Our objective is to develop and commercialize our product candidates to treat diseases where the innate immune system is not functioning normally and contributing to the patient's disease. This can be in cancer where Natural Killer ("NK") cells are inactive and contribute to a tumor's evasion of the immune system and/or disease progression while Myeloid Derived Suppressor Cells ("MDSC") proliferate to protect the tumor from attack by the patient's immune system or this can be other diseases such as neurologic and metabolic diseases where chronic inflammation results in innate immune system dysfunction and disease progression. Our initial focus will be the treatment of cancer solid tumors and treatment of Alzheimer's Disease. In cancer, we plan to pursue two parallel development programs: (1) with INKmune our first drug candidate, we will initially focus on treating women with relapse refractory ovarian carcinoma; (2) with INB03, we will treat patients with advanced cancers with elevated biomarkers of inflammation including elevated levels of MDSC in their blood. Our third drug candidate XPro1595, targets Alzheimer's Disease which we initiated once we received a non-dilutive funding from the Alzheimer's Association as a $1 million US dollar Part-the-Cloud Award (as described below). Once resources are available, we intend to expand our development programs with INKmune, INB03 and XPro1595 into high risk Myelodysplastic Syndromes ("MDS"), a combination therapy trial with approved checkpoint inhibitors in patients with resistant or refractory to checkpoint inhibitors and other neurodegenerative diseases respectively. The principal components of our strategy to achieve this objective are to:
Copy History · pursue development strategies and regulatory approval pathways that allow the treatment of oncology patients with our lead product candidates, INKmune and INB03; · pursue development strategies and regulatory approval pathways that allow the treatment of neurodegenerative diseases in patients with our lead product candidates, XPro1595; · adopt a product development strategy that solidifies our existing intellectual property ("IP") to prevent competition and expand our IP suite into related immunotherapeutic areas; · provide clear value propositions to third-party payers, such as managed care companies or government programs like Medicare, to merit reimbursement for our product candidates; and · enter into collaborations with other pharmaceutical companies with respect to, among other things, our INKmune and INB03 product candidates and other products that will benefit from development or marketing beyond our current resources.
Pursue development and regulatory approval pathways. We believe INKmune, INB03 and XPro1595 may be approvable under pathways that are potentially shorter than those typically available for drug products based on novel active ingredients, including as an orphan drug under the Orphan Drug Act and approval under the Food and Drug Administration (the "FDA") Accelerated Approval Program (see "Government Regulation"). We have not yet had a discussion with the Medicines and Healthcare Products Regulatory Agency ("MHRA") and/or FDA regarding such designation, but plan to do so in 2019. We believe both our high risk MDS and ovarian carcinoma treatment programs fit the criteria used by the FDA to grant these regulatory designations. We believe that it would take a minimum of six months to receive Orphan Drug status once we submit an application and a minimum of 12 months to receive a designation once we submit an application. We might never have these discussions, submit applications under the Orphan Drug Act as the FDA Accelerated Approval Program or have these applications approved if we do.