INmune Bio, Inc. announced the successful completion of the extended stability validation for XProTM continuous storage in solution at 2-8C. The 24 and 30-month stability test samples passed all chemistry and potency assays; allowing the Company to make a conservative claim of 24-month stability. The 24-month stability claim is consistent with other pegylated cytokines, such as alpha-interferon, and allows the Company to design a global supply chain using proven and established systems. With this data, the company can benefit from such existing systems that use temperature controlled and monitored shipment of liquid-formulation drugs at 2-8C, which is routine across the pharmaceutical industry.

The 24-month stability data confirms that XProTM can mirror these established supply chain strategies. In addition to the 24-month stability progress, the Company further announced that it has filed a patent application after it successfully developed an anti-drug antibody assay for XProTM that mitigates false positive readings associated with the application of conventional bridging and affinity capture elution (ACE) formats. Due to XProTM?s unique mechanism, namely trimerization and exchange of monomeric units, the application of such conventional assays can be problematic.

The detection of anti-drug antibodies for XProTM in human serum according to the new assay utilizes a novel ACE-AG format. Details of the assay will be disclosed in the forthcoming 18th Workshops on Recent Issues in Bioanalysis (WRIB) in San Antonio, TX this coming May 7, 2024, with a poster titled ?Anti-Drug Antibody (ADA) Assay for XPro 1595, a Self-Assembling Trimer: Alternative to Standard Bridging or ACE Approaches?. ?This new assay is the product of a unique challenge and applied innovation, which has now resulted in the filing of a patent application adding value to the XPro1595 franchise?

said Joshua Schoonover, the Company?s General Counsel. Tho Company remains on track in line with prior guidance to complete its Phase 2 clinical trial involving the use of XProTM for the treatment of Alzheimer?s Disease in patients with biomarkers of neuroinflammation.