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KIADIS SUBMITS RESPONSE TO THE EUROPEAN MEDICINES AGENCY’S DAY 180 SECOND LIST OF OUTSTANDING ISSUES

22.MAY 2019 AT 20:11:16 CET

Amsterdam, The Netherlands, May 22, 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 sub­mit­ted a response to the European Medicines Agency’s (EMA) sec­ond Day 180 list of out­stand­ing issues for ATIR101. Kiadis sub­mit­ted a mar­ket­ing autho­riza­tion appli­ca­tion (MAA) to the EMA in 2017 seek­ing approval of ATIR101 as an adjunc­tive immunother­a­py for hematopoi­et­ic stem cell trans­plant (HSCT) in adults with late-stage blood can­cer. 
     
The sec­ond Day 180 List of Issues was focused on one remain­ing major obser­va­tion. In draft­ing the company’s response, Kiadis has thor­ough­ly ana­lyzed this obser­va­tion and have cre­at­ed mul­ti­ple analy­ses of exist­ing clin­i­cal data to address this obser­va­tion, includ­ing analy­ses of var­i­ous (pooled) ATIR and his­tor­i­cal con­trol data.

“We received the EMA’s day 180 sec­ond list of out­stand­ing issues in the fourth quar­ter of 2018, and have spent the past few months con­duct­ing addi­tion­al analy­sis of exist­ing data to sup­port our response,” said Arthur Lahr, CEO, of Kiadis Pharma. “With this sub­mis­sion com­plete, we aim to receive an opin­ion from Committee for Medicinal Products for Human Use (CHMP) in 2019. If the CHMP opin­ion is pos­i­tive, it would enable us to receive a con­di­tion­al mar­ket­ing approval from the European Commission, fol­lowed by com­mer­cial use of ATIR101 in a first patient in a European coun­try at the end of 2019.”

BE THE MATCH BIOTHERAPIES® AND KIADIS PHARMA ANNOUNCE STRATEGIC COLLABORATION TO ACCELERATE PATIENT ACCESS TO HAPLOIDENTICAL STEM CELL THERAPIES

22.MAY 2019 AT 18:00:00 CET

Collaboration will sup­port Phase III clin­i­cal tri­al of cell ther­a­py prod­uct ATIR101(TM) for blood can­cers
 
MINNEAPOLIS & AMSTERDAM, May 22, 2019 – Be The Match BioTherapies®, an orga­ni­za­tion offer­ing solu­tions for com­pa­nies devel­op­ing and com­mer­cial­iz­ing cell and gene ther­a­pies, and Kiadis Pharma N.V. (“Kiadis”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced a strate­gic col­lab­o­ra­tion to sup­port clin­i­cal eval­u­a­tion of an inno­v­a­tive cell ther­a­py prod­uct with poten­tial to make hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plan­ta­tions (HSCT) safer and more effec­tive for patients. 
 
Under the terms of the col­lab­o­ra­tion agree­ment, Be The Match BioTherapies will pro­vide logis­ti­cal and tech­no­log­i­cal solu­tions to sup­port Kiadis’ Phase III clin­i­cal tri­al for ATIR101, an adjunc­tive immunother­a­peu­tic designed to address key risks and lim­i­ta­tions of HSCT in the treat­ment of blood can­cers. 
 
Kiadis’ multi­na­tion­al Phase III clin­i­cal tri­al is eval­u­at­ing the safe­ty and effi­ca­cy of ATIR101 as an adjunc­tive treat­ment to HSCT from a half-matched (hap­loiden­ti­cal) fam­i­ly donor com­pared to post-trans­plant cyclophos­phamide (PTCy or “Baltimore” pro­to­col) in adult patients with blood can­cers. The Phase III study is cur­rent­ly enrolling patients in the EU, Canada, Israel and the U.S.
 
The col­lab­o­ra­tion will lever­age Be The Match BioTherapies’ indus­try-lead­ing exper­tise in cell deliv­ery logis­tics and sup­ply chain case man­age­ment, includ­ing the company’s MatchSource® end-to-end sup­ply chain man­age­ment soft­ware, to man­age the trans­port and pro­cess­ing of cel­lu­lar prod­ucts for use at Kiadis’ clin­i­cal tri­al sites in the U.S. and Canada.
 
“Kiadis’ quest to pro­vide bet­ter treat­ment out­comes for patients receiv­ing stem cell trans­plants is one we deeply share, giv­en the foun­da­tion­al role that our par­ent com­pa­ny, the National Marrow Donor Program®/Be The Match®, has played in improv­ing stem cell trans­plan­ta­tion for more than three decades,” said Chris McClain, vice pres­i­dent of Sales and New Business Development, Be The Match BioTherapies. “We look for­ward to uti­liz­ing our cell ther­a­py exper­tise to advance Kiadis’ impor­tant work.”
 
