Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 20

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 20
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 has been under the
direction of Professor Mark Lowdell. The Company can produce enough INKmune to complete its Phase I clinical trial in men with metastatic
castrate resistant prostate cancer (“mCRPC”). We have validated storage of INKmune for up over 3 years in vapor phase nitrogen
and have a fully scalable, closed system manufacturing process in validation which can produce up to 6 patient doses per week during phase
I and II trials. At intermediate scale we can manufacture 40 doses per week in a single 15-liter bioreactor. Importantly, we have validated
the storage of INKmune at -80oC for up to 27 days which greatly facilitates the delivery and local storage of the drug for
clinical trials and post commercialization use. In contrast, as far as we know all other NK cell therapies and T cell therapies require
complex shipping of drug products in vapor phase nitrogen below -150oC and specialized arrangements for ongoing storage at
the clinical sites. We may need additional INKmune for future clinical trials.

Interaction with Regulatory Authorities Regarding
INKmune Development

The INKmune Phase I studies in high-risk MDS were performed in the United
Kingdom and Greece. We met with the Medicines and Healthcare Products Regulatory Agency (“MHRA”), the United Kingdom version
of the FDA as part of a Scientific Advice Meetings in preparation for submitting the CTA for our first planned program. During March 2024,
the Company decided to terminate further enrollment in the MDS trial due to recruitment difficulties in the European trial sites.

12

INKmune Product Development Path Proposed Phase
I Study in patients with high-risk MDS

During 2021, we initiated
an open label Phase I cancer study in patients with high-risk myelodysplastic syndrome (“MDS”). The first patient was enrolled
in the first quarter of 2021. In the Phase I trial, we planned to treat patients with detectable residual disease in bone marrow and/or
peripheral blood (<15% blasts by conventional tests) with intravenous infusions of INKmune and monitored for changes in peripheral
blood NK activation, NK function and changes in residual blast counts in blood and bone marrow. We and others have previously shown that
MDS patients with inadequate NK function have statistically significantly poorer prognosis than matched patients with normal levels of
NK function (Tsirogianni et al 2019) and we have shown in laboratory experiments that