INmune Bio Inc. Announces 24-Month Stability Validation of XPro for Phase III Readiness and Commercial Supply Chain Modeling & Development of Novel Immunogenicity Assay

Boca Raton, Florida, April 23, 2024 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is delighted to announce the successful completion of the extended stability validation for XPro^TM 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 XPro^TM can mirror these established supply chain strategies.

“24-month stability is essential for our plans to use XPro^TM as we move towards Phase III and commercial applications and allows us to utilize a well-established global distribution system,” said RJ Tesi, MD. “Distribution is only part of the product supply equation.  Use at the point of care by the patient is equally important.  We hope to provide XPro^TM in a pre-filled syringe format for easy home storage and self-administration by AD patients and their caregivers.”

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 XPro^TM that mitigates false positive readings associated with the application of conventional bridging and affinity capture elution (ACE) formats. Due to XPro^TM’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 XPro^TM in human serum according to the new assay utilizes a novel ACE-AG format. Details of the assay will be disclosed in the forthcoming 18^th 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.