“We’re pleased to part­ner with Be The Match BioTherapies to progress our clin­i­cal inves­ti­ga­tion of ATIR101 and to expe­dite its avail­abil­i­ty to patients,” said Andrew Sandler, chief med­ical offi­cer of Kiadis Pharma. “We believe this ther­a­peu­tic approach could allow fam­i­ly mem­bers to serve as stem cell donors for those patients who would oth­er­wise not find a match­ing donor in time, ulti­mate­ly sav­ing lives.” 
 

KIADIS TO ACQUIRE CYTOSEN THERAPEUTICS, INC.

17.APRIL 2019 AT 07:00:00 CET


Kiadis to Acquire CytoSen Therapeutics, Inc.

  • Transaction cre­ates leader in cell-based can­cer immunother­a­py, with com­ple­men­tary T-cell and NK-cell plat­forms focused ini­tial­ly on hematopoi­et­ic stem cell trans­plants (HSCT)
  • CytoSen’s lead NK-cell ther­a­py can­di­date, CSDT002-NK, is expect­ed to enter clin­i­cal devel­op­ment in 2020 build­ing on suc­cess­ful clin­i­cal proof-of-con­cept stud­ies in 25 patients at the MD Anderson Cancer Center (MDACC)
  • The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to sup­port clin­i­cal devel­op­ment in lead­ing US trans­plant cen­ters
  • Dr. Carl Junea pio­neer in the devel­op­ment of CAR T-cell ther­a­py, to join Kiadis’ Scientific Advisory Board
  • Conference call for ana­lysts and investors today at 3:00pm CEST (9:00am EDT)

Amsterdam, The Netherlands, April 17, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has entered a defin­i­tive agree­ment to acquire US-based CytoSen Therapeutics, Inc. (“CytoSen”), sub­ject to Kiadis’ share­hold­er approval and cus­tom­ary clos­ing con­di­tions. 

Privately held CytoSen has devel­oped a pro­pri­etary nat­ur­al killer (NK)-cell plat­form to enable NK-cell ther­a­py with broad anti-can­cer poten­tial. It was found­ed on tech­nol­o­gy exclu­sive­ly licensed from the University of Central Florida (UCF) and fur­ther devel­oped at Nationwide Children’s Hospital (NCH). The company’s founders, includ­ing Dean Lee, Stefan Ciurea and Robert Igarashi, are lead­ing physi­cians and sci­en­tists at NCH, MDACC and UCF, respec­tive­ly. Following the trans­ac­tion, Dr. Carl June, a pio­neer in the devel­op­ment of CAR T-cell ther­a­py and cur­rent sci­en­tif­ic advi­sor to CytoSen, will join Kiadis’ Scientific Advisory Board.

The trans­ac­tion cre­ates a leader in cell-based can­cer immunother­a­py. The com­bined com­pa­ny has a com­ple­men­tary devel­op­ment pipeline focused on improv­ing out­comes for patients under­go­ing hematopoi­et­ic stem cell trans­plants (HSCT). Kiadis’ lead T-cell prod­uct ATIR101 is in EU reg­is­tra­tion and a glob­al Phase 3 clin­i­cal tri­al;  CytoSen’s lead NK-cell prod­uct can­di­date, CSDT002-NK, build­ing on promis­ing clin­i­cal proof-of-con­cept stud­ies in 25 patients car­ried out at MD Anderson Cancer Center, is expect­ed to enter the clin­ic in the US in 2020. The unique com­bi­na­tion of pro­pri­etary and syn­er­gis­tic NK-cell and T-cell ther­a­py plat­forms has the poten­tial to rev­o­lu­tion­ize HSCT and enables Kiadis to cre­ate a pipeline with nov­el can­cer treat­ments. 

Arthur Lahr, CEO of Kiadis com­ment­ed: “Our vision is to lever­age the strengths of the human immune sys­tem to help patients with life-threat­en­ing dis­eases. With the addi­tion of CytoSen, we can cre­ate cell ther­a­py treat­ments that com­bine the innate and adap­tive arms of the immune sys­tem. The ATIR T-cell and CSDT002-NK-cell pro­grams each have the poten­tial to make trans­plants safer and more effec­tive. In com­bi­na­tion, they have the poten­tial to rev­o­lu­tion­ize HSCT, mak­ing it suit­able for an even wider group of patients. This trans­ac­tion will trans­form Kiadis into a unique com­pa­ny with two syn­er­gis­tic pro­pri­etary cell-based immunother­a­py plat­forms and the oppor­tu­ni­ty to cre­ate a pipeline of inno­v­a­tive treat­ments for can­cer patients.”

