NK-001 project : new Advanced Therapy Medicinal Product (ATMP) development using a patented process to amplify and activate allogeneic Natural Killer (NK) cells.
NK-001 project has been presented twice at the French Regulatory Authorities (ANSM), in 2012 before EMERCell creation, and in 2016 for a review of the preclinical & clinical development plans.
The impact of the association between EMERCell NK and monoclonal antibodies directed against tumor antigens is currently being evaluated: a collaborative program funded by the Fonds Unique Interministériel (a French governmental funding) on B lymphoma is ongoing.”
Q4 2017, in vivo proof of concept & preclinical regulatory experiments are ongoing on immunodeficient mice for B lymphoma application.
After NK-001 therapeutic tool industrial production, NK cells being hematological cells, the proof of concept is suggested initially in the treatment of onco-hematological pathologies: First phase in CD20 refractory lymphoma with a clinically well-known MAb (Rituximab), and second phase in refractory Acute Myeloid Leukemia (AML). Then NK-001 will be tested with Trastuzumab (or equivalent) on solid tumor expressing HER2.