Kytopen FlowFect™ Platform to Be Used in GMP-Manufacture of an Engineered Cell Therapy - IND Submission and Clinical Study in 2024

• Kytopen announces the first implementation of its GMP-compliant Flowfect Tx™ cellular engineering platform.
• GMP Manufacturing of non-viral engineered cells at clinical and commercial levels has been validated externally by this commercial partner.
• The Flowfect Tx™ technology has a Drug Master File ("DMF") on file with the U.S. Food and Drug Administration ("FDA") in support of its use in GMP manufacturing.
• Kytopen is uniquely positioned to transform how engineered cell therapies are manufactured by maximizing yields, delivering hundreds of billions of engineered cells in minutes – faster than any other technology.

CAMBRIDGE, Mass., July 16, 2024 /PRNewswire/ -- Kytopen Corp., a leader in providing non-viral, continuous flow cellular engineering technologies, today announced the successful sale and installation of its Flowfect Tx™ clinical- and manufacturing-scale transfection system to a leading, publicly traded, cell therapy company that is pioneering the development of advanced CAR T-cell therapies. Prior to its purchase, the undisclosed client completed an extensive proof of concept process development with the Flowfect™ technology as one of Kytopen's first Technology Access Program ("TAP") partners. This clinical-stage biotechnology innovator anticipates the submission of an investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its lead asset for the treatment of autoimmune diseases in the fourth quarter of 2024.

A highly tunable system, The Flowfect™ platform is unique in that it combines mechanical, electrical, and chemical forces, and allows the adjustment of multiple parameters to maximize transfection efficiency, cell health, and cell yield. As a premier TAP partner, this customer leveraged direct support from Kytopen's specialized Field Applications Team, the Flowfect Discover™ 96-well optimization platform, and the Flowfect Tx™ GMP-ready system to progress from proof-of-concept testing through process development optimization and into clinical and commercial manufacturing scale in an accelerated program within just two weeks.

The Flowfect Tx™ system is a critical extension of the customer's arsenal of proprietary technologies. By balancing the influence of multiple mechanical and electrical parameters, the Flowfect™ technology provides an optimal gene delivery process, while continuous flow enables the processing of liters of material to produce hundreds of billions of healthy, high-quality engineered cells in just minutes. This addresses the primary challenges in the manufacture of advanced cell therapies, namely the need to generate large numbers of healthy engineered cells in a closed, automated system.

"We are thrilled to announce the success of our partners with the Flowfect Tx™ system as it represents an opportunity for cell therapy developers to acquire a truly differentiated technology that maximizes yields of edited cells." said Dr. Michael Chiu, Chief Executive Officer at Kytopen. "We are committed to leading the way in helping the industry accelerate development and address the challenges in the manufacture of advanced cell therapies. This is the first of many applications in our pipeline and we are eager to partner with therapeutic companies worldwide."

Kytopen's Flowfect™ non-viral cellular engineering platform has demonstrated performance across a range of cell types, payloads, and therapeutic applications. The Company is also collaborating with leading development partners who are using the Flowfect™ technology for emerging therapeutic products and delivery platforms, including extracellular vesicle ("EV")- and lipid nanoparticle ("LNP")-based therapies.

About Kytopen

Kytopen, headquartered in Cambridge, Massachusetts with an R&D site in Denver, Colorado, is a leading biotechnology company specializing in the development and commercialization of non-viral continual flow cellular engineering platforms to accelerate the processes of discovery, development, and the manufacture of advanced engineered cell therapies  In 2023, Kytopen unveiled the Flowfect Discover™ 96-well platform, an automated high-throughput system for the optimization of genome engineering, and disclosed strategic partnerships with industry-leading contract development and manufacturing organizations (CDMOs) and cell therapy-focused medical centers. By combining the Flowfect Discover™ platform with the large-scale manufacturing Flowfect Tx™ system in process development workflows, cell therapy developers overcome manufacturing challenges, fostering swifter and more cost-effective innovation. https://www.kytopen.com/

Investor Contact:

Michael Chiu PhD., CEO
[email protected]

Business and Corporate Development Contact:
Kevin Gutshall, CCO
[email protected]

SOURCE Kytopen