Implementing scalable manufacturing processes to enable cGMP production of investigational Natural Killer cell therapies
Dallas, TX and Durham, NC – October 2, 2018 – CytoSen Therapeutics and KBI Biopharma today 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.
About CytoSen’s NK Cell Platform
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 nanoparticle processing 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 lead product, CSTD002-NK, is poised to enter Phase 2 clinical studies in the U.S. in the first half of 2019 as a best-in-class NK cell therapy for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in HSCT patients.
CytoSen’s technology platform is based on the work of Dean Lee, M.D., Ph.D., 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, M.D., Associate Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Data from Phase I/II clinical trials at MDACC demonstrated compelling results in treating AML.
About KBI Biopharma, Inc.
KBI Biopharma is a biopharmaceutical Contract Development & Manufacturing Organization driven to accelerate the development of innovative discoveries into life-changing biological products and expand global access of medicines to patients in need.
From early-stage biotech to academic/non-profit organizations to many of the world’s largest pharmaceutical companies, KBI has served more than 300 clients globally to accelerate and optimize their drug development programs.
KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques towards the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapies for our clients.
KBI was founded in 1996 and operates facilities in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), San Diego (CA), and Leuven, Belgium.
About CytoSen Therapeutics, Inc.
CytoSen is a private biopharmaceutical company on the front line of advancing clinical development of next generation NK cells with the first scalable, therapeutic platform for high dose, cancer-killing NK cells calibrated to each cancer target while reinforcing immune defenses.
Born from the intersection of cellular immunotherapy and nanotechnology, CytoSen’s NK cell therapy harnesses the power of the immune system to treat cancer.
Learn more about CytoSen at www.CytoSen.com/.