Project
NK-001 cell immunotherapy for patients in oncology currently at preclinical step in oncology domain
EMERCell ’s focus is to implement the first steps of the pharmaceutical development of innovative therapeutic products, until the first clinical trials.
Immunotherapy and cell therapy are highly potent therapeutic ways to help body’s immune system and to better fit the current therapeutic needs.
The first project of EMERCell is NK-001, in oncology area.
For the first project of the company, EMERCell is developing a generic cell immunotherapy NK-based to be used in synergy with monoclonal antibodies (MAbs) to treat refractory patients in oncology. This new and innovative drug therapy called NK-001 consists of allogeneic Natural Killer (NK) cells which are activated & amplified ex vivo according to a patented process.
Inside the step 4 :
A NK-based mature cell immunotherapy generic product used in synergy with monoclonal antibodies to treat refractory patients in oncology
Immunotherapy to help natural body defenses
Mature cell therapy to supply immune-defective patients with highly active effector cells
Highly activated NK cells-based to have a poorly toxic but highly potent effector
Generic product to be used for many patients & many pathologies
Product acting in synergy with monoclonal antibodies to specifically target different pathologies
check No genetic modification
check Generic therapeutic tool to treat different pathologies
check Weak toxicity and genetic instability risks
check Decreased variability
check Weak incidence of endogenous immune system
check Highly activated NK cells
check Alloreactive allogeneic NK cells
check High MAb receptor expression
check Availability of biological raw material
check High quantity of produced cells
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 AML (Acute Myeloid Leukemia). Then NK-001 will be tested with Trastuzumab (or equivalent) on solid tumor expressing HER2.
