C200 schreef op 9 april 2020 08:31:
Kiadis Pharma files first investigational new drug application with the U.S. FDA for natural killer (NK) cell therapy produced with PM21
Kiadis Pharma files first investigational new drug application with the U.S. FDA for natural killer (NK) cell therapy produced with PM21
IND supports the Company’s planned NK-REALM Phase 1/2 study which will evaluate K-NK002 in 63 patients with blood cancer undergoing a haploidentical hematopoietic stem cell transplant (HSCT)
Amsterdam, The Netherlands, April 9, 2020 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announced that is has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the Company’s natural killer cell therapy product K-NK002. The IND covers the production of K-NK002 using Kiadis Pharma’s 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. The Company plans to initiate a Phase 1/2 study with leading transplant centers in the U.S. to evaluate K-NK002 once it receives FDA approval for the IND.
Kiadis Pharma is developing K-NK002 as an adjunctive therapy to the current haploidentical HSCT standard of care with the goal of improving relapse rates. The Phase 1/2 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, post-transplant cyclophosphamide (PTCy) protocol. The study, which will be conducted with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), will enroll 63 patients at leading transplant centers in the U.S. 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 HSCT.
Arthur Lahr, CEO of Kiadis Pharma, commented, “The filing of this IND is an important step forward for Kiadis in bringing K-NK cell therapy to patients in need. Under normal circumstances, the FDA would take 30 to 60 days to review an IND, but given the current environment it is difficult to project a date for IND approval. Once approved, we are ready to immediately initiate the trial with the BMT CTN, and ramp up production of clinical materials.”
About Kiadis Pharma’s K-NK-Cell Therapies
Kiadis Pharma’s K-NK platform is designed to deliver potent NK cells to help each patient, 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 potentially wide range of indications.
Kiadis Pharma is developing K-NK002, which is administered 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 offices 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 II and III 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.