First patient enrolled in Phase 3 tri­al for ATIR101™ in adult patients with blood can­cer

Amsterdam-Duivendrecht, The Netherlands, December 4, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell-ther­a­py prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that the first patient has been enrolled in the HATCY Phase 3 clin­i­cal tri­al for ATIR101™.
The multi­na­tion­al tri­al will eval­u­ate the safe­ty and effi­ca­cy of ATIR101™ as an adjunc­tive treat­ment to blood stem cell trans­plan­ta­tion from a half-matched (hap­loiden­ti­cal) fam­i­ly donor com­pared to post-trans­plant cyclophos­phamide (PTCy or ‘Baltimore’ pro­to­col) in adult patients with blood can­cer.
Andrew Sandler, Chief Medical Officer of Kiadis Pharma, com­ment­ed: “We are pleased that the first patient has been enrolled in the Phase 3 tri­al for our inno­v­a­tive cell-ther­a­py prod­uct ATIR101™. Although the ‘Baltimore’ pro­to­col has made hap­loiden­ti­cal trans­plants fea­si­ble, a huge unmet need remains due to high relapse rates and occur­rence of graft ver­sus host dis­ease.
Arthur Lahr, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “The start of this large multi­na­tion­al Phase 3 clin­i­cal tri­al marks anoth­er impor­tant step in the devel­op­ment of Kiadis. We aim to sub­mit the results from this Phase 3 tri­al to the US FDA, while we con­tin­ue to progress the European fil­ing sub­mit­ted ear­li­er this year to EMA based on our Phase 2 data.

About the HATCY Phase 3 tri­al
This Phase 3 tri­al (ClinicalTrial.gov iden­ti­fi­er: NCT02999854; EudraCT num­ber: 2016-004672-21; Kiadis num­ber: CR-AIR-009; Kiadis name: HATCY) will enroll 195 patients in Europe, US and Canada. The pri­ma­ry objec­tive of this ran­dom­ized, open label, par­al­lel arm Phase 3 tri­al is to com­pare safe­ty and effi­ca­cy of a hap­loiden­ti­cal (half-matched fam­i­ly donor) T-cell deplet­ed hematopoi­et­ic stem-cell trans­plant (HSCT) and adjunc­tive treat­ment with ATIR101™ ver­sus a hap­loiden­ti­cal T-cell replete HSCT with post-trans­plant admin­is­tra­tion of high dose cyclophos­phamide in adult patients with acute myeloid leukemia (AML), acute lym­phoblas­tic leukemia (ALL) or myelodys­plas­tic syn­drome (MDS). The pri­ma­ry com­pos­ite end­point is graft-ver­sus-host dis­ease free and relapse-free sur­vival (GRFS), sec­ondary end­points include over­all sur­vival (OS). An addi­tion­al objec­tive of the study is to com­pare the effect of the two treat­ments on qual­i­ty of life and health eco­nom­ics. The study is event dri­ven and the pri­ma­ry analy­sis will be per­formed after 93 GRFS event.