Kiadis Pharma’s Pediatric Investigation Plan for ATIR101™ accept­ed by the European Medicines Agency’s Pediatric Committee

~ Paves the way for sub­mis­sion of a Marketing Authorization Application for ATIR101™ in Europe ~

Amsterdam, The Netherlands, March 28, 2017, – 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 that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has accept­ed the Company’s Pediatric Investigation Plan (PIP) for ATIR101™ for the adjunc­tive treat­ment in hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) for a malig­nant dis­ease. In addi­tion, the PDCO has agreed that the Company may defer con­duct­ing the stud­ies defined in the PIP until after it files a Marketing Authorization Application (MAA) in Europe for the use of ATIR101™ for the treat­ment of blood can­cers.

The Company’s PIP pro­vides for a Phase II tri­al to eval­u­ate the safe­ty and effi­ca­cy of ATIR101™ as an adjunc­tive treat­ment on top of an HSCT in pedi­atric patients up to 18 years of age with a hema­to­log­ic malig­nan­cy, who are eli­gi­ble for an HSCT but with­out the avail­abil­i­ty of a ful­ly matched donor. Patients will receive either an HSCT from a par­tial­ly matched (hap­loiden­ti­cal) relat­ed fam­i­ly donor with the adju­vant infu­sion of ATIR101™, or an HSCT using umbil­i­cal cord blood stem cells from an unre­lat­ed donor. The pri­ma­ry end­point of the tri­al will be Graftversus- Host-Disease-free, relapse-free sur­vival (GRFS).

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “The accep­tance of our pedi­atric devel­op­ment pro­gram by EMA’s PDCO is an impor­tant reg­u­la­to­ry mile­stone for ATIR101™. Furthermore, the PDCO’s deci­sion to allow us to defer the ini­ti­a­tion of our PIP means the Company can sub­mit an MAA to EMA for the use of ATIR101™ in adult blood can­cer patients sub­stan­tial­ly ear­li­er than if it was required to com­plete the PIP before­hand. This is an impor­tant step for­ward in our efforts to bring ATIR101™ to the mar­ket and evi­dences the close and con­struc­tive inter­ac­tions that Kiadis Pharma has estab­lished with the reg­u­la­to­ry author­i­ties in devel­op­ing ATIR101™“.

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