Kiadis Pharma changes strat­e­gy to focus sole­ly on devel­op­ment of Natural Killer (NK) Cell ther­a­peu­tics and ter­mi­nates devel­op­ment of ATIR101

  • Kiadis will focus all future invest­ments on devel­op­ing off-the-shelf and hap­lo donor NK-cell ther­a­pies for the treat­ment of sol­id and liq­uid tumors
  • Discontinues devel­op­ment of ATIR101, stop­ping phase 3 tri­al 
  • Restructures orga­ni­za­tion; reduc­ing work­force by approx­i­mate­ly half 

Amsterdam, The Netherlands, 12 November 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has com­plet­ed a strate­gic port­fo­lio review and has decid­ed to change its strat­e­gy and focus all resources and invest­ments on the company’s NK-cell ther­a­py plat­form and prod­uct can­di­dates. The com­pa­ny will dis­con­tin­ue devel­op­ment of ATIR101 and stop its ongo­ing phase 3 tri­al.   

Kiadis’ NK-cell pro­gram con­sists of off-the-shelf and hap­lo donor cell ther­a­py prod­ucts for the treat­ment of liq­uid and sol­id tumors. Kiadis’ pro­pri­etary off-the-shelf NK-cell plat­form is based on NK-cells from unique uni­ver­sal donors, expand­ed and acti­vat­ed ex vivo using our PM21 par­ti­cle tech­nol­o­gy. The Kiadis off-the-shelf plat­form has the poten­tial to make NK-cell ther­a­py prod­ucts rapid­ly and eco­nom­i­cal­ly avail­able for a broad patient pop­u­la­tion across a poten­tial­ly wide range of indi­ca­tions.

The company’s pipeline includes:

  • K-NK002: A phase 1/2 study will begin in 2020 eval­u­at­ing K-NK002 as an adjunc­tive treat­ment to the cur­rent stan­dard-of-care hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) with post-trans­plant cyclophos­phamide (PTCy). Relapse remains an issue with the PTCy pro­to­col. The phase 1/2 study was designed based on promis­ing clin­i­cal proof-of-con­cept data in 25 patients that demon­strat­ed a reduc­tion of long-term relapse rates from 45% in a matched con­tem­po­ra­ne­ous con­trol of patients treat­ed with PTCy, to 8% of patients treat­ed with PTCy and K-NK002 (Blood 2017, ASCO 2018). The 63 patient phase 1/2 study will be con­duct­ed in col­lab­o­ra­tion with the Bone Marrow Transplant Clinical Trial Network (BMT-CTN), which con­sists of the pre­mier trans­plant clin­ics in the United States.
  • K-NK003: A phase 1/2A study will begin in 2020 eval­u­at­ing K-NK003 as a treat­ment for patients with relapse and refrac­to­ry acute myeloid leukemia. The tri­al is designed based on clin­i­cal proof-of-con­cept data that showed a 69% com­plete response rate (Haplo 2018).
  • Pre-clin­i­cal pro­grams: Kiadis has mul­ti­ple pre­clin­i­cal pro­grams eval­u­at­ing its K-NK-cell ther­a­pies for the treat­ment of sol­id tumors.

Arthur Lahr, CEO of Kiadis Pharma com­ment­ed, “We believe that our pro­pri­etary NK-cell ther­a­py plat­form has broad poten­tial as stand-alone or adjunc­tive treat­ments for patients with both liq­uid and sol­id tumors. Our off-the-shelf NK-cell plat­form is based on NK-cells from unique uni­ver­sal donors, expand­ed and acti­vat­ed with our PM21 par­ti­cle tech­nol­o­gy, to make our NK-cell ther­a­py prod­ucts rapid­ly and eco­nom­i­cal­ly avail­able for patients across a poten­tial­ly broad range of indi­ca­tions. The proof-of-con­cept tri­als for our NK pipeline pro­grams, in which 38 patients have been treat­ed, is very promis­ing and was the basis for our acqui­si­tion of Cytosen Therapeutics, Inc. ear­li­er this year. To con­firm find­ings from these tri­als, we will start two Phase 1/2 clin­i­cal tri­als in 2020. We believe that invest­ing in our NK plat­form and rapid­ly advanc­ing devel­op­ment of our off-the-shelf and hap­lo donor derived NK-cell ther­a­pies in sol­id and liq­uid tumors will bring val­ue to patients and our investors.” 

Lahr con­tin­ued, “As part of our strate­gic port­fo­lio review, we reviewed progress of our phase 3 study, which was designed to show supe­ri­or­i­ty of ATIR101 over the PTCy pro­to­col. We iden­ti­fied that in the phase 3 a high­er per­cent­age of patients than expect­ed dropped out of the study before receiv­ing ATIR101. We sub­se­quent­ly col­lect­ed addi­tion­al recent exter­nal data, which show that out­comes with PTCy have bet­ter sur­vival and low­er severe GVHD than lit­er­a­ture showed when we designed and start­ed the phase 3 study. Based on these data, we no longer believe that the phase 3 ATIR study as cur­rent­ly designed with 250 patients can demon­strate supe­ri­or­i­ty over PTCy and at a min­i­mum would require a much larg­er tri­al. In the best inter­est of patients, we have there­fore tak­en the deci­sion to dis­con­tin­ue the ATIR101 study with imme­di­ate effect and are pro­ceed­ing with close down activ­i­ties.”

Restructuring
Kiadis is imple­ment­ing a restruc­tur­ing pro­gram to refo­cus the orga­ni­za­tion on its NK-cell ther­a­py plat­form, which will result in a reduc­tion of approx­i­mate­ly half of its work­force, a reduc­tion in exter­nal clin­i­cal tri­al costs asso­ci­at­ed with the phase 3 study, and a reduced com­pa­ny cash burn. The com­pa­ny end­ed the third quar­ter of 2019 with approx­i­mate­ly €47 mil­lion of cash.

About Kiadis’ K-NK-Cell Therapies 
Kiadis’ NK-cell pro­grams con­sist of off-the-shelf and hap­lo donor cell ther­a­py prod­ucts for the treat­ment of liq­uid and sol­id tumors as adjunc­tive and stand-alone ther­a­pies.  

Our NK-cell PM21 par­ti­cle tech­nol­o­gy enables improved ex vivo expan­sion and acti­va­tion of anti-can­cer cyto­tox­ic NK-cells sup­port­ing mul­ti­ple high-dose infu­sions. Kiadis’ pro­pri­etary off-the-shelf NK-cell plat­form is based on NK-cells from unique uni­ver­sal donors. The Kiadis off-the-shelf K-NK plat­form can make NK-cell ther­a­py prod­uct rapid­ly and eco­nom­i­cal­ly avail­able for a broad patient pop­u­la­tion across a poten­tial­ly wide range of indi­ca­tions.

Administered as an adjunc­tive immunother­a­peu­tic on top of HSCT, K-NK002 pro­vides func­tion­al, mature and potent NK-cells from a hap­loiden­ti­cal fam­i­ly mem­ber.  In addi­tion, Kiadis is devel­op­ing K-NK003 for the treat­ment of relapse/refractory acute myeloid leukemia and has pre-clin­i­cal pro­grams eval­u­at­ing NK-cell ther­a­py for the treat­ment of sol­id tumors.

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