Kiadis Pharma files first investigational new drug application with the U.S. FDA for natural killer (NK) cell therapy produce...
09 Abril 2020 - 3:30AM
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 PharmaFounded 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 CTNThe 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.
Kiadis Pharma Contacts:
Kiadis Pharma:
Maryann Cimino, Sr. Manager, Corporate AffairsTel: +1 (617)
710-7305m.cimino@kiadis.com |
Optimum Strategic
Communications:Mary Clark, Supriya Mathur, Hollie VileTel:
+44 203 950 9144David Brilleslijper (Amsterdam)Tel: +31 610 942
514kiadis@optimumcomms.com |
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect Kiadis Pharma’s or, as appropriate,
Kiadis Pharma’s officers’ current expectations and projections
about future events. By their nature, forward-looking statements
involve a number of known and unknown risks, uncertainties and
assumptions that could cause actual results, performance,
achievements or events to differ materially from those expressed,
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outcome and financial effects of the plans and events described
herein. A multitude of factors including, but not limited to,
changes in demand, regulation, competition and technology, can
cause actual events, performance, achievements or results to differ
significantly from any anticipated or implied development.
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regarding past trends or activities should not be taken as a
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obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or projections, or any change in events,
conditions, assumptions or circumstances on which these
forward-looking statements are based. Neither Kiadis Pharma nor its
advisers or representatives nor any of its subsidiary undertakings
or any such person’s officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
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