Kytopen Enables Significant Advances in Non-viral Cellular Engineering of Monocyte-derived Macrophages

• Successful engineering of macrophages is of critical importance for next-generation immunotherapies, including solid tumors.
• Kytopen optimization study using the Flowfect Discover™ 96-well platform demonstrated >90% gene delivery efficiency and viability of monocyte-derived macrophages.
• A single, optimized protocol was transferred to commercial scale on the Flowfect Tx™ GMP platform in less than three weeks.

CAMBRIDGE, Mass., Oct. 22, 2024 /PRNewswire/ -- Kytopen Corp., a leader in providing non-viral, continuous flow cellular engineering technologies, today announced the successful completion of a pivotal cellular engineering study that achieved high transfection rates and yields of healthy monocyte-derived macrophages using its Flowfect^® technology platforms. The study was conducted in a two-phased approach, whereby, in the first phase, a multi-parameter optimization study was performed with the Flowfect Discover™ 96-well platform to determine the optimal gene delivery profile, followed by the scale up of the optimized protocol with the Flowfect Tx™ GMP-ready system to confirm parity at scale. In support of a prospective customer as part of the Technology Access Program ("TAP"), the study exceeded customer expectations and specifications by achieving more than 90% efficiency and viability in less than three weeks of initiation of experiments.

Considered the master orchestrators of the immune system, macrophages are key players in initiating and maintaining immune response in multiple disease areas and specifically within the tumor microenvironment. Accordingly, engineered macrophages have the potential to provide an even more potent and durable immunomodulatory, anti-inflammatory, and regenerative response in cell therapy. The ability to manipulate their function via gene delivery is thus of great interest. However, monocyte-derived macrophages are notoriously difficult to transfect, and conventional gene delivery systems have failed to deliver commercially relevant numbers of engineered cells due to significant loss of cells, low transfection efficiency, low viability, and challenges to scale.

"Unlike other cell types, macrophages have been shown to be present in most human tumors. As such these cells hold the potential to become powerful engineered cell therapies," said Kevin Gutshall, Chief Commercial Officer of Kytopen, "With our Flowfect^® technology, cell therapy developers have a tool that can effectively deliver genes to challenging cell types for the development of advanced cell therapies to treat cancer, autoimmune diseases, and other debilitating diseases. We are committed to serving our partners in their pursuit to advance the frontier of immunotherapy by enabling the development of transformative therapies more rapidly and cost effectively for patients worldwide."

A highly tunable system, Flowfect^® technology 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. By balancing the influence of multiple parameters, Flowfect^® technology provides an optimal gene delivery process that is gentle on cells, while continuous flow enables the processing of liters of material to produce hundreds of billions of healthy, high-quality engineered cells in a closed, automated system in just minutes.

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 continuous 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]

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SOURCE Kytopen