Amsterdam, The Netherlands, September
14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext
Amsterdam and Brussels: KDS), a clinical-stage
biopharmaceutical company developing innovative cell-based
medicines for the treatment of life-threatening diseases, today
announces a collaboration with the Abigail Wexner Research
Institute (AWRI) at Nationwide Children’s Hospital to develop
Kiadis-NK cells (K-NK cells) as a post-exposure pre-emptive therapy
for COVID-19. The U.S. Food and Drug Administration (FDA) approved
AWRI’s investigational new drug application (IND) for a study in an
adult population with off-the-shelf natural killer (NK) cells
produced with Kiadis’ proprietary Universal Donor and PM21
technologies. Kiadis and AWRI are developing the plan for
initiation of the clinical study.
Kiadis has exclusively licensed from AWRI
intellectual property related to NK cells for treatment of
microbial infections, including SARS-CoV-2. The Company has
recently initiated the preclinical and clinical development of its
K-NK-ID101 COVID-19 program and is expecting to receive US
government funding for this program.
Arthur Lahr, CEO of Kiadis commented, “This is
the second IND approved by the U.S. FDA for K-NK cells produced
with our PM21 platform, and the second IND approved for K-NK cells
based on our Universal Donor off-the-shelf platform. We are excited
to study whether K-NK cells have the anti-viral properties, safety
profile and manufacturing scalability to be widely deployed as an
off-the-shelf global countermeasure against COVID-19 and future
pandemic threats. This FDA approval marks rapid progress with our
K-NK-ID101 COVID-19 program and demonstrates the potential
expansion with our K-NK cells into infectious disease.”
“The coronavirus pandemic has had a significant
impact on our world, but has also created opportunities for
innovation and forward thinking,” says Dean Lee, MD, PhD, Director
of the Cellular Therapy and Cancer Immunotherapy program at
Nationwide Children’s Hospital. “Data from patients with COVID-19
have demonstrated an important role for NK cells in this disease.
Our previous collaborations with Kiadis in developing NK cells for
cancer enabled us to design a novel Phase I/II clinical trial that
meets FDA rigor in testing whether adoptive transfer of NK cells is
safe and effective in mitigating progression of this virus in
high-risk patients.”
Dutch Translation/Nederlandse
vertaling
Kiadis nv ('Kiadis') is een een
Nederlands beursgenoteerd biotechbedrijf dat nieuwe geneesmiddelen
ontwikkelt tegen ernstige ziekten. Het maakt daarbij gebruik van
Natural Killer-cellen (NK-cellen), grote witte bloedlichamen die de
eerste verdedigingslinie in het menselijk afweersysteem vormen
tegen kankercellen en infecties.
De Amerikaanse Food and Drug Administration
(FDA) keurde een aanvraag van Nationwide Children’s Hospital (NCH)
in Columbus, Ohio, goed voor een klinische studie in volwassenen
met Kiadis K-NK cellen geproduceerd met Kiadis’ Universal Donor- en
PM21 platform. Kiadis en NCH bereiden momenteel de start van de
studie voor.
Kiadis startte onlangs met de preklinische en
klinische ontwikkeling van haar K-NK-ID101 programma voor de
behandeling en preventie van COVID-19, en verwacht van de
Amerikaanse overheid subsidie te ontvangen.
Arthur Lahr, CEO van Kiadis
zegt: “Dit is de tweede door de FDA goedgekeurde klinische
studie met K-NK-cellen op basis van ons PM21-platform en ons
Universele Donorplatform. K-NK-cellen beschikken over de juiste
antivirale eigenschappen, veiligheidsprofiel en de
productieschaalbaarheid om breed te kunnen worden ingezet tegen
COVID-19 en toekomstige wereldwijde pandemieën. Deze
FDA-goedkeuring is tekenend voor de snelle voortgang met ons
K-NK-ID101 COVID-19-programma, en toont de potentie van onze
K-NK-cellen voor de behandeling van infectieziekten."
Dean Lee, MD PhD, Directeur van het
Cellular Therapy and Cancer Immunotherapy Program van het
Nationwide Children’s Hospital, zegt: “De corona-pandemie
heeft grote impact, maar biedt ook kansen op innovatie. Data van
patiënten met COVID-19 heeft aangetoond dat NK-cellen een
belangrijke rol spelen. De ontwikkeling van K-NK-cellen voor kanker
hielp bij het opzetten van deze nieuwe door de FDA goedgekeurde
fase I/II klinische studie naar de veiligheid en effectiviteit van
adoptieve overdracht van K-NK-cellen voor het inperken van het
corona virus bij hoog-risicopatiënten."
