INB03 Development philosophy
There are four core elements to our development philosophy.
- INB03 is targeted at patients who have increased MDSC in their blood and/or tumor microenvironment (found in the biopsy specimen). By chosing patients with elevated MDSC, we are chosing patients that can potentially benefit from INB03 therapy.
- Patients will be treated for 3 months in the clinical trials. If the patients show benefit from INB03, the company is committed to finding a way to continue treatment of the patients. Although this commitment cannot be guaranteed, we will do our best to honor it.
- 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 INB03 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 INB03 is having the effect on the patient’s immune system that we expect. We have developed a set of assays that allows us to determine of INB03 is having the expected effects on the MDSC and the patient’s immune system. These biomarkers allow us to manage risk by more precisely choosing the proper dose of INB03 for the Phase II trial and allowing everyone to understand that the pre-clinical biology is translating faithfully to the clinic.
- INB03 will be first tested as monotherapy. We plan to quickly move to trials testing INB03 in combination with other immunotherapy drugs. Studies have shown that elevated MDSC in the patient’s blood are a risk factor for resistance and relapse after treatment with immunotherapies such as check-point inhibitors(CPI) to CTLA-4. We believe the combination of INB03 in combination with traditional CPI decrease resistance and decrease the development of refractory disease to these remarkable drugs.
Phase I clinical trial in patients with advanced solid tumors with elevated MDSC in their blood
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.
Phase II clinical trial in advanced melanoma patients who are refractory or resistant to CPI and have elevated MDSC in their blood
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.