Press Release

Kiadis receives $9.5 million from the Advanced Regenerative Manufacturing Institute’s BioFabUSA Program to fund Kiadis K-NK cell COVID-19 therapy

September 15, 2020 at 1:00 AM EDT
  • 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-19
The 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-19
De 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 ARMI
The 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 Kiadis
Founded 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 16 427
lmelens@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.

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