INKmune Development philosophy
There are four core elements to our development philosopy for INKmune.
- 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.
- 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.
- 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.
- 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 that will respond 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.
Phase I/II trial in patients with high risk MDS
Our first Phase I/II trial in hematologic malignancy will be in patients with myeloid dysplasia (MDS) who have made a limited or partial response to chemotherapy and remain with detectable myeloid blasts in their bone marrow. Most, if not all of these patients, will have failed first line therapy. The trials will be performed at academic medical centers in the UK and beyond. The open label Phase I/II trial will use a precision medicine design that carefully selects patients with the highest capacity to respond to the therapy. After the initial phase I stage to determine the safety of i.v. administration the trial will move seamlessly to a randomized Phase II trial.
Phase I/II trial in women with high risk ovarian cancer
Our first Phase I/II trial in epithelial cancers will be in women with relapsed ovarian cancer. These women will have failed chemotherapy but have a low burden of disease as determined by standard testing. The trials will be performed at academic medical centers in the UK and beyond. The open label Phase I trial will use a precision medicine design that carefully selects patients to participate in the trial and move seamlessly to a randomized Phase II trial.