Kiadis Pharma files first inves­ti­ga­tion­al new drug appli­ca­tion with the U.S. FDA for nat­ur­al killer (NK) cell ther­a­py pro­duced with PM21

IND sup­ports the Company’s planned NK-REALM Phase 1/2 study which will eval­u­ate K-NK002 in 63 patients with blood can­cer under­go­ing a hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plant (HSCT)

Amsterdam, The Netherlands, April 9, 2020 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has filed an Investigational New Drug (IND) appli­ca­tion with the U.S. Food and Drug Administration (FDA) for the Company’s nat­ur­al killer cell ther­a­py prod­uct K-NK002. The IND cov­ers the pro­duc­tion of K-NK002 using Kiadis Pharma’s pro­pri­etary PM21 tech­nol­o­gy plat­form that enables high dose, low cost, scal­able and indus­tri­al pro­duc­tion of NK-cell ther­a­py with­out the risk of resid­ual tumor cells in the final prod­uct. The Company plans to ini­ti­ate a Phase 1/2 study with lead­ing trans­plant cen­ters in the U.S. to eval­u­ate K-NK002 once it receives FDA approval for the IND.  

Kiadis Pharma is devel­op­ing K-NK002 as an adjunc­tive ther­a­py to the cur­rent hap­loiden­ti­cal HSCT stan­dard of care with the goal of improv­ing relapse rates. The Phase 1/2 study, called NK-REALM (hap­loiden­ti­cal NK-cells to pre­vent post-trans­plant RElapse in AML and MDS), will eval­u­ate the use of K-NK002 as an adjunc­tive ther­a­py for blood can­cer patients under­go­ing a hap­loiden­ti­cal HSCT with the cur­rent stan­dard of care, post-trans­plant cyclophos­phamide (PTCy) pro­to­col. The study, which will be con­duct­ed with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), will enroll 63 patients at lead­ing trans­plant cen­ters in the U.S. The study is designed to con­firm ear­li­er proof-of-con­cept data in 24 patients, which showed that adjunc­tive treat­ment with K-NK002 has the poten­tial to sub­stan­tial­ly improve out­comes for patients in need of HSCT.

Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed, “The fil­ing of this IND is an impor­tant step for­ward for Kiadis in bring­ing K-NK cell ther­a­py to patients in need. Under nor­mal cir­cum­stances, the FDA would take 30 to 60 days to review an IND, but giv­en the cur­rent envi­ron­ment it is dif­fi­cult to project a date for IND approval. Once approved, we are ready to imme­di­ate­ly ini­ti­ate the tri­al with the BMT CTN, and ramp up pro­duc­tion of clin­i­cal mate­ri­als.”

About Kiadis Pharma’s K-NK-Cell Therapies 
Kiadis Pharma’s K-NK plat­form is designed to deliv­er potent NK cells to help each patient, with­out the need for genet­ic engi­neer­ing. Kiadis Pharma’s pro­grams con­sist of off-the-shelf and hap­loiden­ti­cal donor NK-cell ther­a­py prod­ucts for the treat­ment of liq­uid and sol­id tumors as adjunc­tive and stand-alone ther­a­pies. 

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

Kiadis Pharma is devel­op­ing K-NK002, which is admin­is­tered as an adjunc­tive immunother­a­peu­tic on top of HSCT, and K-NK003 for the treat­ment of relapse/refractory acute myeloid leukemia. In addi­tion, Kiadis Pharma has pre-clin­i­cal pro­grams eval­u­at­ing NK-cell ther­a­py for the treat­ment of sol­id tumors. 

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