Kytopen, T-CURX, And The Fraunhofer IZI Establish Center Of Excellence To Develop Advanced, Non-Viral Cell Therapies

• Kytopen partners with T-CURX and the Fraunhofer Institute for Cell Therapy and Immunology (IZI) in Würzburg and Leipzig, Germany to establish a joint Center of Excellence (CoE) to engineer advanced cell therapies.
• T-CURX, a clinical-stage biotech company developing personalized immunotherapies, will contribute its expertise and proprietary transposon-based gene transfer technology.
• Process development through manufacturing scale-up will be led by teams at Fraunhofer IZI.
• The CoE aims to develop non-viral manufacturing workflows that remove key bottlenecks and accelerate delivery of lifesaving engineered cell therapies to patients worldwide.

Cambridge, MA and Würzburg, Germany and Leipzig, Germany /PRNewswire/ - Kytopen Corp., a leader in non-viral, continuous flow cellular engineering technologies, T-CURX GmbH ("T-CURX"), a leader in transposon-based CAR-T manufacturing, and Fraunhofer IZI, a developer of novel, clinically-relevant cellular therapies, today announced the establishment of a center of excellence (CoE). The CoE is designed to create an integrated discovery-to-manufacturing ecosystem that accelerates development timelines by combining best-in-class technologies with operational excellence to produce the highest quality cell therapies in the most cost-effective structure.

By integrating Kytopen's Flowfect® technology with T-CURX's proprietary transposon-based gene transfer system, the CoE aims to address key challenges in cell therapy scale-up, while enabling the rapid advancement of more potent and durable therapies into the clinic. Kytopen's continuous-flow transfection technology is designed for flexibility and scalability, seamlessly integrating into closed GMP workflows. Its gentle processing supports a broad range of cell therapy modalities. As part of the collaboration, the Flowfect Tx® platform will be installed on-site at Fraunhofer IZI to support the manufacturing of cell-based therapeutics. In addition, Fraunhofer IZI will gain access to the Flowfect Discover™ 96-well optimization platform to rapidly progress from proof-of-concept testing through process development optimization and into clinical and commercial manufacturing scale.

"This collaboration represents a next-generation approach to establishing advanced non-viral cell therapy processes at Fraunhofer IZI," said Prof. Dr. Michael Hudecek, Head of the Cellular Immunotherapy Branch at Fraunhofer IZI. "Our mission is to simplify and standardize the infrastructure required to develop advanced cell therapies through automation and streamlined logistics. The new Center of Excellence provides a strong foundation to realize this vision."

"The establishment of this Center of Excellence is a key pillar of Kytopen's strategy and a critical step in our commercialization efforts," said Kevin Gutshall, Chief Commercial Officer of Kytopen. "By aligning with leading technology innovators and manufacturing experts, we can deliver a true end-to-end solution with Flowfect® technology that expands access to transformative cell therapies for patients worldwide."

"We are excited to expand our collaboration with Kytopen and Fraunhofer IZI through this Center of Excellence," said Ulf Grawunder, Chief Executive Officer of T-CURX. "This partnership aligns with our mission to bring together industry leaders to develop non-viral, transposon-based CAR-T therapies that are more scalable and cost-effective—ultimately making these treatments more accessible to patients globally."

About the Collaboration
The Center of Excellence will serve as a hub for innovation in non-viral cell therapy development, focusing on scalable, efficient, and clinically robust manufacturing processes. By combining complementary expertise across technology development, translational research, and GMP manufacturing, the partners aim to accelerate the next generation of engineered cell therapies from bench to bedside.

About Kytopen:
The innovative leader in non-viral, continuous flow cellular engineering technologies, Kytopen, headquartered in Cambridge, Massachusetts, is transforming how cell therapies are manufactured by maximizing yields, delivering hundreds of billions of engineered cells in minutes – faster than any other technology – and thereby accelerating the discovery, development, and manufacture of advanced engineered cell therapies. Its Flowfect® cellular engineering technology is highly tunable, gentle on cells, and has demonstrated performance across a range of cell types, payloads, and therapeutic applications. Kytopen has recently disclosed strategic partnerships with industry-leading biotechnology companies, contract development and manufacturing organizations (CDMOs), and cell therapy-focused medical centers. Kytopen continues to engage strategic partners and is committed to enabling their partners' success by providing innovative technology and developing close collaborative relationships to bring lifesaving, next generation cell therapies to patients worldwide. www.kytopen.com

About T-CURX:
T-CURX GmbH ("T-CURX") is a private biopharmaceutical company focused on identifying, developing and commercialising next generation CAR-T cell therapies in cancer indications of high medical need. Based in Würzburg and Munich, Germany, the Company´s proprietary CAR-T technologies were developed in the labs of co-founder Professor Michael Hudecek at Universitätsklinikum Würzburg and are centered around a novel Sleeping Beauty ("SB") Transposon gene transfer technology, which is exclusively licensed to T-CURX.

T-CURX leverages several cutting-edge CAR-T engineering technologies, including virus-free transposon based genetic engineering and a highly flexible and modular CAR format. This provides unparalleled flexibility, efficacy, safety, but also scalability for developing CAR-T cells at significantly lower costs than conventional lentivirus-based CAR-T cell manufacturing. With an ambition to democratize transformative personalized CAR-T immunotherapies, T-CURX has a development pipeline of four CAR-T programmes.

For more information about T-CURX visit the website at www.t-curx.com

About Fraunhofer IZI:
The Fraunhofer Institute for Cell Therapy and Immunology (IZI) investigates and develops solutions to specific problems at the interfaces of medicine, life sciences and engineering. The Fraunhofer IZI develops, optimizes and validates methods, materials and products within the business units cell and gene therapy, drugs and vaccines, molecular diagnostics and immunodiagnostics, as well as extracorporeal therapies. Its areas of competency lie in cell biology, immunology, drug biochemistry, bioanalytics and bioproduction as well as process development and automation.

For more information about Fraunhofer IZI visit the website at www.izi.fraunhofer.de