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In tandem for therapeutic Natural Killer cells
Dallas, TX and Durham, NC—CytoSen Therapeutics and KBI BioPharma have agreed upon a strategic partnership to manufacture therapeutic Natural Killer (NK) cells, using a proprietary and scalable closed system manufacturing process. As part of their 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 in the first half of 2019. KBI will also manufacture CytoSen’s proprietary nanoparticles, which are used in the expansion of the NK cell product.
“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, PhD, 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.”
NK cells play a significant role in the body’s innate immune response, circulating through the body to rapidly recognize and kill cancerous cells. CytoSen’s unique nanoparticle processing technology, based on an exclusive license from the 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. The technology enables improved and sustained growth of high-dose NK cells that have high anti-cancer cytotoxicity, as well as increased expansion and activation capabilities.
CytoSen’s technology platform is based on the work of Dean Lee, MD, PhD, Director of the Cellular Therapy and Cancer Immunotherapy Program for Nationwide Children’s Hospital’s Division of Hematology/Oncology/BMT and Center for Childhood Cancer and Blood Diseases, and Stefan Ciurea, MD, Associate Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center (MDACC). Data from Phase I/II clinical trials at MDACC demonstrated compelling results in treating AML.
“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, PhD, 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.”