CytoSen Therapeutics and KBI Biopharma announced a strategic partnership to manufacture therapeutic Natural Killer (NK) cells using a proprietary and scalable, closed system manufacturing process. As part of the initial collaboration, KBI will manufacture the NK cell product in its The Woodlands, Texas facility for CytoSen’s planned Phase 2 trial evaluating lead candidate CSTD002-NK in high risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT), expected to begin the first half of 2019. KBI will also manufacture CytoSen’s proprietary nanoparticles used in the expansion of the NK cell product.
KBI is a leading biopharmaceutical contract services company providing fully integrated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. To date, the company has served more than 300 clients around the world, including most of the top 10 pharmaceutical companies.
“This is an important milestone for CytoSen as it reinforces our team’s strategic vision and commitment to accelerate innovation and access to NK cell therapies,” said Robert Igarashi, Ph.D., Co-founder and CSO of CytoSen. “KBI’s deep expertise and broad capabilities including commercial biopharmaceutical manufacturing of therapeutic proteins and cell therapy services enable advanced, high quality development of CytoSen’s pipeline candidates, including CSTD002-NK as it enters the proposed Phase 2 trial, our first clinical study utilizing the nanoparticle technology.”
“We’re very excited to collaborate with CytoSen and leverage their pioneering technology, combined with our extensive experience in process development, to deliver these promising NK cell therapies to patients in need,” said Tim Kelly Ph.D., President and CEO of KBI. “KBI is uniquely suited to partner with CytoSen to advance these innovative programs as we draw on expertise from sites across our network in Texas, North Carolina, and Colorado to support robust scalable NK cell drug product manufacturing, nanoparticle production, and analytical characterization of these specialized materials.”
CytoSen’s unique nanoparticle processing technology, which is based on an exclusive license from University of Central Florida, leverages nanoparticles to present membrane-bound ligands which stimulate growth of NK cells to high cell densities in disposable closed manufacturing systems.