Development phase

NK-001 Project story

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.

First ANSM meeting focused on project presentation
group
Company creation
domain
NK-001 selection in "34 plans de réindustrialisation de la France"
done
ADI funding, Région Occitanie/BPI
done
NK-001 project eligibility for "20ème AP du FUI"
done
Scientific advice, ANSM development plan review
done
Preclinical data
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in vivo proof of concept & preclinical regulatory experiments are ongoing on immunodeficient mice for B lymphoma application.
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Expected beginning of clinical development
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Development strategy : Which steps ?

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.

1.

Production of a generic NK-based therapeutic tool

2.

Oncohematology

2.1

First proof of concept in CD20+ refractory lymphoma + Rituximab

2.2

Refractory AML

3.

Test on refractory HER2+ solid tumor cells