MONTPELLIER, Frankrijk & TOULOUSE, Frankrijk–(BUSINESS WIRE)– Emercell SAS (Emercell) en Cell-Easy SAS (Cell-Easy) hebben vandaag de ondertekening aangekondigd van een strategische overeenkomst voor de opschaling en productie van het hoofdproduct van Emercell.

Emercell heeft een platformtechnologie ontwikkeld om kant-en-klare natural killer (NK)-cellen te produceren. NK-cellen zijn zeer krachtige immuuneffectoren, die alleen als monotherapie of in combinatie met therapeutische antilichamen worden gebruikt, of genetisch gemanipuleerd zijn om chimere antigeenreceptor (CAR)-NK-cellen te produceren voor de behandeling van hematologische maligniteiten en solide tumoren. NK-001 is een geoptimaliseerd celtherapieproduct dat is samengesteld uit sterk geactiveerde en alloreactieve allogene NK-cellen. Het gepatenteerde productieproces maakt een volledige industrialisatie mogelijk door dezelfde batch NK-cellen voor meerdere patiënten te gebruiken.

Emercell and Cell-Easy Sign a Strategic Agreement for the Scale-up and Manufacturing of NK-001

MONTPELLIER, France & TOULOUSE, France–(BUSINESS WIRE)– Emercell SAS (Emercell) and Cell-Easy SAS (Cell-Easy) announced today the signing of a strategic agreement for the scale-up and manufacturing of Emercell’s lead product.

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Emercell has developed a platform technology to produce off-the-shelf natural killer (NK) cells. NK cells are highly potent immune effectors, used alone as monotherapy, or in combination with therapeutic antibodies, or are genetically engineered to produce Chimeric Antigen Receptor (CAR)-NK cells for the treatment of hematological malignancies and solid tumors. NK-001 is an optimized cell therapy product composed of highly activated and alloreactive allogeneic NK cells. Its patented manufacturing process allows a complete industrialization by using the same batch of NK cells for multiple patients.

Cell-Easy is an analytics-driven Contract Development and Manufacturing Organization (CDMO) specialized in the production of Gene-modified Cell and Cell Therapy products. Cell-Easy’s facilities are located in Toulouse including state-of-the-art controlled environment suites optimized for developing manufacturing and analytical processes, proceed to environmental and material Quality Control, and execute cGMP manufacturing, fill & finish, long-term storage of Advanced Therapy Medicinal Products (ATMPs) compliant with all the requirements of regulatory standards and cGMP guidelines.

Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, with the objective to enter clinical phase in 2023. Emercell has signed a strategic agreement with Cell-Easy specialized in the development and production of ATMP.

“We are very pleased to collaborate with Cell-Easy on the final stages of development and GMP manufacturing of our flagship product, NK-001“, said Patrick Henno, President of Emercell.” We are looking forward to a successful and long-lasting collaboration as a key element of our development strategy. Moreover, Cell-Easy and Emercell are located in the Occitanic Region and the partnership fits perfectly with the Region’s objectives regarding the development and production of new products in the field of biotherapies, and particularly in the field of immunotherapy.

In a very competitive European landscape, we are delighted that Emercell has chosen us as their privileged CDMO Partner for their first immune-oncology approach using NK-cells”, said Guillaume Costecalde, President of Cell-Easy. “Cell-Easy CDMAO’s original approach and the team’s reactivity combined with our state-of-the-art facility allow us once again to convince ambitious ATMP developers such as Emercell to secure their development.”

About Emercell

Emercell is an oncology company developing a platform technology to produce off-the-shelf allogenic natural killer (NK) cells. The company’s R&D activities are located at the IRMB (Institute of Regenerative Medicine and Biotherapies) at the Saint-Éloi University Hospital Center, Montpellier, France. Emercell’s lead drug candidate, NK-001, is intended, among others, for the treatment of lymphoma patients who are refractory to conventional therapies. It is a patented process for pre-activating and amplifying allogeneic NK cells. Emercell collaborates with numerous industrial and academic partners. The company has received the support of the Occitanie Region (ADI) and Bpifrance and has obtained a FUI (financing). Emercell is a member of Eurobiomed.

About Cell-Easy

Cell-Easy developed a unique vision of CDMO dedicated to the production of Cell and Gene modified Cell Therapy products. This integrated concept is called CDMAO. Beyond CDMO, CDMAO is not only focused on Development & Manufacturing. CDMAO is positioned as a real partner for helping Biotech & Pharma to bridge the gap between preclinical and clinical development with in-depth expertise on regulatory process scale-up and analytics.

Cell-Easy offers customized process development, process scale-up, cGMP manufacturing and unique analytical services for immune cells (engineered CAR-T, NK, …cells, and non-engineered cells) and adult stem cells (MSCs, iPSCs and Exosomes) both in Immuno-Oncology and Regenerative Medicine fields.

Cell-Easy is a trusted partner and brings today the infrastructure and know-how while ensuring your projects are delivered on time and budget. Supported by highly motivated and experienced people in the Cell Therapy field, Cell-Easy is committed to driving service excellence and actively contribute to a “Bench to Bedside” culture, putting the healthcare of patients at the center of everything.

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Contacts

Media and Investor Contacts:

Emercell, Dr. Patrick Henno, President, patrick.henno@emercell.com, (+33)-6-14-77-39-21

Cell-Easy, Dr. Guillaume Lay, Business Development, Guillaume.lay@cell-easy.com, (+33)-6 15 18 13 13