- Funding for COVID-19 research and
development program (K-NK-ID101), to investigate the potential to
establish it as a universal countermeasure to fight COVID-19 and
future pandemics
- Funding obtained from the Advanced Regenerative Manufacturing
Institute’s BioFabUSA program, in partnership with the United
States Department of Defense (DoD)
- Provides foundation for evaluating K-NK-ID101 as a protection
for immunocompromised and high-risk patients against multiple
seasonal respiratory infections, including influenza and RSV,
either alone or in combination with vaccines and antibodies
Amsterdam, The Netherlands, September
15, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext
Amsterdam and Brussels: KDS), a clinical stage
biopharmaceutical company developing innovative NK-cell-based
medicines for the treatment of life-threatening diseases, announces
that Kiadis has received $9.5 million in funding from the Advanced
Regenerative Manufacturing Institute’s (ARMI) BioFabUSA program, in
partnership with the United States Department of Defense (DoD), to
fund Kiadis’ K-NK-ID101 program. The funds from ARMI|BioFabUSA
provides funding for Kiadis’ research on K-NK-ID101’s activity and
mode of action in COVID-19 treatment, including the recently
announced Dutch research program. In addition, the funds will
support a new Company-sponsored Phase 1/2a clinical trial to
evaluate K-NK-ID101 in COVID-19 and the scale up of GMP
manufacturing.
Additionally, Kiadis will collaborate with
ARMI|BioFabUSA to establish large-scale manufacturing capacity for
K-NK-ID101 in the US that can support the industrialization of K-NK
cell therapy. ARMI|BioFabUSA received funding from the United
States Department of Defense (DoD) to advance large-scale
manufacturing of engineered tissues and tissue-related
technologies, including cell therapy.
Arthur Lahr, chief executive officer of
Kiadis, commented: “K-NK cells could potentially offer a
universal pandemic preparedness platform, for COVID-19 and future
pandemics. Over time, K-NK cells could be developed to protect
immunocompromised and high-risk patients against multiple seasonal
respiratory infections, including influenza and RSV, either alone
or in combination with vaccines and antibodies. We are excited to
collaborate with ARMI|BioFabUSA to perform required R&D and
support building out our K-NK manufacturing capacity, which will
benefit all our programs. If our K-NK-ID101 Phase 1/2a study is
successful, we anticipate pursuing further funds to support late
stage development and scale up production to millions of doses in
the US.”
Dean Kamen, Executive Director of ARMI
said: “Our partnership with Kiadis on development of K-NK
cells as a treatment for COVID-19 is precisely why ARMI|BioFabUSA
was created. We are now able to react quickly to a global pandemic
thanks to the biofabrication ecosystem created by our partner
organizations. The Department of Defense funding shows confidence
in our ability to produce results.”
ABOUT K-NK Cells and
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. K-NK cells can 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.
Kiadis believes that K-NK cells have the
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.
Dutch Translation/Nederlandse
vertaling
Kiadis Pharma nv ('Kiadis') (Euronext
Amsterdam en Brussel: KDS), is 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. Kiadis heeft een subsidie van $9,5
miljoen ontvangen van het Amerikaanse Ministerie van Defensie
(MvD), via het Advanced Regenerative Manufacturing Institute
(ARMI|BioFabUSA program). Hiermee is Kiadis’ K-NK-ID101-programma
thans volledig gefinancierd.
De subsidie van het Amerikaanse Ministerie van
Defensie financiert het onlangs bekendgemaakte Nederlandse
onderzoeksprogramma naar effectiviteit van K-NK-ID101 bij COVID-19,
een nieuwe fase 1/2a klinische trial met K-NK-ID101 in COVID-19, en
de opschaling van GMP-productie van K-NK-ID101.
Daarnaast zal Kiadis met ARMI|BioFabUSA
samenwerken voor het realiseren van grootschalige productie van
K-NK-ID101 in de VS.
ARMI|BioFabUSA wordt gefinancierd door het
Amerikaanse Ministerie van Defensie voor ontwikkeling en productie
van weefsel-gerelateerde technologieën, waaronder celtherapie.
