CAMBRIDGE, Mass.– August 13, 2024 – Kytopen Corp., a leader in providing non-viral, continuous flow cellular engineering technologies, today announced that the Allergy and Infectious Diseases Research program of the National Institutes of Health (“NIH”) has awarded Kytopen a competitive Phase II Small Business Innovation Research (“SBIR) Fast-Track grant of $1.6 million after the successful completion of its Phase I funding titled “Non-Activated Natural Killer (“NK”) Cell Engineering for Enhanced Cytotoxic Potential”. The SBIR grant continuation will be spread over two years as research milestones are successfully completed. A key aim of this work includes in vivo preclinical studies. Charles River Laboratories, a premier cell and gene therapy CDMO leader, will be commissioned by Kytopen to conduct the in vivo preclinical studies to validate the large-scale production and enhanced efficacy of Flowfect™ engineered-NK cell therapies.
Exhibiting a safer profile, more efficient anti-tumor activity, and with fewer adverse events overall, having the advantage to become off-the-shelf products, NK cells have the potential to overcome many of the limitations of current CAR-T cell therapies. Genetic manipulation will enable an even greater improvement of NK-cell persistence, anti-tumor function, and tumor targeting to deliver more-effective next-generation cellular therapies. However, NK-cell engineering still faces technical challenges, including the difficulty of gene delivery while maintaining cell health.
“Conventional gene delivery technologies fall short in their ability to engineer NK cells, largely due to their low gene-editing rates and high cell damage among other challenges” said John Zhao, Head of Science at Kytopen. “The Flowfect Tx™ platform allows for the adjustment of multiple parameters to maximize transfection efficiency, cell health, and cell yield.”
A highly tunable system, by balancing the influence of multiple mechanical and electrical parameters, the Flowfect Tx™ platform delivers genes in a gentle, effective manner while continuous flow enables the processing of liters of material to produce hundreds of billions of healthy, high-quality engineered cells. The NIH funding will be used to highlight these features; the speed and volume at which the Flowfect Tx™ platform can be used to manufacture the highest quality cellular drug products.
“We are honored to be presented such a prestigious and competitive award,” said Kevin Gutshall, Chief Commercial Officer at Kytopen. “Phase II of our engineered-NK cell program will allow us to generate in vivo data focused on improving the efficacy and yields needed to commercialize non-viral engineered NK cells. We believe this preclinical data will accelerate the advancement of engineered NK-cell therapies into the clinic to make the next generation of cell therapies available to patients worldwide, and together with our commercial strategy, Kytopen will revolutionize engineered cell therapies.”