Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 31

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 31
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 resistant depression (“TRD”); as a drug to prevent muscle
degeneration, prevent fibrosis and promote muscle regeneration in Duchene muscular dystrophy (“DMD”); and as a cancer therapy
to reduce resistance in immunotherapy. The primary focus of the company’s development efforts for XPro is AD. The next indication
to be developed with XPro will be TRD. Treatment of DMD and cancer will occur when partners for the programs are found. The drug is named
differently for the oncology and CNS indications; INB03™ or XPro, respectively, but it is the same drug product. For DMD, the company
is exploring DN-TNF compounds that is optimized for the treatment of DMD. This novel compound has the same mechanism of action but has
novel IP protection. In each case, we believe neutralizing sTNF is a cornerstone to the treatment of these diseases. As an immunotherapy
for cancer, we are using INB03 to neutralize sTNF produced by HER2+ trastuzumab resistant breast cancers to reverse resistance to targeted
therapy. sTNF produced by the tumor causes an up-regulation of MUC4 express causing steric hindrance of trastuzumab binding to the HER
receptor on HER2+ breast cancer cells. Without binding, trastuzumab based therapies are not effective. Neutralizing sTNF reverses MUC4
expression converting a trastuzumab resistant breast cancer cell into a trastuzumab sensitive breast cancer cell. In addition, INB03 may
change the immunobiology of the tumor microenvironment by decreasing the number of immunosuppressive myeloid cells, both myeloid derived
suppressor cells and tumor active macrophages, and increasing the number of cytotoxic lymphocytes and phagocytic macrophages in the TME.
The Company has completed an open label dose escalation trial in cancer patients with metastatic solid tumors that have failed multiple
lines of therapy. The pre-clinical data in MUC4+ expressing tumors and the clinical trial informs the design of a future Phase II trial
by demonstrating that INB03 was safe and well tolerated, defined the dose of INB03 to carry into Phase II trials, and demonstrated a pharmacodynamic
end-point. The company does not plan to commence a Phase II trial in patients with advanced MUC4+ expressing cancer until a partner can
be found.

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