Arthur Lahr, chief executive officer van
Kiadis, zegt in reactie: “K-NK-celtherapie bieden een
potentieel universeel platform voor pandemieën zoals COVID-19. De
brede anti-virale werking van K-NK-cellen biedt de mogelijkheid om
patiënten te beschermen tegen diverse luchtweginfecties zoals
influenza, corona en RSV. We zijn bijzonder verheugd dat het
Amerikaanse ministerie van Defensie ons via ARMI|BioFabUSA de
financiële middelen geeft voor dit programma en de uitbouw van onze
K-NK-productiecapaciteit. Bij een succesvol verloop verwachten we
meer fondsen te kunnen ontvangen voor verdere ontwikkeling van
K-NK-ID101 en opschaling van productie in de VS naar miljoenen
doses."
Dean Kamen, directeur van ARMI
zegt: “Onze samenwerking met Kiadis in de ontwikkeling van
K-NK-cellen voor de behandeling van COVID-19 toont waarom we
ARMI|BioFabUSA hebben opgericht. We kunnen nu snel reageren op de
wereldwijde pandemie dankzij de productietechnologie van onze
partners. De financiering van het Ministerie van Defensie bewijst
het vertrouwen in ons succes"
Over K-NK-cellen en COVID-19De
wetenschappelijke rationale voor het onderzoek naar de toediening
van natural killer (NK)-cellen tegen COVID-19, wordt ondersteund
door de literatuur. De overgrote meerderheid van de
COVID-19-patiënten heeft lymfocytopenie of een tekort aan
lymfocyten - een type witte bloedcel dat het lichaam helpt
beschermen tegen infecties. NK-cellen zijn lymfocyten en de ernst
van de ziekte van COVID-19 is gecorreleerd met een vermindering van
het aantal NK-cellen, uitputting van NK-cellen en het ontbreken van
bepaalde volwassen, krachtige NK-celfenotypes. De werking van
NK-cellen tegen andere virale infecties zoals CMV, BKV, HBV en HCV
is goed beschreven, met een duurzame verandering in het
NK-celprofiel naar de meer volwassen en potente fenotypes bij
herstelde patiënten.
De unieke eigenschappen van Kiadis’ K-NK-cellen
maken ze bij uitstek geschikt als therapie tegen SARS-CoV-2 en
uiteindelijk als preventieve therapie voor patiënten met een hoog
risico. K-NK-cellen versterken antivirale immuniteit. Bij
transplantatiepatiënten hebben K-NK-cellen een significante
vermindering van potentieel dodelijke CMV-reactivering en
BKV-infectie laten zien. K-NK-cellen werken synergetisch met
antilichamen, immunoglobulinen en vaccins.
K-NK-cellen hebben de antivirale eigenschappen,
het veiligheidsprofiel en de schaalbaarheid in productie om op
grote schaal te worden ingezet als een standaard wereldwijd middel
tegen COVID-19 en toekomstige pandemieën.
Dit persbericht vormt een samenvatting
van het gepubliceerde Engelstalige persbericht. Bij eventuele
verschillen is de tekst van het Engelstalige persbericht altijd
leidend.
About Kiadis’ K-NK-Cell
Therapies Kiadis’ K-NK-cell therapy programs in
immuno-oncology consist of off-the-shelf and haploidentical donor
cell therapy products 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 PM21 particle technology enables
improved ex vivo expansion and activation of anti-cancer cytotoxic
K-NK-cells supporting multiple high-dose infusions. Kiadis’
proprietary off-the-shelf K-NK-cell platform is based on NK-cells
from unique universal donors. The Kiadis off-the-shelf K-NK
platform can make NK-cell therapy 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. In
addition, the Company has pre-clinical programs evaluating NK-cell
therapy for the treatment of solid tumors.
About ARMIThe Advanced
Regenerative Manufacturing Institute (ARMI), headquartered in
Manchester, NH, is an organization funded by the United States
Department of Defense. ARMI's mission is to make practical the
large-scale manufacturing of engineered tissues and tissue-related
technologies, to benefit existing industries and grow new ones.
ARMI brings together a consortium of over 150 partners from across
industry, government, academia and the non-profit sector to develop
next-generation manufacturing processes and technologies for cells,
tissues and organs. For more information on ARMI, please visit
www.ARMIUSA.org.
About KiadisFounded in 1997,
Kiadis 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: Maryann
Cimino, Sr. Manager, Corporate Affairs Tel: +1 (617) 710-7305
m.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 |
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.