There are four core elements to our development philosophy for INKmune.

  1. INKmune™ is being developed to treat residual disease.  This means patients will have completed their initial cancer therapy (surgery, radiation and chemotherapy) and will have a low burden of disease with a high risk of relapse.
  2. Patients will receive multiple doses of INKmune.  To be effective, immunotherapies require repeated dosing over months.  In the initial clinical trials, patients will receive 3 months of therapy.  This may be extended in the future.
  3. Phase I trials must demonstrate safety and evidence of “proof-of-biology”.  The primary goals of a Phase I trial is to demonstrate the safety profile of INKmune™ and to determine the dose to move in to Phase II “proof-of-concept” (POC) clinical trials.  Modern Phase I trials need demonstrated “proof-of-biology” (POB).  What is POB?  POB is a biomarker strategy that allows patients, their clinicians and the company to know if INKmune™ is having the effect on the patient’s immune system that we expect.  We have developed a set of assays that allows us to assess in INKmune™ is priming the patient’s NK cells and if those primed NK cells can now kill tumor cells.  These biomarkers allow us to manage risk by more precisely choosing the proper dose of INKmune™ for the Phase II trial and allowing everyone to understand that the pre-clinical biology is translating faithfully to the clinic.
  4. Precision medicine approach to patient selection will decrease the risk and increase the efficiency of the development process.  INmune Bio has developed to biomarker assays that allow us to monitor the biology of INKmune therapy.  The assays allow us to demonstrate priming the NK cells and killing of a tumor line by the prime NK cells.  There are two advantages to this precision medicine approach.  First, it improves patient selection.  We will only select patients for the clinical trial who are able to INKmune therapy.  Second, we can monitor the patient’s response to INKmune therapy.  These assays should predict a positive clinical response to INKmune therapy, but this must be verified in the clinical trials.

Patients with advance solid tumors (advanced cancer with metastasis) who have elevated number of MDSC in their blood will be eligible.  The clinical trial is designed as a standard open label dose-escalation trial using biomarkers for patients selection.

Patients with advanced melanoma who have been treated with CPI in the past but were found to be resistant to CPI or have developed refractory disease (progression on CPI) who have increased MDSC in their blood will be eligible.  The clinical trial will be a Phase II, open label dose escalation trial with two arms, resistant disease and refractory disease.  Patients will be treated with INB03 in combination with CPI.

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