Kiadis Pharma announces its deci­sion to file for mar­ket­ing autho­riza­tion with the European Medicines Agency (EMA) for ATIR101™ in blood can­cers

~ Regulatory strat­e­gy update ~

Amsterdam, The Netherlands, June 2, 2016, – 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 announces a reg­u­la­to­ry strat­e­gy update that, based on pos­i­tive Phase II data, it has tak­en the deci­sion to sub­mit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead prod­uct ATIR101™ for use in blood can­cers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-ver­sus-Host-Disease (GVHD) in the con­text of a hematopoi­et­ic stem cell trans­plan­ta­tion using a hap­loiden­ti­cal donor. The Company will now start com­pil­ing an MAA doc­u­ment and antic­i­pates sub­mit­ting the appli­ca­tion to EMA in Q1, 2017.
An EMA rap­por­teur and co-rap­por­teur (who will joint­ly co-ordi­nate the eval­u­a­tion of Kiadis Pharma’s MAA sub­mis­sion) were appoint­ed in ear­ly 2015. In addi­tion, in April 2015 Kiadis Pharma received a cer­tifi­cate for its (man­u­fac­tur­ing) qual­i­ty and non-clin­i­cal data from EMA.
Positive clin­i­cal data from Kiadis Pharma’s sin­gle dose Phase II tri­al (NCT01794299/EudraCT 2012-004461-41) with ATIR101™ was announced on April 4, 2016 at the Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in Valencia, Spain. The data showed that ATIR101™ sig­nif­i­cant­ly reduced TRM and sig­nif­i­cant­ly improved Overall Survival in com­par­i­son to a his­tor­i­cal con­trol group of patients that under­went a sim­i­lar T-cell deplet­ed hap­loiden­ti­cal donor trans­plan­ta­tion but with­out the addi­tion of ATIR101™. In addi­tion, ATIR101™ did not elic­it grade III-IV GVHD in any patient.
Recently, meet­ings were held with the EMA rap­por­teur and co-rap­por­teur dur­ing which Kiadis Pharma pre­sent­ed safe­ty and man­u­fac­tur­ing data as well as clin­i­cal data from this Phase II tri­al, a tri­al that was designed on the basis of sci­en­tif­ic advice pre­vi­ous­ly giv­en by EMA.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are excit­ed about the progress we have made with ATIR101™ over the past year. The Company is again enter­ing into a new phase in its devel­op­ment as we are start­ing prepa­ra­tions for com­mer­cial­iza­tion. The sub­mis­sion of an MAA in Q1, 2017 was our ambi­tious upside-plan com­mu­ni­cat­ed at the time of our IPO, now a year ago, and we are mov­ing nice­ly ahead with good momen­tum. A launch of ATIR101™ in Europe could be pos­si­ble as ear­ly as 2018 if mar­ket­ing autho­riza­tion is grant­ed by EMA. We are also ful­ly com­mit­ted to start­ing the enroll­ment of patients into our planned ran­dom­ized, inter­na­tion­al con­trolled Phase III tri­al where we will com­pare the ATIR101™ approach with post-trans­plant cyclophos­phamide (Baltimore approach) in the con­text of hap­loiden­ti­cal trans­plan­ta­tion. I look for­ward to the future with tremen­dous excite­ment in this next phase.

Leave a Reply

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