Kiadis announces new data validating and enhancing its PM21 K-NK-cell platform presented today at the ASGCT virtual annual me...
12 Maio 2020 - 7:15AM
Kiadis announces new data validating and enhancing its PM21
K-NK-cell platform presented today at the ASGCT virtual annual
meeting
- The first poster presentation (abstract #427) demonstrates
similarity between K-NK cells produced with FC21 and PM21
- The second poster presentation (abstract #765) shows
preclinical data with enhanced K-NK cell production and
functionality using PM21.Fc
Amsterdam, The Netherlands, May 12, 2020 – Kiadis Pharma
N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels:
KDS), a clinical stage biopharmaceutical company, today
announces that new data related to its K-NK cell therapy platform
is being presented today at the American Society of Gene & Cell
Therapy (ASGCT) Virtual Meeting. The first set of data (abstract
#427) demonstrates similarity between K-NK cells produced using
Kiadis’ feeder cell technology (FC21) and K-NK cells produced
using Kiadis’ membrane particle technology (PM21). The second set
of data (abstract #765) relate to an enhanced K-NK cell production
platform called PM21.Fc. The data in the second poster show that
K-NK cell production using feeder cells or particles with an added
Fc domain not only increases K-NK cell expansion, but also improves
cytotoxicity and antibody-dependent cell-mediated cytotoxicity
(ADCC) toward tumor targets thus providing further enhanced
combination therapy opportunities with antibodies.
Abstract #427: Bridging NK cell expansion methods
towards a feeder-cell free scalable GMP production of
hyperfunctional NK cells Kiadis’ FC21 platform uses
K562 feeder cells that express membrane bound IL-21 and 41BB
ligand. The PM21 platform consists of the membrane particles of
FC21, that retain the stimulatory properties of the feeder cells,
without the need to use intact tumor cells. Kiadis’ process allows
K-NK cells to be expanded with PM21 in an industrial GMP compliant
process to enable high dose, low cost, and scalable production
without the risk of residual tumor cells in the final product.
The data presented compare lab scale and industrial scale K-NK
cells generated with FC21 and PM21 on expansion yield,
cytotoxicity, cytokine production (IFNγ and TNFα) and expression of
key receptors. Each of these were found to be similar for K-NK
cells produced with PM21 at lab scale and industrial scale as
compared with K-NK cells produced at lab scale with FC21. K-NK
cells produced at industrial scale with PM21 showed further
improved expansion rates upon implementation of optimized process
conditions. NK-cells were tested with comparable
characterization assays.
The bridging data presented today supported the recent U.S. Food
and Drug Administration’s approval of Kiadis’ investigational new
drug application, enabling the Company to proceed directly into a
Phase 2 study (called the NK-REALM study) of K-NK002 as an
adjunctive therapy to the haploidentical HSCT standard of care with
the goal of reducing relapse rates. This Phase 2 study will
be the first human trial using drug produced with Kiadis’ PM21
technology.
Arthur Lahr, CEO of Kiadis, commented, “Our promising
proof-of-concept data in 45 patients has been generated with K-NK
cells produced with FC21. The data in abstract #427 presented today
at ASGCT demonstrate the similarity between K-NK cells produced
with FC21 and PM21 at lab scale and from manufacturing runs from
our industrial scale GMP production process and thus provide a
bridge from our historical clinical data. We look forward to
initiating the recently approved Phase 2 NK-REALM study and
treating the first patients with K-NK cells industrially produced
with PM21.”
Abstract #765: NK cell Expansion and Phenotype Shaping
using CD16-targeted feeder cellsIn addition to Abstract
#427, Kiadis is also presenting abstract #765 with preclinical data
on a further enhanced K-NK cell production platform called PM21.Fc.
in a poster at ASGCT. PM21.Fc further enhances production and
functionality of K-NK cells using feeder cells or particles with an
added Fc domain (PM21.Fc). The researchers evaluated the use of
PM21.Fc expanded K-NK cells in combination with the monoclonal
antibodies Cetuximab for lung cancer and Trastuzumab for ovarian
cancer.
K-NK cells expanded with PM21.Fc secreted significantly higher
amount of TNFα and had greater cytotoxicity and higher
antibody-dependent cell-mediated cytotoxicity (ADCC) than K-NK
cells expanded with PM21, both standalone and in combination with
Cetuximab. Researchers also found that K-NK cells expanded with
FC21.Fc proliferate better in animal models than NK cells expanded
without the added Fc domain, with or without Trastuzumab.
Additionally, the enhanced proliferation of K-NK cells was
accompanied by increased cytotoxicity upon tumor engagement.
Arthur Lahr continued, “The data in abstract #765 provide
promising further evolution of our K-NK platform and shows that use
of PM21.Fc not only enhances the K-NK cell expansion, but also
increases cytotoxicity and ADCC toward tumor targets, through
further upregulation of CD16 on K-NK cells. These results support
further enhanced potential of combining K-NK cells with monoclonal
antibodies as a cancer therapeutic.”
Both posters are available at www.kiadis.com.
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’ 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’ 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 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 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 activities across the United States, Kiadis is
reimagining medicine by leveraging the natural strengths of
humanity and our collective immune system to source the best cells
for life.
Kiadis 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.
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 |
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,
anticipated or implied by the forward-looking statements. These
risks, uncertainties and assumptions could adversely affect the
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.
Forward-looking statements contained in this press release
regarding past trends or activities should not be taken as a
representation that such trends or activities will continue in the
future. As a result, Kiadis Pharma expressly disclaims any
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
press release or the actual occurrence of the anticipated or
implied developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.