Kiadis\nPharma has entered a definitive agreement to acquire US-based CytoSen\nTherapeutics, subject to Kiadis’ shareholder approval and customary closing\nconditions.<\/p>\n\n\n\n
Privately\nheld CytoSen has developed a proprietary natural killer (NK)-cell platform to\nenable NK-cell therapy with broad anti-cancer potential. It was founded on\ntechnology exclusively licensed from the University of Central Florida (UCF)\nand further developed at Nationwide Children’s Hospital (NCH). The company’s\nfounders, including Dean Lee, Stefan Ciurea and Robert Igarashi, are leading\nphysicians and scientists at NCH, MDACC and UCF, respectively. Following the\ntransaction, Dr. Carl June, a pioneer in the development of CAR T-cell therapy\nand current scientific advisor to CytoSen, will join Kiadis’ Scientific\nAdvisory Board.<\/p>\n\n\n\n
The\ntransaction creates a leader in cell-based cancer immunotherapy. The combined\ncompany has a complementary development pipeline focused on improving outcomes\nfor patients undergoing hematopoietic stem cell transplants (HSCT). Kiadis’\nlead T-cell product ATIR101 is in EU registration and a global Phase 3 clinical\ntrial; CytoSen’s lead NK-cell product\ncandidate, CSDT002-NK, building on promising clinical proof-of-concept studies\nin 25 patients carried out at MD Anderson Cancer Center, is expected to enter\nthe clinic in the US in 2020. The unique combination of proprietary and\nsynergistic NK-cell and T-cell therapy platforms has the potential to\nrevolutionize HSCT and enables Kiadis to create a pipeline with novel cancer\ntreatments.<\/p>\n\n\n\n
Arthur\nLahr, CEO of Kiadis commented: “Our\nvision is to leverage the strengths of the human immune system to help patients\nwith life-threatening diseases. With the addition of CytoSen, we can create\ncell therapy treatments that combine the innate and adaptive arms of the immune\nsystem. The ATIR T-cell and CSDT002-NK-cell programs each have the potential to\nmake transplants safer and more effective. In combination, they have the\npotential to revolutionize HSCT, making it suitable for an even wider group of\npatients. This transaction will transform Kiadis into a unique company with two\nsynergistic proprietary cell-based immunotherapy platforms and the opportunity\nto create a pipeline of innovative treatments for cancer patients<\/em>.”<\/p>\n\n\n\n Carl H.\nJune, MD, Richard W. Vague Professor in Immunotherapy in the Department of\nPathology and Laboratory Medicine at the University of Pennsylvania, commented:\n“NK-cell therapy could significantly\nadvance the field of immuno-oncology. Also, I believe the fields of NK-cells\nand T-cells are enormously synergistic and the combination could potentially\nhelp patients with devastating diseases. I am pleased to be joining the\nScientific Advisory Board of Kiadis<\/em>.”<\/p>\n\n\n\n Dean A.\nLee, MD, PhD, co-founder of CytoSen and director of the Cellular Therapy and\nCancer Immunology Program at Nationwide Children’s Hospital (NCH), commented:\n“CytoSen has the most advanced\nNK-cell technology to enable NK-cell therapy with broad anti-cancer potential.\nThe strong experience, infrastructure, and competencies of Kiadis in cell\ntherapy will accelerate our delivery of NK-cells to patients, and the new\nopportunities for exploring NK-cell and T-cell synergies will enable disruptive\ninnovation in the cell therapy space. I am excited to collaborate with Kiadis\nto bring this innovation to patients<\/em>.” <\/p>\n\n\n\n NK-cells\nare one of the body’s first lines of immunological defense with an innate\nability to rapidly and selectively destroy abnormal cells, such as cancer or\nvirally-infected cells. Advancing research into the biology of NK-cells, as\nwell as emerging early-stage clinical evidence, has increasingly shown that\nNK-cell immunotherapy has the potential to be at the forefront of cancer\nimmunotherapy. CytoSen’s patented nanoparticle processing technology enables\nimproved ex vivo expansion and activation of NK-cells supporting multiple high\ndose infusions with potent anti-cancer cytotoxicity.<\/p>\n\n\n\n CytoSen’s lead program, CSTD002-NK in HSCT, is built on proof-of-concept studies in 25 patients carried out at MDACC. First results of these studies demonstrated a relapse rate of 8% and progression-free survival (PFS) of 66% (published in Blood[1], with follow up data presented at the American Society of Hematology (ASH) annual meeting in 2018). The upcoming clinical study with CSDT002-NK, expected to start in 2020, has been designed with and will be supported by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The study will enroll high-risk acute myeloid leukemia (AML) patients undergoing a haploidentical HSCT at a consortium of leading US transplant centers in the BMT CTN network. Additionally, CytoSen’s NK-cell therapy will be investigated for other cancer treatments based on an 8-patient proof-of-concept study conducted at MDACC in refractory AML.<\/p>\n\n\n\n