Kiadis Pharma announces U.S. FDA approval to start NK-REALM Phase 2 clinical trial for natural killer (NK) cell therapy produced with PM21
- Category: DNA RNA and Cells
- Published on Wednesday, 06 May 2020 10:05
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FDA approval of Investigational New Drug (IND) application supports the Company’s planned NK-REALM Phase 2 study which will evaluate K-NK002 in 63 patients with blood cancer undergoing a haploidentical hematopoietic stem cell transplant (HSCT)
AMSTERDAM, The Netherlands I May 6, 2020 I Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announced that it 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.
Kiadis’ Phase 2 study, called NK-REALM (haploidentical NK-cells to prevent post-transplant RElapse in AML and MDS), will evaluate the use of K-NK002 as an adjunctive therapy for blood cancer patients undergoing a haploidentical HSCT with the current standard of care, the post-transplant cyclophosphamide (PTCy) protocol. The study, which will be conducted with the NIH-supported Blood and Marrow Transplant Clinical Trials Network (BMT CTN), funded by the National Heart, Lung and Blood Institute and the National Cancer Institute, both part of the National Institutes of Health (NIH), will enroll 63 patients at leading transplant centers in the U.S. The first 6 patients in the NK-REALM study will be evaluated as a safety lead-in. The study is designed to confirm earlier proof-of-concept data in 24 patients, which showed that adjunctive treatment with K-NK002 has the potential to substantially improve outcomes for patients in need of a HSCT.
The Company’s phase 2 study will evaluate K-NK002 produced using Kiadis’ proprietary PM21 technology platform that enables high dose, low cost, scalable and industrial production of NK-cell therapy without the risk of residual tumor cells in the final product. This is the first human trial using drug produced with Kiadis’ PM21 technology. Kiadis is able to proceed directly with a phase 2 trial based on bridging from K-NK cells produced with FC21 used in earlier clinical studies to K-NK cells now produced with PM21.
Arthur Lahr, CEO of Kiadis Pharma, commented, “The rapid approval of the IND that allows us to initiate this phase 2 clinical trial is an important step forward for Kiadis in bringing K-NK cell therapy to patients in need. This study is the first with K-NK cells produced with our PM21 particle production platform. Our ability to proceed directly with a Phase 2 leverages existing clinical data and further validates similarity between K-NK cells produced with FC21 and PM21. We will now work with BMT CTN to start the study and expect to enroll the first patients in the safety lead in this year.”
About Kiadis Pharma’s K-NK-Cell Therapies
Kiadis Pharma’s K-NK platform is designed to deliver potent NK cells to help patients, without the need for genetic engineering. Kiadis Pharma’s programs consist of off-the-shelf and haploidentical donor NK-cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.
The Company’s PM21 particle technology enables improved ex vivo expansion and activation of cytotoxic NK cells supporting multiple high-dose infusions. Kiadis Pharma’s proprietary off-the-shelf NK-cell platform is based on NK cells from unique universal donors and can make NK-cell therapy product rapidly and economically available for a broad patient population across a wide range of indications.
Kiadis Pharma is developing K-NK002 as an adjunctive immunotherapeutic on top of HSCT, and K-NK003 for the treatment of relapse/refractory acute myeloid leukemia. In addition, Kiadis Pharma has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.
About Kiadis Pharma
Founded in 1997, Kiadis Pharma is building a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and activities across the United States, Kiadis Pharma is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.
Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.
About BMT CTN
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to 41 Phase 2 and 3 trials at more than 100 transplant centers and enrolled over 11,600 study participants.
The BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both part of the National Institutes of Health (NIH), and is a collaborative effort of 20 Core Transplant Centers/Consortia, The Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP)/Be The Match, and the Emmes Company, LLC, a clinical research organization. CIBMTR is a research collaboration between the NMDP/Be The Match and the Medical College of Wisconsin.
More information about the BMT CTN can be found at www.bmtctn.net.
SOURCE: Kiadis Pharma