Cytovia Therapeutics, a biopharmaceutical company developing allogeneic “off-the-shelf” gene-edited chimeric antigen receptor (CAR)-NK cells derived from induced pluripotent stem cells (iPSCs) and NK-engager bispecific antibodies, entered into two agreements for R&D and manufacturing operations in Massachusetts and Puerto Rico. The deals are intended to accelerate the company’s universal iPSC NK cells towards clinical trials beginning in Q4 2021 and gene-edited iPSC CAR-NK cells by 2022.
Cytovia will move into new lab space at the ABI-LAB facility in Natick, MA, this month, and has started recruiting R&D and process development personnel to its existing team. Cytovia’s existing cell therapy operation under the New York Stem Cell Foundation and antibody GMP manufacturing with STC Biologics will continue.
Cytovia also signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000-sq-ft cGMP facility, including more than 40,000-sq-ft of clean-room and biomanufacturing, located in Aguadilla, Puerto Rico. The company will recruit manufacturing personnel beginning in summer 2021.
“We’re excited to rapidly expand our R&D team with the best talent in the Boston area. The combination of advanced laboratory space and cost-effective cGMP manufacturing capability represents a highly significant milestone as Cytovia’s NK off-the-shelf cell therapies and bispecific products accelerate towards the market,” said Wei Li, CSO of Cytovia Therapeutics. “The integration of Cytovia’s two new facilities is designed to allow the company to take each of our products rapidly and seamlessly into clinical and commercial production.”
The Natick laboratories will comprise four activities: NK cell biology, gene-editing, antibody and CAR development, and NK cell pilot manufacturing. The NK cell technology will then transfer directly to larger-scale but matching production operations in Puerto Rico.
Cytovia’s first cell product is scheduled to be in the clinic in 2021 with up to three additional CAR-NK cell products following in 2022.
“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,” noted Robert Salcedo, the president of BioSciencesCorp and acting head of Cytovia manufacturing.
“By operating multiple cell modular clean rooms and bioreactors scaled to 25 L, 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.”
“We are delighted to welcome Cytovia Therapeutics to the Boston biotech ecosystem,” added Raphael Nir, PhD, co-founder, managing partner, and CSO of ABI-LAB. “Cytovia brings some of the most advanced R&D capabilities in cell therapy and antibody development, with vast potential to provide a breakthrough anticancer treatment. We are thrilled to be part of this important journey and will provide any help to expedite Cytovia development efforts towards clinical trials.”