randomized, placebo-controlled Phase 2 trial.

EEG, long considered a gold standard in objectively measuring brain activity, provides valuable insight into neural connectivity. Neurological research has consistently highlighted a progressive decline in alpha band power and frequency in individuals with MCI and Alzheimer's disease. EEG's capability to assess brain function makes these findings particularly noteworthy for INmune Bio’s novel treatment strategy. The use of EEG as a biomarker for brain function and its potential as a regular measure in clinical trials was facilitated by Cumulus Neuroscience’s innovative, FDA approved, portable EEG device.

“It is unprecedented to continuously monitor brain function at this scale. Our goal is to bring reliable, clinic-level brain function measurement into the comfort and familiarity of a patient's home,” remarked Brian Murphy, Ph.D., Chief Scientific Officer of Cumulus Neuroscience. "The work highlights the untapped potential in utilizing task-synchronized EEG throughout the drug-development process in patients with Alzheimer’s disease, which could revolutionize how clinical trials are conducted and treatments are evaluated."

Echoing this sentiment, Dr. Barnum emphasized, "Our work with Cumulus Neuroscience is forging new paths in Alzheimer's research, by empowering us with the ability to observe real-time effects of XPro™ on brain function directly within patients’ everyday lives."

About EEG and Alpha Band Power in AD

EEG is the gold standard for measuring brain activity; informing on how well neurons are connected within the brain. Quantitative EEG is reported by the frequency and magnitude of the electrical signal. The frequency of the EEG is categorized by bands that correspond to distinct brain activities and states whereas the magnitude measures how active the neurons are within each band.

The alpha band power, defined around the 8 to 12 Hz frequency band, increases during internal tasks such as mental calculation, short-term and working memory or visual-spatial mental imagery exercises (Vaitl et al., 2005; Klimesch, Sauseng and Hanslmayr, 2007; Palva and Palva, 2007; Lutz, Dunne, and Davidson, 2012). It broadly reflects coordinated network activity in the brain and is expected to be reduced by the “disconnection” of networks seen in neurodegeneration.

In the context of natural aging, alpha power magnitude and frequency has been observed to reduce over the lifespan (Klimesch, 1999; Scally et al., 2018) and positively correlate with individual level of cognitive performance among a group of people of a similar age (Clark et al., 2004). In diseased populations, there is broad evidence connecting a fall in alpha power and frequency to cognitive decline and disease progression (Babiloni et al., 2020; Lejko et al., 2020). Reductions in alpha power and frequency are also associated with traumatic brain injury and have been observed to increase during recovery (Ianof and Anghinah, 2017; Conley et al., 2018).  Specifically, global reduction in alpha power and frequencies are observed in MCI (Mild Cognitive Impairment) patients compared to healthy older adults, and progressive MCI is characterized by lower resting alpha power and frequencies compared to stable MCI (Lejko et al., 2020). Longitudinal studies in AD patients have also reported lower magnitude and frequency of alpha rhythms after yearly follow-up (Babiloni et al., 2020, 2024).

About INmune Bio, Inc.

INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. XPRO, the first of several DN-TNF products, is in clinical trials to determine if it can treat patients with Mild Alzheimer’s disease. Additional therapeutic indications including d treatment-resistant depression and oncology will be pursued when resources allow. The Natural Killer Cell Priming Platform includes INKmune™, a therapy developed to prime a patient’s NK cells to treat patients with cancer. INKmune uses a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies. The INKmune trial is enrolling patients into a US Phase I/II trial in men with metastatic castrate resistant prostate cancer. To learn more, please visit www.inmunebio.com.

About Cumulus Neuroscience

With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. Designed for and with ten of the world's leading pharma companies, the platform enables decentralized trials, and is already making a difference in the development of therapies for Alzheimer's Disease, depression, and schizophrenia.

Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise and key industry partnerships to capture substantial amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient's home – all with an EEG headset synchronized to a novel, tablet-based neuro-assessment platform. Together with machine learning (ML) analytics and the world's largest database of annotated, longitudinal, neurofunctional data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes.

The Company is supported by experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board

Forward Looking Statements

Clinical trials are in the early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss, CFO
(858) 964-3720
info@inmunenbio.com

Investor Contact:
Jason Nelson, Core IR
(516) 842-9614 x-823

Cumulus Neuroscience Contact:

Julie Dietel
FINN Partners for Cumulus
julie.dietel@finnpartners.com
Tel: 978.502.7705