Kiadis Pharma Announces Full Enrolment of its Phase II Clinical Study with Lead Product, ATIR101™

The tar­get 23 patients have now been enrolled

Amsterdam, the Netherlands, July 30, 2015, 7.00 CEST – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Euronext Brussels: KDS), a recent­ly list­ed clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell immunother­a­py treat­ments for blood can­cers and inher­it­ed blood dis­or­ders, today announces full enrol­ment of patients into its ongo­ing Phase II clin­i­cal study with its lead prod­uct, ATIR101™.
ATIR101™ is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from par­tial­ly matched (hap­loiden­ti­cal) fam­i­ly donors for blood can­cer patients who do not have a match­ing stem cell donor avail­able. The ongo­ing Phase II study with ATIR101™ is an inter­na­tion­al mul­ti-cen­tre study in which a total of 23 leukaemia patients, includ­ing patients with acute myeloid leukaemia (AML), acute lym­phoblas­tic leukaemia (ALL) and myelodys­plas­tic syn­drome (MDS), will be enrolled and treat­ed with ATIR101™ as part of their trans­plant reg­i­men.

The pri­ma­ry end­point of the study is the rate of Transplant Related Mortality (TRM) at six months after all­o­gone­ic hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT). To date, 21 out of the 23 enrolled patients have received their HSCT, 19 of which have also been dosed with ATIR101™. The remain­ing patients are at var­i­ous stages of treat­ment, either being pre­pared for HSCT or being dosed with ATIR101™. The 23rd patient is expect­ed to under­go treat­ment with ATIR101™ in Q3 2015 and the study will remain open for enrol­ment until this final patient has been treat­ed. Read-out of the pri­ma­ry end­point results is expect­ed in Q1 2016.

Dr. Jeroen Rovers, Chief Medical Officer of Kiadis Pharma, said: “We are grate­ful to all inves­ti­ga­tors in Canada, Belgium, Germany and the UK for col­lab­o­rat­ing with us and assist­ing us with the enrol­ment of patients into this study. We will con­tin­ue to work with them in order to pro­vide the best care pos­si­ble for all patients involved in the study. We would also like to thank the patients, donors and their fam­i­lies for their par­tic­i­pa­tion.”

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “Full enrol­ment into the study is an impor­tant mile­stone for Kiadis Pharma and one which we set out to achieve as stat­ed at the time of our recent suc­cess­ful IPO. The study has been pro­gress­ing well since the pub­li­ca­tion of the pos­i­tive inter­im data at ASH in 2014 and we expect read-out on the pri­ma­ry end­point, Transplant Related Mortality at six months after HSCT, to be avail­able in the first quar­ter of 2016. Reaching this enrol­ment tar­get brings us one step clos­er to bring­ing our lead prod­uct, ATIR101™, to the mar­ket and to the thou­sands of blood can­cer patients who are in need of a trans­plant.”

Interim data from a pre-spec­i­fied inter­im analy­sis in this study were pre­sent­ed by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and Chair of the study, at the 2014 American Society of Hematology (ASH) Annual Meeting in San Francisco. These data con­firmed the safe­ty of ATIR101™ admin­is­tra­tion with no grade III-IV (life-threat­en­ing) acute Graft ver­sus Host Disease (GVHD) occur­ring, despite the fact that no pro­phy­lac­tic immune sup­pres­sants were used. Only a lim­it­ed num­ber of grade I-II GVHD events were report­ed, all of which were treat­ed suc­cess­ful­ly. Furthermore, no relaps­es were report­ed in any of the first ten patients, with four out of the ten patients in fol­low-up for more than one year at the time of the inter­im analy­sis. These data are in line with the data pre­vi­ous­ly report­ed from Kiadis Pharma’s Phase I/II study with 19 patients.

Leave a Reply

Your email address will not be published. Required fields are marked *