Cytovia driving CAR NK manufacturing to Puerto Rico

Cytovia Therapeutics will set up a facility in Aguadilla, Puerto Rico to support production of its off-the-shelf iPSC-derived CAR NK therapeutics.

Cell therapy developer Cytovia has signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000 square-foot facility.

The plant, which will include more than 40,000 square feet of cleanroom and biomanufacturing space, will be located in Aguadilla, Puerto Rico, and the firm says it will recruit manufacturing personnel beginning in summer 2021.

Image: iStock/hernan4429

“The new facility gives Cytovia streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits,” said Robert Salcedo, president of BioSciencesCorp and acting head of Cytovia manufacturing.

“By operating multiple cell modular clean rooms and bioreactors scaled to 25 liters, the cGMP facility will provide best-in-industry capacity to support clinical and commercial operations. The facility has been designed to allow multi-product manufacturing, enabling Cytovia to produce iPSC-derived CAR NK therapeutics for thousands of patients and positioning it as a leading cell therapy company with full clinical and commercial manufacturing capabilities.”

The company genetically engineers Induced Pluripotent Stem Cells (iPSCs) to increase their capacity to both find and destroy cancer cells – adding Chimeric Antigen Receptors (CAR) if needed to give NK cells coordinates for their targets by binding only to specific proteins on chosen cancer cells.

The firm starts from a master bank of the engineered, but still-undefined stem cells, differentiate them into Natural Killer cells, and expands them. The cells can be used alone or with multi-specific antibodies developed by the firm.

Lead candidates are CYT-100, an allogeneic iPSC NK cell therapy and CYT-303, targeting hepatocellular carcinoma and solid tumors, with both hoping to enter the clinic by the end of the year and early 2022, respectively.

The news comes a month after Cytovia partnered with fellow cell and gene therapy firm Cellectis. The deal brings Cytovia access Cellectis’ TALEN gene-editing technology and could see Cytovia pay Cellectis up to $760 million in milestone and royalty payments for the first five TALEN gene-edited iPSC-derived NK products developed.