INmune Bio evaluates expanded access requests on a case-by-case basis, guided by the following principles:

• Patient safety is the highest priority.
• Expanded access must not interfere with ongoing or planned clinical development.
• Sufficient clinical and manufacturing data must be available to support reasonably safe use.
• Adequate drug supply and operational resources must be available.
• Requests must comply with applicable regulatory and ethical requirements.

Granting expanded access is not guaranteed, even if the criteria below are met.

INmune Bio may consider expanded access requests for XPro1595 when all of the following conditions are satisfied:

1. Serious or Life-Threatening Disease
The patient has a serious or immediately life-threatening condition.

2. Lack of Comparable Alternatives
No comparable or satisfactory FDA-approved therapies are available, or the patient has exhausted such options.

3. Ineligibility for Clinical Trials
The patient is unable to participate in an ongoing or planned clinical trial of XPro1595 due to eligibility criteria, geographic limitations, or other documented reasons.

4. Favorable Risk–Benefit Assessment
Available clinical and nonclinical data support a determination that the potential benefits outweigh the potential risks for the individual patient.

5. Regulatory Authorization
The treating physician is willing and able to submit an expanded access request and obtain Institutional Review Board (IRB) approval, as required.

Expanded access may be declined due to one or more of the following considerations:

• Insufficient safety or efficacy data at the time of the request
• Limited drug supply or manufacturing capacity
• Potential impact on enrollment, conduct, or integrity of clinical trials
• Inability to adequately monitor patient safety
• Regulatory or legal constraints

INmune Bio does not currently offer expanded access through an open-label, intermediate-size population, or treatment expanded access program.

If expanded access is granted:

• INmune Bio may, where permitted by law, seek reimbursement for direct costs associated with manufacturing, packaging, shipping, and handling.
• The treating physician and institution are responsible for patient care, monitoring, adverse event reporting, and regulatory compliance.

Requests for expanded access must be initiated by a licensed treating physician.

Physicians should submit the following information:

• Patient diagnosis and relevant medical history
• Rationale for expanded access and lack of alternative treatment options
• Confirmation that the patient is unable to enroll in an ongoing clinical trial
• Proposed treatment plan and safety monitoring strategy

Requests should be sent to:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Subject Line: Expanded Access Request – XPro1595

INmune Bio anticipates acknowledging receipt of expanded access requests within 5–10 business days, depending on the completeness of the request and the urgency of the clinical situation.

This Expanded Access Policy may be revised periodically as additional clinical data become available or as INmune Bio's development programs evolve. The most current version will be maintained on the INmune Bio website.

Publication of this Expanded Access Policy does not create a right or entitlement to receive XPro1595. All decisions regarding expanded access remain at the sole discretion of INmune Bio.

FDA authorization of an expanded access request does not obligate INmune Bio to provide the investigational product.