Dit persbericht vormt een vertaling van
het gepubliceerde Engelstalige persbericht. Bij eventuele
verschillen is de tekst van het Engelstalige persbericht altijd
bepalend.
About NK-cells and K-NK-cells in
COVID-19The scientific rationale for studying the infusion
of natural killer (NK) cells to control COVID-19 disease is
supported by literature. The vast majority of COVID-19 patients
have lymphocytopenia, or a shortage of lymphocytes – a type of
white blood cell that helps protect the body from infection. NK
cells are lymphocytes and COVID-19 disease severity is correlated
with a reduction in the number of NK cells, exhaustion of NK cells
and the lack of certain mature, potent NK-cell phenotypes. The
power of NK cells to fight various other viral infections, such as
CMV, BKV, HBV and HCV, has been well described, with a durable
change in the NK-cell profile towards those more mature and potent
phenotypes in recovered patients.
Kiadis research is aimed at studying the
properties of Kiadis K-NK cells and their suitability to fight
SARS-CoV-2 and to be developed as pre-exposure prophylaxis and
post-exposure pre-emptive therapy in high risk patients and
healthcare workers. K-NK cells enhance multiple aspects of
antiviral immunity. In immunocompromised transplant patients, K-NK
cells have shown significant reduction of potentially lethal CMV
reactivation and BKV infection. K-NK cells work synergistically
with antibodies, immunoglobulins and vaccines.
K-NK cells are being studied regarding their
anti-viral properties, safety profile and manufacturing scalability
to potentially be widely deployed as an off-the-shelf global
countermeasure against COVID-19 and future pandemic threats.
About Kiadis’ K-NK-cell Based
MedicinesKiadis’ NK-cell programs consist of off-the-shelf
and haplo donor cell-based medicines for the treatment of liquid
and solid tumors as adjunctive and stand-alone therapies.
Kiadis is also researching the use of its’ K-NK cell therapy
platform for the treatment of infectious diseases, with the first
potential application being the treatment of COVID-19.
The Company’s NK-cell PM21 particle technology
enables improved ex vivo expansion and activation of anti-cancer
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. The Kiadis off-the-shelf K-NK
platform can make NK-cell based product rapidly and economically
available for a broad patient population across a potentially wide
range of indications.
Kiadis is clinically developing K-NK003 for the
treatment of relapse/refractory acute myeloid leukemia. The Company
is also developing K-NK002, which is administered as an adjunctive
immunotherapeutic on top of HSCT and provides functional, mature
and potent NK-cells from a haploidentical family member.
Furthermore, Kiadis is developing K-NK-ID101 for the treatment of
Covid-19. In addition, the Company has pre-clinical programs
evaluating NK-cell based medicines for the treatment of solid
tumors and infectious diseases.
About KiadisFounded in 1997,
Kiadis is building a fully integrated biopharmaceutical company
committed to developing innovative cell-based medicines 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.
Disclosures: Dr. Lee was a
co-founder of CytoSen prior to its acquisition by Kiadis in 2019
and is currently chair of Kiadis’ scientific advisory board (SAB).
He holds stock in Kiadis, and has received financial compensation
from Kiadis for consulting, for serving on the Company’s SAB, and
for intellectual property licensed to Kiadis through Nationwide
Children’s Hospital. Dr. Lee will receive milestone payment
distributions related to the IP license.
Kiadis Contacts:
Kiadis:Maryann
Cimino, Senior Manager, Corporate AffairsTel: +1 (617)
710-7305m.cimino@kiadis.com |
LifeSpring Life Sciences
Communication:Leon Melens (Amsterdam)Tel: +31 538 16
427lmelens@lifespring.nl Optimum Strategic
Communications: Mary Clark, Supriya Mathur Tel: +44 203
950 9144 kiadis@optimumcomms.com |
Nationwide Children’s Hospital Media
Relations Contact:Mary Ellen Fiorino, Media Relations
ManagerTel:
614-937-7316maryellen.fiorino@nationwidechildrens.org
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect Kiadis’ or, as appropriate, Kiadis’
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
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
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.