OmniScience Inc. and INmune Bio Inc. Partner to Accelerate a Phase 2 Alzheimer's Trial with Vivo, a Novel genAI Clinical Trial Control Tower

Vivo Empowers Clinical Development Teams to Accelerate Decision-making and Analyses in Clinical Trials for Improved Outcomes

HOUSTON and BOCA RATON, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- OmniScience and INmune Bio (NASDAQ:INMB) today announced a pioneering partnership to revolutionize operations for INmune Bio's global Phase 2 Alzheimer's disease (AD) clinical trial (the "AD02 trial") using OmniScience's flagship product, Vivo, an industry-first, genAI-powered control tower designed specifically for centralizing and analyzing vast clinical data in real time. This solution represents a innovative approach to clinical research, delivering immediate insights that enhance decision-making and transform traditional, time-consuming trial management.

Vivo securely unifies data across sources including electronic data capture (EDC), clinical trial management systems (CTMS), patient-reported outcomes (PROs)/clinical outcome assessments (COAs), labs, sensors/wearables, safety databases, and more. With fully integrated data, Vivo goes beyond dashboard visualizations to enable clinical trial teams to improve their decision-making, accelerate timelines, enhance patient safety, and ultimately improve health outcomes. Designed with explainability and interpretability at its core, Vivo ensures that every generated insight is supported by clear, traceable rationale grounded in data and clinical context. Its advanced cognitive architecture combines ontological knowledge of trial protocols with domain-specific clinical expertise, enabling qualitative and quantitative reasoning at scale.

INmune Bio recently announced it completed randomization of patients for its blinded AD02 trial for patients with early AD and biomarkers of elevated neuroinflammation. The trial overenrolled with a total of 208 patients, 56% of whom were categorized as mild AD and 44% as mild cognitive impairment. INmune Bio plans to release top-line cognitive results in the second quarter of 2025.

"A global trial of this size is vast, and Vivo will be critical in our ability to analyze cognitive results," stated Tara Lehner, INmune Bio's VP of Clinical Operations. "With genAI provided by Vivo, we can amplify our clinical teams' capabilities, turning complex data into actionable insights at unprecedented speed, which means we can get answers—and treatments—to patients faster."

INmune and OmniScience partnered throughout Vivo's product development and have completed the first phase of Vivo's roll-out to INmune's clinical development team. Throughout the initial rollout, significant beneficial findings include:

• Improved data quality through Vivo's automatic identification of data discrepancies
  
  
• Enhanced visualization of COAs, supporting identification of outliers and better understanding of population distributions
  
  
• Real-time answers, supporting decisions on patient enrollment criteria, even while the patient is in the clinic
  
  
• Reduced reliance on time-consuming spreadsheet-based data analysis, improving collaboration between clinical and executive teams
  
  

"OmniScience and INmune Bio share a vision to transform how clinical trial teams engage with data – transforming data into knowledge in real time and informing decisions that increase the probability of success," shared Angela Holmes, CEO of OmniScience. "As our partnership moves forward, we're gaining further insights from the INmune team that we can integrate into Vivo's roadmap. We look forward to our continued mutual success."

"The future of clinical trials demands smarter solutions, and Vivo embodies this shift," explained Michael Bell, VP of Product, OmniScience. "Through this collaboration, INmune Bio provides continuous feedback that enables OmniScience's development team to evolve Vivo. This hands-on approach builds confidence among users, who see firsthand how genAI can rapidly turn data into answers and transform their day-to-day workflows."

About OmniScience Inc.

OmniScience is a trusted partner to leading life science organizations, advancing clinical R&D missions through unparalleled expertise in clinical data science. We believe in a future where all clinical trial data can be unified and translated into knowledge in real time.

Our expert team has created Vivo, the first and only company in the world to enable GenAI as a control tower, offering on demand insights into live unified clinical trial data. No spreadsheets, no SQL queries, no emails. Vivo revolutionizes the way pharma manages clinical trials and employs generative AI, with the industry's first gen AI assistant for clinical trial operations. Vivo is more than just a platform – it's your new favorite clinical development colleague, poised to transform clinical trial operation teams' day-to-day workflow and ability to optimize trial insights with generative AI. Vivo was recently awarded top honors at the Innovation Showcase at the November 2024 CNS Summit as well as the 2024 Innovation Network Gathering Whale Tank competition.      

To discuss how OmniScience can support your clinical trials, please visit www.omniscience.bio or reach us at [email protected] or on LinkedIn.

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. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Mild Alzheimer's disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient's NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in 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 (XPro™), 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.

For OmniScience:

Media Contact:

Sean Leous

ICR Healthcare

[email protected]

646-866-4012

For INmune Bio Inc.:

David Moss

Co-founder and Chief Financial Officer

(858) 964-3720

[email protected]



Daniel Carlson

Head of Investor Relations

(415) 509-4590

[email protected]

Investor Contact:

Mike Moyer

Managing Director – LifeSci Advisors

[email protected]