INmune Bio Confirms XPro™ 24-Month Stability for Phase III and Commercialization

INmune Bio, a clinical-stage immunology firm, has confirmed a 24-month stability for its XProTM drug solution stored at 2-8°C. The drug passed all chemistry and potency tests, enabling a 24-month shelf-life claim that aligns with other pegylated cytokines. This stability allows the company to utilize a global supply chain with established systems for temperature-controlled liquid-formulation drugs. The data supports the use of XProTM in a pre-filled syringe for patient convenience, facilitating home storage and self-administration, particularly for Alzheimer's Disease (AD) patients and their caregivers.

RJ Tesi, MD, emphasized the importance of the 24-month stability for the drug's progression to Phase III and commercial use, highlighting the ease of distribution and patient use at the point of care. Furthermore, INmune Bio has developed an innovative anti-drug antibody assay for XProTM that overcomes issues with conventional assays due to the drug's unique trimerization and exchange mechanism. The new assay, using a novel ACE-AG format, will be detailed in an upcoming workshop, and the company has filed a patent application for this innovation.

The company is on schedule to complete a Phase 2 clinical trial for XProTM in treating neuroinflammation-marked Alzheimer’s Disease patients. INmune Bio is a NASDAQ-traded biotech company that focuses on innate immune system-targeting treatments. It has two product platforms in clinical trials: the DN-TNF platform, which selectively neutralizes soluble TNF to treat various diseases, and the Natural Killer Cell Priming Platform, designed to enhance a patient's NK cells to eliminate residual cancer cells. The company's precision medicine approach aims to treat a range of malignancies and chronic inflammations.

The company's success in the development and testing of XProTM is a significant step forward in providing a stable and accessible treatment option for patients, particularly those with AD. The innovative assay and the focus on patient convenience in drug administration underscore INmune Bio's commitment to advancing immunological treatments.