Last patient dosed with ATIR101™ in the Phase II ‘008’ clin­i­cal tri­al

– Results from the sin­gle dose 1-year fol­low up con­sis­tent with pri­or Phase II study
– Data sup­ports already sub­mit­ted mar­ket­ing autho­riza­tion appli­ca­tion

Amsterdam-Duivendrecht, The Netherlands, January 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell ther­a­py prod­ucts aim­ing to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that the last patient in the Phase II CR-AIR-008 (‘008’) tri­al has received a sin­gle dose of ATIR101™.
This explorato­ry Phase II tri­al (clinicaltrials.gov iden­ti­fi­er: NCT02500550) was designed to eval­u­ate the safe­ty and effi­ca­cy of two dos­es of ATIR101™ in patients with a hema­to­log­ic malig­nan­cy who received a hematopoi­et­ic stem cell trans­plan­ta­tion from a hap­loiden­ti­cal (half-matched) donor.
A total of 15 patients were recruit­ed into the tri­al. Six of these patients received two dos­es of ATIR101™ before the inde­pen­dent data mon­i­tor­ing com­mit­tee (IDMC) rec­om­mend­ed that the tri­al should con­tin­ue treat­ing patients with one dose of ATIR101™ (announced on December 21, 2016). The remain­ing nine patients on the tri­al have now been treat­ed with a sin­gle dose of ATIR101™. Of these nine patients, five patients are 1-year post treat­ment and results are con­sis­tent with the pre­vi­ous­ly con­duct­ed 23-patient CR-AIR-007 sin­gle dose Phase II tri­al.
Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “We are pleased to have com­plet­ed enroll­ment into this Phase II study and can now ful­ly focus on enroll­ment of the Phase III study. The sin­gle dose 1-year results from this study fur­ther increase and sup­port the data in the mar­ket­ing autho­riza­tion appli­ca­tion (MAA) we sub­mit­ted to the European Medicines Agency (EMA) in April 2017. The Company remains on track to poten­tial­ly obtain (con­di­tion­al) EMA approval for ATIR101™ in Q4 2018 which would allow for a European launch in H2 2019.