Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 19

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 19
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 haplo-identical
TpNK therapy with prolonged relapse free survival including two patients that remain in remission more than 42 months after treatment.
This trial has been published. (Biol Blood Marrow Transplant. 2018 Mar 26. pii: S1083-8791(18)30132-0. doi: 10.1016/j.bbmt.2018.03.019.)
The results of the laboratory and Phase I studies provide evidence that our strategy for treating residual disease is sensible but unproven.

11

Because INKmune primes NK cells to target naturally occurring antigens,
we believe INKmune can be used to treat a wide variety of cancers including hematologic malignancy (AML, MM, CML, high risk MDS) and solid
tumors (renal, prostate, breast, ovarian, pancreas and lung). We expect the list of INKmune sensitive tumors to continue to expand.

The primary role for INKmune
will be an immunotherapy targeting residual disease in patients after debulking cancer therapies such as cytotoxic chemotherapy and surgery.
At this time, we plan to give INKmune as monotherapy. We do not rule out the possibility of using INKmune as part of combination therapy
in the future. We do not expect to need to modify INKmune to treat these additional types of cancer, because we believe INKmune is a universal
cancer therapy where “one size fits all”. We believe for INKmune to receive regulatory approval for each cancer indication,
clinical trials will need to be performed which demonstrate its safety and effectiveness as a treatment for each such cancer. We believe
the difficulty and cost of achieving these labels extensions will decline with each successive approval, if and when achieved. For example,
if INKmune is proven to be effective therapy in patients with castration resistant prostate cancer, we will need to perform separate pivotal
trials for approval in lung, prostate or renal cancer.

Three step process to preparation for INKmune
human clinical trials:

INKmune GMP scale-up for Phase I/II clinical
material

The working cell banks and
individual INKmune product to be used in the patients for the clinical trial have been produced at the Centre for Cell, Gene & Tissue
Therapeutics at Royal Free Hospital / University College London to full cGMP (MHRA MIA(IMP)11149). All manufacturing