INmune Bio, Inc. to Provide Additional Manufacturing Information to FDA as Part of IND Application for XPro1595™ in Alzheimer’s Disease

Rhea-AI Summary

On May 23, 2022, INmune Bio (NASDAQ: INMB) announced that the FDA placed their Investigational New Drug (IND) application for XPro™ in Alzheimer's treatment on clinical hold, pending additional information regarding Chemistry Manufacturing and Controls (CMC). The official hold letter is expected in approximately 30 days. Meanwhile, the Phase 2 trial for XPro™ continues to enroll patients in Australia. XPro™ is designed to inhibit soluble TNF, potentially reducing neuroinflammation in neurologic diseases.

Positive

• Phase 2 trial of XPro™ remains open and ongoing in Australia, continuing patient enrollment.

Negative

• FDA placed the IND application for XPro™ on clinical hold, indicating potential delays in U.S. trials.
• FDA requires additional information around CMC, which could complicate future approvals.

BOCA RATON, FL., May 23, 2022 (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, today announced that on May 20, 2022, the Company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) requesting additional information around Chemistry Manufacturing and Controls (CMC) of the newly manufactured XPro1595 (XPro™).  As part of the communication, the Agency placed the Company’s Investigational New Drug (IND) application to initiate its Phase 2 clinical trial of XPro™ in patients with Alzheimer’s Disease (AD) in the U.S. on clinical hold.  The FDA indicated they will provide an official clinical hold letter to INmune in approximately 30 days.  INmune plans to provide additional updates pending discussion with the FDA.  The Phase 2 trial of XPro™ remains open in Australia and continues to enroll patients.

About XPro™

XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

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, 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
DMoss@INmuneBio.com

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

FAQ

What does the FDA's clinical hold on INmune Bio's XPro™ mean?

The FDA's clinical hold means that INmune Bio cannot proceed with the Phase 2 clinical trial for XPro™ in the U.S. until they provide additional information requested by the agency.

When will INmune Bio receive the official clinical hold letter from the FDA?

INmune Bio expects to receive the official clinical hold letter from the FDA in approximately 30 days.

Is the Phase 2 trial for XPro™ still active?

Yes, the Phase 2 trial for XPro™ remains active in Australia and is continuing to enroll patients.

What is XPro™ developed by INmune Bio targeting?

XPro™ is targeting neuroinflammation in Alzheimer's Disease by inhibiting soluble TNF.