NewBiologix Licenses Florabio's HEK293 Cell Line for the Generation of Novel and Proprietary Cell Lines for the Stable Expression of rAAVs used in Gene Therapy

NewBiologix SA, a technology innovation company focused on addressing gene therapy manufacturing gaps, announced today a licensing agreement with Florabio AS, a global leader specialized in developing cell lines and chemically defined cell culture media, to genetically engineer their proprietary HEK293 cell line for the stable production of recombinant adeno-associated virus (rAAV) vectors used in gene therapy. NewBiologix's innovative approach stands to replace the industry-standard transient transfection methods, offering a stable, more reliable, and scalable solution for biopharmaceutical companies developing gene therapies.

Under the terms of the agreement, NewBiologix acquired rights to use Florabio's HEK293 suspension cell line for research and commercial applications. Leveraging proprietary genomic data, NewBiologix plans to engineer the Florabio HEK293 cell line and select highly characterized clones with exceptional growth, expansion, and transfectability properties.

Igor Fisch, Ph.D., NewBiologix CEO and Co-founder, said: "NewBiologix's founding mission is to help biopharmaceutical companies develop and manufacture cutting-edge gene therapies that are safer, more effective and at scale. Our engineered HEK293 cell line will be foundational for us to help our customers deliver population-scale manufacturing to patients in need by maximizing the production of safer and functional vectors."

The HEK 293 cell line has been key in advancing gene therapies. Suspension-adapted HEK293 cells are used for commercial AAV production. In a suspension-based process, the cells grow at high cell densities in a serum-free medium, enabling higher volumetric yields. However, developing a serum-free suspension HEK293 platform is challenging primarily due to the current triple transfection methods, which impact scalability, titers, and batch-to-batch variability.

NewBiologix has set itself to meet the demand for gene therapy clinical trials and commercial applications by engineering HEK293 cell lines that will increase productivity at the cellular and volumetric levels while improving batch-to-batch consistency, product purity, and potency.

Cem Erdem, Founder and Chief Executive Officer of Florabio, said: "We share NewBiologix's mission in helping biopharmaceutical companies produce gene therapies in shorter time and more cost efficient by delivering scalable solutions. NewBiologix will achieve its goals faster and more efficiently by starting with the 'FlorabioHEK293' cell line and our chemically defined HEK293 medium."

ABOUT NEWBIOLOGIX

Based in Lausanne, Switzerland, NewBiologix SA is a technology innovation company focused on developing a proprietary and breakthrough DNA integration platform for the advanced engineering of cells lines for the generation and production of viral vectors used in gene and cell therapies. By combining an innovative and proprietary bioinformatics platform with advanced R&D experimentation, the company's mission is to help biopharmaceutical companies develop transformative gene therapies faster, safer and at scale. Learn more at www.newbiologix.com.

ABOUT FLORABIO

Florabio is a life science company with proprietary technology, know-how, and experience in manufacturing therapeutic proteins in the shortest time with the most economic measures. Florabio's platform technologies for vaccine and recombinant protein production provide our clients with industrial usage-ready production cells, 100% chemically defined culture media, and ready-to-use processes. Our platforms consider all aspects of manufacturing while developing the process such as IP, regulation, scalability, and robustness. In this way, we offer a holistic approach to our clients to reach the market faster, easier, and more scalable. Florabio's latest development offers the first and only platform in the market for optimization of glycosylation through culture media modification. For more information visit www.florabio.com.tr.