Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 39

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 39
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 the objectives of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to
be used to monitor participant safety. Regulatory procedures differ in each country we will be working in. For example, in the US, each
protocol is submitted to the FDA as part of the IND for their review and consent before enrolling patients in the clinical trial. The
US is not the only place to perform clinical trials. Most countries have systems in place to allow academics and companies to sponsor
clinical trials of novel therapies in patients. For financial and technical reasons, the Company will perform the Phase I clinical trials
of our programs in the United Kingdom and Australia. The US will be included in the Phase II and//or Phase III programs. Other venues
such as Europe, Canada, Japan and other Pacific Rim countries may be included in the development program in the future. 

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The INB03 Phase I trial has
been completed and provided evidence of safety and a pharmacodynamic drug affect, decrease of inflammatory biomarkers, needed to move
the program to a Phase II clinical trial in cancer. The Phase II clinical trial will combine INB03 with approved second line therapy in
patients with HER2+ breast cancer with or without brain metastasis that have progressed after treatment with TDxd. This is a combination
trial where the addition of INB03 to approved second line therapy may provide a therapeutic alternative in a disease without any drugs
approved. The Company has not lost interest in combining INB03 with immune checkpoint inhibitors (CPI), but competition for patients is
fierce in this arena. Our plan is to pursue treatment of tumors that express MUC4 as our lead indication. Tumors that express MUC4 are
resistant to all forms of immunotherapy due to a combination of increased MDSC in the tumor, decrease tumor macrophage (TAM) phagocytosis,
decreased inflammation in the tumor (a “cold” tumor) and direct effects of MUC4 and soluble TNF on HER2 function. If combination
therapy with INB03 decreases MUC4 expression and changes the TME to make the “cold” tumor “hot”, then addition
of a CPI will be warranted. At this time, the combination trial to treat MUC4+ TDxd resistant HER2+ expressing cancer is our most probable
registration strategy for INB03. This includes the combination of INB03 with trastuzumab antibody drug conjugate therapy TDxd