Kiadis announces first patient enrolled in clinical study conducted at The Ohio State University in R/R AML with off-the-shelf K-NK cells from universal donors as part of its K-NK003 program

Amsterdam, The Netherlands, June 25, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital (OSUCCC-James), today announced that the first patient has been enrolled and treated in a phase I, 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 at the Cell Therapy laboratory at the OSUCCC-James using Kiadis’ FC21 and proprietary universal donor platforms. The trial is being conducted at the OSUCCC-James and is expected to provide valuable data to support Kiadis’ K-NK003 development program.

The phase I study, NCT04220684, 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 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. The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product. Kiadis is supporting the Investigator-sponsored study through a collaborative research agreement with OSUCCC-James.

Sumithira Vasu, MBBS, the principal investigator of the clinical trial, hematologist and scientist, Medical Director of the Cell Therapy Lab at OSUCCC-James, and associate professor at the Ohio State College of Medicine says, “This off-the-shelf universal donor NK cell therapy is an exciting new experimental treatment option for patients with R/R AML and MDS that allows us to infuse large numbers of hyperfunctional NK cells immediately when needed. Treating our first patient with this therapy is an important step in this ongoing clinical research.”

Andrew Sandler, MD, chief medical officer of Kiadis commented, “This trial uses a novel off-the-shelf, readily available NK cell product to treat a very sick and difficult-to-treat group of patients. We are very enthusiastic with the initiation of this trial and to be one step closer to bringing K-NK-cell therapies to a broad patient population across a potentially wide range of cancers.”

Kiadis contacts

Kiadis: Maryann Cimino, Sr. Manager, Corporate Affairs Tel: +1 (617) 710-7305 m.cimino@kiadis.com

LifeSpring LifeSciences 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

Dutch Translation/Nederlandse vertaling

Kiadis Pharma N.V. (‘Kiadis’ of de ‘Onderneming’) (Euronext Amsterdam en Brussel: KDS), een biofarmaceutisch bedrijf gericht op onderzoek in de klinische fase, en de Comprehensive Cancer Center – Arthur G. James Cancer Hospital van de Ohio State University (‘OSUCCC-James’), kondigen aan dat de eerste patiënt is behandeld in een fase-I klinische studie voor behandeling van patiënten met recidiverende of refractaire acute myeloïde leukemie (R/R AML). De studie wordt uitgevoerd door de OSUCCC-James met NK-cellen geproduceerd in het Cell Therapy laboratorium aan de OSUCCC-James op basis van de Kiadis FC21- en universele-donorplatforms. De studie zal naar verwachting waardevolle gegevens leveren voor het K-NK003 product van Kiadis.

In de fase-I studie (NCT04220684) wordt het NK-celproduct geëvalueerd bij maximaal 56 patiënten van 18-80 jaar met primaire refractaire AML, recidiverende AML of myelodysplastische syndromen (MDS). Het doel van de studie is om veiligheid, inductie van remissie, optimale dosering en responspercentage met NK celtherapie vast te stellen bij deze patienten. Deelnemende patiënten krijgen zes doseringen NK-cellen van 1 x 107 cellen/kg tot 1 x 108 cellen/kg. Kiadis ondersteunt de studie door middel van een  onderzoeksovereenkomst met Ohio State University.

Dit persbericht vormt een vertaling van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd bepalend.

About Kiadis’ K-NK-cell Therapies Kiadis’ NK-cell programs consist of off-the-shelf and haplo donor cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies. 

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 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 Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Acute myelogenous leukemia (AML) is the most common type of acute leukemia in adults and has the lowest survival rate of all leukemias. AML relapse affects nearly half of all leukemia patients who achieved remission after initial treatment and can continue to occur several months to several years after treatment with the majority of relapses occurring within two to three years of the initial treatment. Patients with relapsed or refractory leukemia have limited treatment options and poor survival rates.

The goal of treatment for acute myeloid leukemia (AML) is to put the leukemia into complete remission and to keep it that way. Unlike conventional chemotherapy options, which primarily target dividing cells, immunotherapeutic therapies aim at directing an immune response against tumor cells. Natural Killer (NK) cells are effector lymphocytes of the innate immune system capable of exerting anti-AML activity. The K-NK cell platform is a cell-based immunotherapy to treat patients with advanced blood cancer.

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 offices 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.

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.