Kiadis Pharma has received approval from the U.S. Food and Drug Administration (FDA) to start its NK-REALM phase 2 clinical trial, which the Company submitted through an investigational new drug (IND) application in April 2020. Kiadis is developing K-NK002 as an adjunctive therapy to the haploidentical HSCT standard of care with the goal of reducing relapse rates.<\/p>\n\n\n\n
Kiadis\u2019 Phase\n2 study, called NK-REALM (haploidentical NK<\/strong>-cells to prevent post-transplant RE<\/strong>lapse in A<\/strong>ML<\/strong> and M<\/strong>DS), will evaluate\nthe use of K-NK002 as an adjunctive therapy for blood cancer patients\nundergoing a haploidentical HSCT with the current standard of care, the\npost-transplant cyclophosphamide (PTCy) protocol. The study, which will be\nconducted with the NIH-supported Blood and Marrow Transplant Clinical Trials\nNetwork (BMT CTN), funded by the National Heart, Lung and Blood Institute and\nthe National Cancer Institute, both part of the National Institutes of Health\n(NIH), will enroll 63 patients at leading transplant centers in the U.S. The first\n6 patients in the NK-REALM study will be evaluated as a safety lead-in. The\nstudy is designed to confirm earlier proof-of-concept data in 24 patients,\nwhich showed that adjunctive treatment with K-NK002 has the potential to\nsubstantially improve outcomes for patients in need of a HSCT.<\/p>\n\n\n\n The Company\u2019s\nphase 2 study will evaluate K-NK002 produced using Kiadis\u2019 proprietary PM21\ntechnology platform that enables high dose, low cost, scalable and industrial\nproduction of NK-cell therapy without the risk of residual tumor cells in the\nfinal product. This is the first human trial using drug produced with Kiadis\u2019\nPM21 technology. Kiadis is able to proceed directly with a phase 2 trial based\non bridging from K-NK cells produced with FC21 used in earlier clinical studies\nto K-NK cells now produced with PM21. <\/p>\n\n\n\n Arthur Lahr,\nCEO of Kiadis Pharma, commented, \u201cThe rapid approval of the IND that allows us\nto initiate this phase 2 clinical trial is an important step forward for Kiadis\nin bringing K-NK cell therapy to patients in need. This study is the first with\nK-NK cells produced with our PM21 particle production platform. Our ability to\nproceed directly with a Phase 2 leverages existing clinical data and further\nvalidates similarity between K-NK cells produced with FC21 and PM21. We will\nnow work with BMT CTN to start the study and expect to enroll the first\npatients in the safety lead in this year.\u201d<\/p>\n\n\n\n