Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 22

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 22
---
CPRC. The clinical trial is an
open label Phase I/II trial in men with metastatic castrate resistant prostate cancer. The trial has a modified Baysian design that allows
for a 3 patient Phase I for each dose level followed by a 6 patient Phase II trial. All patients will receive 3 infusions of INKmune on
days 1, 8 and 15. The three doses of INKmune at low, medium and high dose of INKmune is 1x10^8, 3x10^8 or 5 x10^8 cells per infusion respectively.
INKmune infusions are given as an out-patient with the use of pre-medication or additional cytokines. Patients are carefully monitored
for 6 months after the first dose of INKmune. There are four goals of the trial – determine safety in the target population; immunologic
efficacy, anti-tumor effects and select a dose for the pivotal trial. Immunologic efficacy is determined by an increase in the numbers
of memory like NK cells in the circulation of the patient and how long that increase lasts. In general, we are expecting the number of
mlNK to double and to persist in the circulation of the patient for more than 120 days. Anti-tumor effects will be monitored by serial
testing of blood prostatic surface antigen level (blood PSA), prostate-specific membrane antigen
nuclear medicine scan (PMSA scan with piflufolastat F18; Pylarify®) and circulating tumor DNA. The Company enrolled the first
patient in the open label low, medium and high dose Phase I cohorts in DEC23, JUN24 and OCT24 respectively. All patients in the phase
I dose escalation part of the trial have now been treated and the final patient in the Phase II cohorts is expected to be enrolled in
1H25 with data lock 2H25. As an open label trial, there may be opportunities to see patient data during 2025. Other solid cancers are
of interest including nasopharyngeal cancer (“NPC”) which is a known target for NK cells and an important unmet clinical need
in emerging markets such as mainland China. Renal cell carcinoma is also a known target for INKmune. We may seek to partner or sell INKmune.
Although our development strategy is focused on North America and Europe, we believe INKmune will also be