Kiadis Pharma presents an update on its Phase II tri­al with ATIR101™ at the American Society of Hematology 2015 Annual Meeting

– Statistically sig­nif­i­cant increase in Overall Survival and reduc­tion in Transplant Related Mortality observed in com­par­i­son to a his­tor­i­cal con­trol group
– Zero patients devel­oped grade III-IV acute Graft-ver­sus-Host-Disease upon infu­sion of ATIR101™
– Analysis of full read out of pri­ma­ry end­point data antic­i­pat­ed to be report­ed in April 2016

Amsterdam, The Netherlands, December 7, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell immunother­a­py treat­ments for blood can­cers and inher­it­ed blood dis­or­ders, today presents data from its ongo­ing Phase II clin­i­cal tri­al in leukaemia patients at the American Society of Hematology (ASH) 57th Annual Meeting in Orlando, Florida.
The Company presents an update on its ful­ly enrolled ongo­ing open label Phase II clin­i­cal tri­al (NCT01794299/EudraCT 2012-004461-41) with its lead prod­uct ATIR101™ added as a donor lym­pho­cyte infu­sion to a hap­loiden­ti­cal T-cell deplet­ed stem cell trans­plan­ta­tion.
Data pre­sent­ed in Session 732 (Clinical Allogeneic Transplantation) have a cut off date of November 23, 2015. As per that date a sta­tis­ti­cal­ly sig­nif­i­cant reduc­tion in Transplant Related Mortality (TRM) and a sta­tis­ti­cal­ly sig­nif­i­cant increase in Overall Survival (OS) is observed in com­par­i­son to a his­tor­i­cal con­trol group based on Kaplan-Meier esti­mates (p=0.002 and p=0.0006 respec­tive­ly).

Study details
Twenty-three leukaemia patients with a medi­an age of 41 years (range 21 – 64) have been enrolled into this tri­al from sites in Canada, Belgium, Germany and the UK. Patients were eli­gi­ble for an allo­gene­ic hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) but could not find a match­ing donor in time. Seventeen patients had acute myeloid leukaemia (AML) and 6 had acute lym­phoblas­tic leukaemia (ALL). All patients were either in first or sec­ond com­plete remis­sion at the time of HSCT. Myeloablative con­di­tion­ing reg­i­mens were used and (hap­loiden­ti­cal) donor grafts were deplet­ed of T-cells (CD34+ selec­tion) pri­or to trans­plan­ta­tion. All patients engraft­ed rapid­ly (medi­an 12 days) and sub­se­quent­ly ATIR101™ was infused at a fixed dose of 2×106 CD3+ cells/kg at a medi­an of 28 days post-trans­plant.
On November 23, 2015 the medi­an fol­low-up was 292 days post-HSCT. A total of 19 of the 23 patients were beyond 6 months post-HSCT, of which 15 were still alive at that time, and 15 patients were already 12 months post-HSCT, of which 10 were still alive.
No patients (0/23) devel­oped grade III-IV acute Graft-ver­sus-Host-Disease (GVHD) upon infu­sion of ATIR101™, con­firm­ing the effi­ca­cy of the elim­i­na­tion of allo-reac­tive T-cells from ATIR101™. Two cas­es of grade II acute GVHD were report­ed with a delayed onset, at day 173 and day 247 post-HSCT (145 and 219 days post ATIR101™ infu­sion) respec­tive­ly.
The pri­ma­ry end­point of the tri­al is TRM with­in 6 months post-HSCT. To date 3 cas­es of TRM have been report­ed with­in the first 6 months post-HSCT. In all cas­es the cause of death was an infec­tion.
When com­pared to a his­toric con­trol group (N=35) con­sist­ing of patients who under­went a sim­i­lar HSCT pro­ce­dure but with­out the addi­tion of ATIR101™, TRM was sig­nif­i­cant­ly low­er (p=0.002) in patients giv­en ATIR101™ after a T-cell deplet­ed hap­loiden­ti­cal trans­plan­ta­tion. Based on Kaplan-Meier esti­mates, the 6-month TRM for HSCT + ATIR101™ is 15% ver­sus 37% for HSCT only.
Disease relapse in the tri­al is lim­it­ed, with only one patient dying as a result of dis­ease relapse. Combined with the reduced rate of TRM this trans­lates into a sig­nif­i­cant­ly improved Overall Survival (p=0.0006) of patients under­go­ing HSCT + ATIR101™ com­pared to patients only under­go­ing HSCT. Based on the Kaplan-Meier esti­mates, the 1-year sur­vival in the HSCT + ATIR101™ group is 75% com­pared to only 20% in the his­toric con­trol group.
Full read out of the data for the pri­ma­ry end­point will be done at the end of Q1, 2016, when the last patient has reached the 6-month fol­low up. It is antic­i­pat­ed that the analy­sis of such data will be report­ed in April 2016.

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are very excit­ed and enthu­si­as­tic about the data from our Phase II tri­al to date. Compared to pre­vi­ous approach­es using T-cell deplet­ed hap­loiden­ti­cal HSCT, we have a real­ly strong effect with improved Overall Survival and low Transplant Related Mortality. Infusion of ATIR101™ did not cause life threat­en­ing grade III-IV GVHD show­ing the effi­ca­cy of elim­i­nat­ing allo-reac­tive T-cells. We are now look­ing for­ward to ini­ti­at­ing our planned Phase III inter­na­tion­al con­trolled tri­al com­par­ing the cur­rent Baltimore pro­to­col to our ATIR™ approach. We believe that the very low relapse rates and the absence of grade III-IV GVHD seen in our approach, in which no pro­phy­lac­tic immune-sup­pres­sion is used, will posi­tion ATIR™ very pos­i­tive­ly for patients.”

strong>Dr. Jeroen Rovers, Chief Medical Officer of Kiadis Pharma, added: “The data emerg­ing from this Phase II clin­i­cal tri­al pro­vides a very strong sig­nal on the effi­ca­cy of ATIR101™ and its capa­bil­i­ty to reduce life threat­en­ing infec­tions, improv­ing over­all sur­vival in patients who would oth­er­wise not have a cura­tive treat­ment option avail­able. It pro­vides a sol­id basis for dis­cus­sions with reg­u­la­to­ry author­i­ties on poten­tial ear­ly mar­ket approval.”

Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and prin­ci­pal inves­ti­ga­tor for the study, said: “The data we have seen to date from the var­i­ous cen­tres involved are high­ly con­sis­tent and ful­ly in line with what we have seen pre­vi­ous­ly in the Phase I tri­al of ATIR101™ that was done in patients with very poor prog­no­sis. The risk of grade III-IV GVHD seems to be com­plete­ly mit­i­gat­ed and no immune-sup­pres­sion is need­ed with low relapse rates and very good event free sur­vival. These results are sim­i­lar to those of patients receiv­ing trans­plants from matched donors.”

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