Kiadis Pharma pro­vides update on sec­ond dose tri­al (CR-AIR-008) with ATIR101™

~ Trial con­tin­ues accord­ing to pro­to­col with one dose ~

Amsterdam, The Netherlands, December 21, 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 an update on the sec­ond dose Phase II tri­al with ATIR101™ (CR-AIR-008). The Company will con­tin­ue its CR-AIR-008 tri­al, treat­ing patients with a sin­gle dose of ATIR101™ accord­ing to the rec­om­men­da­tion of the Independent Data Monitoring Committee (IDMC) and accord­ing to the clin­i­cal pro­to­col.

In this ongo­ing explorato­ry Phase II tri­al the safe­ty and effi­ca­cy of a sec­ond dose of ATIR101™ is being test­ed in patients to inves­ti­gate prod­uct flex­i­bil­i­ty in admin­is­ter­ing a fur­ther dose of ATIR101™ should it be need­ed by physi­cians. Fifteen patients have been recruit­ed into the tri­al to date of which ten have received one or two dos­es of ATIR101™ after their hap­loiden­ti­cal stem cell trans­plan­ta­tion (HSCT). All ten patients received a first dose of the same effi­ca­cious lev­el as the patients in the Company’s oth­er tri­als, and, as in the oth­er tri­als with a sin­gle dose of ATIR101™, no patient suf­fered from grade III/IV Graft-ver­sus-Host-Disease (GVHD) upon infu­sion of the first dose. Subsequently, six of the ten patients received a sec­ond dose of ATIR101™. Following this sec­ond infu­sion, some of the six patients sub­se­quent­ly suf­fered from var­i­ous grades of GVHD, includ­ing grade III/IV GVHD.

After con­sul­ta­tion with the IDMC, the IDMC rec­om­mend­ed to pro­ceed accord­ing to the pre­de­fined safe­ty mea­sure set out in the tri­al pro­to­col, which is to con­tin­ue with the tri­al, dos­ing patients with one dose of ATIR101™ at the effi­ca­cious lev­el but not to pro­vide a sec­ond dose of ATIR101™. Patient safe­ty is para­mount to the Company, hence it ful­ly sup­ports this rec­om­men­da­tion and will con­tin­ue to enroll and treat patients until 15 patients have received at least a sin­gle dose of ATIR101™.
In the mean­time, prepa­ra­tions for the Company’s Phase III tri­al with ATIR101™ (CR-AIR-009) are mov­ing rapid­ly ahead, the tri­al hav­ing been sub­mit­ted to reg­u­la­to­ry author­i­ties where it is cur­rent­ly under review for approval.

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “Physicians who are famil­iar with ATIR101™ were inter­est­ed to see us explore the poten­tial flex­i­bil­i­ty of ATIR101™ in a small sec­ond dose pro­to­col tri­al and this was the rea­son for this spe­cif­ic pro­to­col design. As also recon­firmed by the first results of this sec­ond dose tri­al, ATIR101™ remains safe as a sin­gle dose reg­i­men and the treat­ment of patients with ATIR101™ has shown very impres­sive safe­ty and effi­ca­cy results as pre­sent­ed at ASH only two weeks ago. As pre­vi­ous­ly com­mu­ni­cat­ed in August this year, our ran­dom­ized, con­trolled, inter­na­tion­al Phase III tri­al will be con­duct­ed with a sin­gle dose of ATIR101™ to most close­ly mim­ic the set up, dose lev­els and dos­ing schemes as pre­vi­ous­ly used in the Company’s CR-AIR-007 Phase II sin­gle dose tri­al, and to min­i­mize Phase III study risks by not chang­ing design vis-à-vis a Phase II tri­al. Conceptually, we still believe that a sec­ond dose of ATIR101™ might add ben­e­fit with even fur­ther improved relapse pro­phy­lax­is and infec­tion con­trol beyond the already demon­strat­ed sig­nif­i­cant ben­e­fit of a sin­gle dose. Therefore, once the CR-AIR-008 tri­al is com­plete and all data have been ful­ly eval­u­at­ed, we will assess the dose lev­el and tim­ing of a sec­ond dose of ATIR101™ for pos­si­ble future devel­op­ment.

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