Kiadis Pharma pro­vides reg­u­la­to­ry update on ATIR101

  • Kiadis no longer expects EU con­di­tion­al mar­ket­ing autho­riza­tion for ATIR101 in 2020
  • Kiadis plans to refile at the con­clu­sion of the ongo­ing phase 3 tri­al 

Amsterdam, The Netherlands, 17 October 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it no longer expects to receive EU con­di­tion­al mar­ket­ing autho­riza­tion for ATIR101 in 2020. The Company expects that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) will issue a neg­a­tive opin­ion and rec­om­mend against con­di­tion­al mar­ket­ing autho­riza­tion at the next CHMP meet­ing in November 2019.  

Arthur Lahr, CEO of Kiadis Pharma com­ment­ed, “Today’s news is very dis­ap­point­ing, espe­cial­ly for patients who could ben­e­fit from treat­ment with ATIR101. We filed a mar­ket­ing autho­riza­tion appli­ca­tion (MAA) in 2017 with our phase 2 ATIR101 data and his­tor­i­cal T-cell deplete hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plant (HSCT) con­trol data based on input from EMA that these were con­sid­ered ade­quate for review. Feedback from the EMA now indi­cates that the phase 2 data and his­tor­i­cal T-cell deplete con­trol data do not pro­vide ade­quate sup­port for a mar­ket­ing autho­riza­tion due to the evo­lu­tion of the stan­dard of care with the post-trans­plant cyclophos­phamide (PTCy, aka Baltimore) pro­to­col.” 

Kiadis is cur­rent­ly enrolling a glob­al, 250 patient, ran­dom­ized phase 3 tri­al, com­par­ing patients treat­ed with ATIR101 after a T-cell deplete HSCT to patients treat­ed with a T-cell replete hap­loiden­ti­cal HSCT based on the PTCy pro­to­col. Completion of enrol­ment and inter­im read­out of the phase 3 study are expect­ed in 2021. If pos­i­tive, the study will be the basis for fil­ing of a bio­log­ics license appli­ca­tion (BLA) with the US Food and Drug Administration (FDA) and a new MAA with the EMA. 

Mr. Lahr con­tin­ued, “The ran­dom­ized phase 3 tri­al, if pos­i­tive, should address EMA’s con­cerns, as it com­pares ATIR101 to the cur­rent stan­dard of care, the PTCy pro­to­col. HSCT patients are in need of new treat­ment options and we will work dili­gent­ly to advance our HSCT pro­grams, while also pur­su­ing can­cer ther­a­peu­tics with our NK-cell plat­form.”  

Scott Holmes, CFO of Kiadis Pharma added, “We do not believe that this set­back sig­nif­i­cant­ly changes the long-term rev­enue poten­tial for ATIR or the near-term cash needs of Kiadis. Revenue expec­ta­tions in the ini­tial years of European launch were min­i­mal and would not have pro­vid­ed a pos­i­tive oper­at­ing mar­gin. Importantly, we planned for and are enrolling the phase 3 study nec­es­sary for poten­tial reg­u­la­to­ry approval in the United States, and now the European Union.”   

About ATIR101 and KNK002 
Kiadis has two cell-based ther­a­peu­tics in devel­op­ment for patients with late-stage blood can­cer under­go­ing a hematopoi­et­ic stem cell trans­plant: T-cell based ATIR101 and NK-cell based KNK002. Administered as adjunc­tive immunother­a­peu­tics on top of HSCT, ATIR101 and KNK002 pro­vide lym­pho­cyte infu­sions with func­tion­al, mature and potent immune cells from a hap­loiden­ti­cal fam­i­ly mem­ber. The T-cells in ATIR101 and NK-cells in KNK002 will help fight infec­tions and remain­ing tumor cells until the immune sys­tem has ful­ly re-grown from stem cells in the trans­plant­ed graft. 

In ATIR101, T-cells that would cause GVHD are deplet­ed from the donor lym­pho­cytes, using our pho­tode­ple­tion tech­nol­o­gy. At the same time, ATIR101 con­tains poten­tial can­cer-killing T-cells from the donor that could elim­i­nate resid­ual can­cer cells and help pre­vent relapse of the dis­ease. Our NK-cell nanopar­ti­cle pro­cess­ing tech­nol­o­gy enables improved ex vivo expan­sion and acti­va­tion of NK-cells sup­port­ing mul­ti­ple high-dose infu­sions with potent anti-can­cer cyto­tox­i­c­i­ty. 

In addi­tion, Kiadis is devel­op­ing NK-cell based ther­a­pies for the treat­ment of relapse/refractory AML and has pre-clin­i­cal pro­grams eval­u­at­ing NK-cell ther­a­py for the treat­ment of sol­id tumors.

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