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Sep 22, 2022

 

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

 

MONTPELLIER, France, and TOULOUSE, France, September 22, 2022. 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. 

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.

 

CONTACT: 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

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News & Events

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

Sep 22, 2022

EMERCELL Signs Strategic Partnership with Onward Therapeutics for the Development of its NK Cell Therapy Technology

Feb 17, 2021

Onward Therapeutics Made a Second Strategic Equity Investment in Emercell for Their NK Cell Technology in Cancer Immunotherapy

Jun 20, 2022

Feb 17, 2021

 

Emercell Signs Strategic Partnership with Onward Therapeutics for the Development of its NK Cell Therapy Technology

 

MONTPELLIER, France- Emercell, a biotechnology company developing immunotherapies and cell-based therapies for oncology targets through to pharmaceutical development, announces the signature of a strategic partnership with Onward Therapeutics. The significant investment, of a confidential amount, will be made in three instalments that will allow Emercell to reach the first human clinical trials.

"We are delighted to partner with Onward Therapeutics, whose teams have recognized expertise in the development of new drugs in oncology and with whom we have strong synergies. Their participation is a recognition of our expertise and will allow us to accelerate our development," said Patrick Henno, founder and Chairman of Emercell.

“We are pleased to collaborate with Emercell to scale up their patented process of activation and amplification of the allogeneic NK cells for clinical development,” said Dr. C. Grace Yeh, Chairman and CEO of Onward. “Accessing to the highly activated NK cells allows Onward to explore their potentials for improved efficacy in the immunotherapy for cancer patients.”

During the last few years, Emercell, with the support of the Italian company Bioline diagnostici, has developed and patented, in partnership with the University Hospital of Montpellier, the University of Montpellier and Inserm, a process for the production of a therapeutic tool composed of NK cells. EMERCell is now focusing on the development of its first product, NK-001, a new innovative therapy drug (ATMP) for the treatment of cancer.

About Onward Therapeutics 


Onward Therapeutics is a development stage oncology company, focusing on the identification and development of innovative medicines for the treatment of cancer.

About Emercell 

 

Emercell was created in February 2013 and is located at the IRMB (Institute of Regenerative Medicine and Biotherapies) at the Saint-Eloi University Hospital Center, Montpellier, France. One of Emercell's lead drug candidates, NK-001, is intended for the treatment of CD20-positive lymphomas in patients refractory to conventional therapies. It is a patented process for pre-activating and amplifying the effects of allogeneic NK (Natural Killer) 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.

Jun 20, 2022

 

Onward Therapeutics Made a Second Strategic Equity Investment in Emercell for Their NK Cell Technology in Cancer Immunotherapy

 

Onward Therapeutics SA (Onward Therapeutics) and Emercell SAS (Emercell) announced today the recent exercise of Onward Therapeutics' second of three instalments of equity investment in Emercell. With this investment, Onward Therapeutics has become Emercell's majority shareholder.

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 a 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 consisting of highly activated and alloreactive allogeneic NK cells. Its patented manufacturing process allows full industrialization using the same batch of NK cells for multiple patients.

"This second equity investment in Emercell confirms that the NK-001 project has been advancing well since our first equity investment in February 2021, and we will be able to scale up and industrialize the production of activated NK cells rapidly, to offer new treatments for cancer patients," said Dr. C. Grace Yeh, Chairman and CEO of Onward Therapeutics.

"We are pleased that the collaboration with Onward Therapeutics has reached another critical milestone. Their investment allows us to pursue the NK-001 project and focus on the production of clinical batches," declared Dr. Patrick Henno, Founder and CEO of Emercell. "We can also start looking at further optimizing our production process for NK cells and exploring other potential new cell therapies," commented Dr. Alain Herrera, Chairman of the board of Emercell.

About Onward Therapeutics 

Onward Therapeutics is an oncology company focusing on the identification and development of innovative medicines for the treatment of cancer. The Company, led by an experienced team in translational science and drug development, acquires licenses for potential development candidates and invests in partners with transformative technology platforms. Onward Therapeutics licensed a preclinical stage bispecific antibody (OT-A201) targeting two immune checkpoints from Biomunex Pharmaceuticals SAS, Paris, France; has an exclusive option to a worldwide license agreement for an onco-metabolism program with Institut du Cancer de Montpellier (ICM); and collaborates with Emercell SAS, Montpellier, France, in the development of NK-001, allogenic natural killer cells. In addition, the Company invested in Biomunex Pharmaceuticals SAS for their multi-specific antibody platform, and in Emercell SAS for their NK cell technology. The company is headquartered at Biopôle (a life sciences campus in Epalinges), near Lausanne, Switzerland, has an affiliate in Paris, France, and an office in Taipei, Taiwan.

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 (Natural Killer) 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.