INKmune™ Development Philosophy
There are four core elements to our development philosophy for INKmune™:
- INKmune™ is being developed to treat residual disease. This means patients will have completed their initial cancer therapy (surgery, radiation and/or 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 our initial clinical trials, patients will receive three months of therapy. This time period may be extended in the future.
- Phase I trials is designed to show safety, evidence of “proof-of-biology” and determine an optimal dose to move in to Phase II “proof-of-concept” clinical trials. Proof-of-biology is a biomarker strategy to determine whether 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 Phase II trials and show that the pre-clinical biology is translating faithfully to the clinic.
- Precision medicine approach to patient selection for INKmune™ therapy will decrease the risk and increase the efficiency of the development process. INmune Bio has developed 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 will respond to INKmune™ therapy. Second, we can monitor the patient’s response to INKmune™ therapy. These assays are designed to predict a positive clinical response to INKmune™ therapy, but this must be verified in clinical trials.
Phase I/II trial in women with high risk ovarian cancer
Our first Phase I/II trial will be conducted 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 allows for the carefully selects trial participant and the seamless move to a randomized Phase II trial.
Phase I/II trial in patients with high risk MDS
Our first Phase I/II trial in hematologic malignancy will be conducted in patients with myeloid dysplasia (MDS) who show a limited or partial response to chemotherapy and continue to have 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. Following an initial Phase I stage to determine the safety of IV administration, the trial will move seamlessly to a randomized Phase II trial.