Kiadis Pharma announces FDA clearance of clinical study by The Ohio State University in R/R AML with off-the-shelf NK cells f...
26 Fevereiro 2020 - 4:30AM
Kiadis Pharma announces FDA clearance of clinical study by The Ohio
State University in R/R AML with off-the-shelf NK cells from
universal donors
Amsterdam, The Netherlands, February 26,
2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext
Amsterdam and Brussels: KDS), a clinical stage
biopharmaceutical company, and The Ohio State University - Arthur
G. James Cancer Hospital and Richard J. Solove Research Institute
(“OSU” or “OSUCCC-James”), today announced the launch of a
first-in-human clinical trial in patients with relapsed/refractory
acute myeloid leukemia (R/R AML) with off-the-shelf Natural Killer
(“NK”) cells manufactured using Kiadis’ FC21 mbIL21 feeder cells
and proprietary universal donor platform. The trial is expected to
provide further clinical proof-of-concept of Kiadis’ K-NK003
product.
The investigator-sponsored trial will be
conducted at OSUCCC – James, a National Cancer Institute
(NCI)-designated comprehensive cancer center and freestanding
cancer hospital located in Columbus, Ohio, in the United States.
The OSUCCC – James team received Food and Drug Administration (FDA)
approval for an investigational new drug application to begin this
trial and expects to begin enrolling patients in March 2020. Kiadis
will support the study through a collaborative research agreement
with OSUCCC-James. Additionally, OSU and Kiadis plan to work
together to initiate a company sponsored trial with off-the-shelf
K-NK003 cells expanded with Kiadis’ particle production platform
(PM21) in the same patient population later this year.
The study entitled “A Phase I Clinical Trial
Testing the Safety of IL-21-Expanded, Off-the-shelf, Third-party
Natural Killer Cells for the Induction of Relapsed/Refractory Acute
Myeloid Leukemia and Myelodysplastic Syndrome” will evaluate the NK
cell product in up to 56 patients, ages 18 – 80 who have primary
refractory AML, relapsed AML, or myelodysplastic syndromes (MDS).
The goal of this study is to establish safety of the NK cell
therapy for the induction of remission in patients with
Relapsed/Refractory (“R/R”) AML or MDS and to determine the optimal
dosing and overall response rate. Patients enrolled in the study
will receive six doses of NK cells of 1 x 107 cells/kg to 1 x 108
cells/kg after receiving reinduction chemotherapy.
“NK cells given outside the setting of
transplantation have shown to induce remissions.
Relapsed/refractory AML and MDS patients have a high chance of
progression while waiting for manufacturing of expanded
directed-donor NK cells, so having an easily accessible product,
and one that does not require administration of cytokines, may be
an attractive approach for these patients,” stated Sumithira Vasu,
MBBS, a hematologist scientist and Medical Director of the Cell
Therapy Lab at OSUCCC - James who will serve as principal
investigator of the clinical trial. Vasu is also an associate
professor at The Ohio State University College of Medicine. “This
trial uses a novel off-the-shelf, readily available product to
treat what is traditionally a very sick and difficult-to-treat
group of patients. I look forward to the collaboration with Kiadis
to help accelerate development of this cell therapy.”
“We are very pleased to be working with OSU and
Dr. Vasu on the first clinical evaluation of our off-the-shelf
universal donor K-NK-cell therapy in R/R AML as part of our K-NK003
cell therapy product program,” says Andrew Sandler, MD, chief
medical officer of Kiadis. “While this study will use our FC21
technology, we plan to leverage this study to initiate a company
sponsored study at OSU and other sites with our particle production
platform (PM21) in the same patient population later this year. Our
proprietary PM21 platform is the only technology that produces
NK-cell therapy without the use of feeder cell lines, which carry
the risk of tumor cells and DNA in the final product.”
The NK cell product will be manufactured in the
OSU Cell Therapy Lab under the direction of Lynn O’Donnell, PhD,
Director of Cell Therapy Engineering at OSUCCC - James Pelotonia
Institute for Immuno-Oncology.
O’Donnell notes this off-the-shelf NK cell
therapy is unique in several ways:
- It is derived from normal human donors who have undergone the
full FDA-mandated screening process and are demonstrating excellent
NK cell expansion using the Kiadis FC21 technology.
- The OSUCCC – James team is able to bank the cells ahead of
patient enrollment. “Because of this, we do not need to wait for
QC/QA release or ‘matching’ the donor to the recipient, saving
weeks of critical time for patients with aggressive disease, “ says
O’Donnell, who also serves as an associate professor at The Ohio
State University College of Medicine.
- The NK cells are not genetically engineered like CAR-T cells,
CAR-NK cells, or other allogeneic NK cell products, which O’Donnell
notes eliminates the need for long-term follow up of patients, and
reduces the overall regulatory burden.
- NK cells are not derived from induced pluripotent stem cells or
an irradiated tumor cell line, eliminating another source of risk
for the patients long-term.
Vasu and O’Donnell have no potential financial
conflicts of interest related to Kiadis or this study to
disclose.
About Kiadis
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 kiadis.com.
Kiadis Contacts:
Kiadis Pharma:
Maryann Cimino, 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 |
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