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NKCell Firm Cytovia Therapeutics Announced The Opening of New Boston R&D Center of Excellence & cGMP Manufacturing Facility

By John F. Heerdink, Jr.
Chimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity, or Graft vs Host Disease (GVHD). In addition, CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the induced pluripotent stem cell (iPSC)-derived CAR-NKs, allow large quantities off-the-shelf, homogeneous CAR NK cells to be produced from a gene-edited iPSC master cell bank, and thus hold promise to expand access to cell therapy for many patients.

On March 17, 2021  Cytovia Therapeutics, Inc., 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, announced two agreements for R&D and manufacturing operations in Massachusetts and Puerto Rico that will accelerate the company’s Universal iPSC NK cells towards clinical trials beginning in Q4 2021 and gene-edited iPSC CAR-NK cells by 2022.

The firs agreement has enabled Cytovia to move into state-of-the-art laboratory space at the ABI-LAB facility in Natick, MA in March. Cytovia has also 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.

In a parallel investment, Cytovia signed a long-term joint collaboration manufacturing and operations agreement with BioSciencesCorp to integrate Cytovia’s manufacturing processes within an existing 95,000 ft2 cGMP facility, including more than 40,000 ft2 of clean-room and biomanufacturing, located in Aguadilla, Puerto Rico. The company will recruit manufacturing personnel beginning in summer 2021.


Wei Li, Chief Scientific Officer of Cytovia Therapeutics

“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, Chief Scientific Officer 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.

Robert Salcedo, the president of BioSciencesCorp and acting head of Cytovia manufacturing

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, the 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.”

Raphael Nir, PhD, Co-Founder, Managing Partner and CSO of ABI-LAB commented,

“We are delighted to welcome Cytovia Therapeutics to the Boston biotech ecosystem. Cytovia brings some of the most advanced R&D capabilities in cell therapy and antibody development, with vast potential to provide a breakthrough anti-cancer treatment. We are thrilled to be part of this important journey and will provide any help to expedite Cytovia development efforts towards clinical trials.” stated Raphael Nir, PhD, Co-Founder, Managing Partner and CSO of ABI-LAB commented,

About Cytovia Therapeutics
Cytovia aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on Natural Killer (NK) cell biology and applies precision engineering to induced pluripotent stem cells (iPSCs) to develop the safest, most effective, most broadly-available Natural Killer cell therapy as a first line of defense against cancer. Cytovia’s proprietary multi-specific antibody platform has been customized to engage and activate NK Cells at the tumor site. Both platforms offer optionality to clinicians and can also be used synergistically. Cytovia’s R&D laboratories and GMP manufacturing facility are augmented by scientific partnerships with Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, STC Biologics, and the University of California San Francisco (UCSF). Learn more at www.cytoviatx.com Cytovia Therapeutics.

ABI-LAB – Accelerator and Bioincubator Lab in Natick, MA supports startup companies through availability of affordable lab space and innovative pre-clinical services. ABI-LAB collaborates with entrepreneurs throughout their journey to resolve unmet medical needs. The campus consists of two first-class buildings that offer best-in-class infrastructure and state-of-the-art lab space that range in size from 500 to 4,000 square feet. In its 5th year of operation, ABI-LAB currently houses over 32 biotechnology companies. The Innovation Lab at ABI-LAB is home to over 20 unique instruments, and is available at no additional cost to residents to use. The equipment list is including FACS (Attune), Luminex 2000, QuantStudio 6 Pro, EVOS M700 and more. The campus provides a place to share space with like-minded individuals, shared amenities, and experienced industry leaders who can guide residents to bring early scientific discoveries to fruition.

About BioSciencesCorp
BioSciencesCorp is a provider of end-to-end biologics and cell therapy manufacturing operation partnering with ambitious biotechnology companies to bring programs though cGMP development to market. BioSciencesCorp will manage Cytovia’s manufacturing site and process and oversee the technical transfer, additional process development associated with scale-up, and provide support their commercial production. BioSciencesCorp, led by Robert Salcedo and Daniel Chang, is implementing commercial-scale gene and cell therapy, cGMP viral production, and biosimilars. Full cGMP operations are planned for Q4 2021.

We have made another investment in called Cytovia Therapeutics that some investors are calling “FATE 2.0”. They are seeking to go public Q2/Q32021. Learn more at the Cytovia website is www.cytoviatx.com.

(Read Original Story: Cytovia Therapeutics Opens Boston R&D Center of Excellence and Announces cGMP Manufacturing Facility, Aiming to Start Clinical Trials for its Gene-Edited iPSC CAR-NK Cells by 2022 in Cytovia Therapeutics, Inc.)