Kiadis Pharma issues clin­i­cal and reg­u­la­to­ry progress update on ATIR101™ and ATIR201™

~ Pivotal Phase III tri­al with ATIR101™ ini­ti­at­ed ~
~ MAA sub­mis­sion to EMA for ATIR101™ pro­gress­ing well ~

Amsterdam, The Netherlands, February 6, 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 pro­vides a progress update on the clin­i­cal and reg­u­la­to­ry sta­tus of ATIR101™, the Company’s lead prod­uct to address the key risks and lim­i­ta­tions of hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) in blood can­cer.

Initiation of piv­otal Phase III tri­al with ATIR101™
Following reg­u­la­to­ry approval from the nation­al author­i­ty in Canada (Health Canada), the Company is pleased to announce the ini­ti­a­tion of its ran­dom­ized, con­trolled, transat­lantic Phase III tri­al with ATIR101™ (CR-AIR-009). Approximately 195 patients with acute leukemia will be enrolled in total in the Phase III tri­al and ran­dom­ized 1:1 to receive a hap­loiden­ti­cal allo­gene­ic HSCT using either the Kiadis Pharma approach with a sin­gle dose of ATIR101™ or the post-trans­plant cyclophos­phamide approach (also known as the Baltimore Protocol).

The tri­al pro­to­col has also been sub­mit­ted for approval and is being eval­u­at­ed by the United States FDA (Food and Drug Administration) as well as sev­er­al European reg­u­la­to­ry author­i­ties. Following approval the tri­al will be rolled out to addi­tion­al study cen­ters in the United States and Europe.
CTI Clinical Trial and Consulting Services, Inc., an inter­na­tion­al clin­i­cal con­tract research orga­ni­za­tion, has been appoint­ed to work with Kiadis Pharma to sup­port the clin­i­cal part of the tri­al and PCT, LLC, A Caladrius Company, a lead­ing exter­nal man­u­fac­tur­ing part­ner to the cell ther­a­py indus­try, will man­u­fac­ture ATIR101™ for the United States and Canada. The German Red Cross Blood Donor Service, Baden-Wuerttemberg-Hessen, will remain the man­u­fac­tur­er in Europe. All 15 study cen­ters that par­tic­i­pat­ed in the Company’s Phase II tri­als with ATIR101™ (CR-AIR-007 and CR-AIR-008) have con­firmed their inten­tion to par­tic­i­pate in the Phase III tri­al (CR-AIR-009). Kiadis Pharma is active­ly and rapid­ly align­ing more sites with the aim of hav­ing more than 40 sites in North America and Europe par­tic­i­pat­ing in the Phase III tri­al.

Ongoing CR-AIR-008 tri­al con­tin­ues to con­firm safe­ty pro­file of ATIR101™
Infusing a sin­gle dose of ATIR101™ con­tin­ues to be safe in the ongo­ing Phase II tri­al with ATIR101™ (CR-AIR-008) which, as pre­vi­ous­ly announced, is con­tin­u­ing to treat patients with a sin­gle dose of ATIR101™ accord­ing to the clin­i­cal pro­to­col and the rec­om­men­da­tion of the Independent Data Monitoring Committee (IDMC). Five patients in this tri­al have now been treat­ed with a sin­gle dose of ATIR101™ of which three were infused more than 120 to 150 days ago. None of these patients have shown any symp­toms of severe Graft-ver­sus-Host-Disease (GVHD), with none hav­ing received any pro­phy­lac­tic immuno­sup­pres­sion.

MAA sub­mis­sion to EMA for ATIR101™ pro­gress­ing well
Following the Company’s deci­sion to sub­mit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of ATIR101™ in blood can­cers, Kiadis Pharma con­firms that the prepa­ra­tions for sub­mit­ting the dossier are pro­gress­ing well. The MAA will be based on the results from the Company’s suc­cess­ful sin­gle dose Phase II tri­al (CR-AIR-007) which con­firmed that ATIR101™ can be safe­ly infused and shows sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fits on over­all sur­vival and reduc­ing death from GVHD and infec­tions, com­pared to an obser­va­tion­al con­trol group of patients hav­ing received a sim­i­lar T-cell deplet­ed stem cell trans­plant from a hap­loiden­ti­cal fam­i­ly mem­ber but with­out the addi­tion of ATIR101™.
Kiadis Pharma has pre­vi­ous­ly received an Advanced Therapy Medicinal Product (ATMP) cer­tifi­cate from EMA for man­u­fac­tur­ing qual­i­ty and pre-clin­i­cal data, rec­og­niz­ing that this data gen­er­at­ed for ATIR101™ meets the strin­gent stan­dards imposed by the agency in eval­u­at­ing an MAA.

Contingent on approval from EMA, Kiadis Pharma antic­i­pates launch­ing ATIR101™ in to the European mar­ket in 2018.

Phase I/II tri­al with ATIR201™
As pre­vi­ous­ly announced, the Company’s Phase I/II clin­i­cal tri­al with its prod­uct ATIR201™ for tha­lassemia (CR-BD-001) has received reg­u­la­to­ry approval from the nation­al author­i­ty in the United Kingdom (the MHRA, the Medicines and Healthcare prod­ucts Regulatory Agency) as well as approval from the Ethics Committees of the Royal Manchester Children’s Hospital and the Birmingham Children’s Hospital. In addi­tion, approval from the Ethics Committee of the University of Regensburg in Germany has now been received, with reg­u­la­to­ry approval from the nation­al author­i­ty in Germany pend­ing. Kiadis Pharma expects the first clin­i­cal tri­al data to become avail­able in the sec­ond half of 2017.

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “I am very excit­ed that we have ini­ti­at­ed our piv­otal Phase III tri­al with ATIR101™. We have sig­nif­i­cant momen­tum now and the prepa­ra­tion of our MAA sub­mis­sion to EMA is pro­gress­ing well. This work will bring our poten­tial­ly life-sav­ing treat­ment, which is also pro­tect­ed by Orphan Drug Designations in both Europe and the US, one step clos­er to patients with an antic­i­pat­ed launch in Europe in 2018.

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