Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 18

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 18
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we derived INB16 - INKmune. Once the TpNK therapy has been produced and passed quality testing, the patient received conditioning therapy
with chemotherapy (cyclophosphamide and fludarabine), the primed haplo-identical NK cells were given to patients by intravenous infusion.
Two Phase I clinical trials have been performed using that first-generation adoptive cell therapy treatment strategy. An investigator-initiated
trial performed at the Royal Free Hospital in London 2009 was funded by a United Kingdom charity. Fifteen patients with relapsed, high-risk
AML were enrolled in the trial. Because of drop-out due to disease progression, delays in product production and complications of conditioning
therapy, only 7 of the fifteen patients were treated with the TpNK cell product. Four of seven patients showed clear benefit from the
treatment with the TpNK product with prolonged relapse free remission and, in one patient, conversion of a partial remission to full remission.
None of the remissions were durable; all patients ultimately died from disease progression. The safety of the product was found to be
a combination of toxicity from the chemotherapy/radiotherapy conditioning regimen and the TpNK therapy. In general, the complications
were well tolerated although did require medical intervention including prolonged periods of aplasia in two heavily pretreated patients
that resolved with supportive care. The results of this study have been published in a medical journal (PLoS One. 2015 Jun 10;10(6):e0123416.
doi: 10.1371/journal.pone.0123416. eCollection 2015). In 2013, a second open label, multi-center trial was performed in the US using the
same product and procedures but targeting a slightly different patient population. In the second trial, 12 patients in first remission
with AML were treated with the haplo-identical TpNK product produced using the first generation ex-vivo priming process. After conditioning
with chemotherapy alone, the patients received TpNK in three dosing cohorts – 3x10^5, 1x10^6 or 3x10^6 TpNK per kilogram. Patients
were followed for safety and relapse free survival. This trial confirmed the safety of the TpNK treatment in patients with AML and reinforced
many of the efficacy findings seen in the first trial with none of the previously experienced side effects. Patients benefited from