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, com­ment­ed: “NK-cell ther­a­py could sig­nif­i­cant­ly advance the field of immuno-oncol­o­gy. Also, I believe the fields of NK-cells and T-cells are enor­mous­ly syn­er­gis­tic and the com­bi­na­tion could poten­tial­ly help patients with dev­as­tat­ing dis­eases. I am pleased to be join­ing the Scientific Advisory Board of Kiadis.”

Dean A. Lee, MD, PhD, co-founder of CytoSen and direc­tor of the Cellular Therapy and Cancer Immunology Program at Nationwide Children’s Hospital (NCH), com­ment­ed: “CytoSen has the most advanced NK-cell tech­nol­o­gy to enable NK-cell ther­a­py with broad anti-can­cer poten­tial. The strong expe­ri­ence, infra­struc­ture, and com­pe­ten­cies of Kiadis in cell ther­a­py will accel­er­ate our deliv­ery of NK-cells to patients, and the new oppor­tu­ni­ties for explor­ing NK-cell and T-cell syn­er­gies will enable dis­rup­tive inno­va­tion in the cell ther­a­py space. I am excit­ed to col­lab­o­rate with Kiadis to bring this inno­va­tion to patients.”   

NK-cells are one of the body’s first lines of immuno­log­i­cal defense with an innate abil­i­ty to rapid­ly and selec­tive­ly destroy abnor­mal cells, such as can­cer or viral­ly-infect­ed cells. Advancing research into the biol­o­gy of NK-cells, as well as emerg­ing ear­ly-stage clin­i­cal evi­dence, has increas­ing­ly shown that NK-cell immunother­a­py has the poten­tial to be at the fore­front of can­cer immunother­a­py. CytoSen’s patent­ed nanopar­ti­cle pro­cess­ing tech­nol­o­gy enables improved ex vivo expan­sion and acti­va­tion of NK-cells sup­port­ing mul­ti­ple high dose infu­sions with potent anti-can­cer cyto­tox­i­c­i­ty. 

CytoSen’s lead pro­gram, CSTD002-NK in HSCT, is built on proof-of-con­cept stud­ies in 25 patients car­ried out at MDACC. First results of these stud­ies demon­strat­ed a relapse rate of 8% and pro­gres­sion-free sur­vival (PFS) of 66% (pub­lished in Blood[1], with fol­low up data pre­sent­ed at the American Society of Hematology (ASH) annu­al meet­ing in 2018). The upcom­ing clin­i­cal study with CSDT002-NK, expect­ed to start in 2020, has been designed with and will be sup­port­ed by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The study will enroll high-risk acute myeloid leukemia (AML) patients under­go­ing a hap­loiden­ti­cal HSCT at a con­sor­tium of lead­ing US trans­plant cen­ters in the BMT CTN net­work. Additionally, CytoSen’s NK-cell ther­a­py will be inves­ti­gat­ed for oth­er can­cer treat­ments based on an 8-patient proof-of-con­cept study con­duct­ed at MDACC in refrac­to­ry AML. 

Transaction Details:
At clos­ing, CytoSen share­hold­ers will receive upfront con­sid­er­a­tion of 1.94 mil­lion shares of Kiadis stock. The upfront con­sid­er­a­tion con­sti­tutes approx­i­mate­ly 7.4% of Kiadis’ shares out­stand­ing after the trans­ac­tion. In addi­tion, CytoSen share­hold­ers are eli­gi­ble to receive poten­tial future con­sid­er­a­tion of up to 5.82 mil­lion addi­tion­al shares of Kiadis stock upon the achieve­ment of six clin­i­cal devel­op­ment and reg­u­la­to­ry mile­stones, with the final mile­stone being first FDA approval of an NK-cell prod­uct based on CytoSen’s tech­nol­o­gy. The major­i­ty of the Kiadis shares issued to the CytoSen share­hold­ers, includ­ing to its Executive Chairman and founders, will be sub­ject to a lock-up for a peri­od of two years from clos­ing. At sign­ing, CytoSen held approx­i­mate­ly USD 6 mil­lion in net cash, which will remain in the com­bined com­pa­ny. Saola Healthcare Partners act­ed as finan­cial advi­sor to Kiadis in the trans­ac­tion.

Shareholder Approval:
The trans­ac­tion is sub­ject to the approval of Kiadis’ share­hold­ers. The Company has called an extra­or­di­nary meet­ing of share­hold­ers (EGM) to be held on Wednesday, May 29, 2019, at which the pro­pos­al sup­port­ing the trans­ac­tion will be vot­ed upon. Kiadis’ two largest share­hold­ers (funds rep­re­sent­ed by and/or affil­i­at­ed with Life Sciences Partners and Draper Esprit), togeth­er rep­re­sent­ing 31.5% of Kiadis stock, have exe­cut­ed vot­ing agree­ments in favor of the trans­ac­tion. In the event that the trans­ac­tion does not com­plete because the General Meeting with­holds its approval, CytoSen is enti­tled to a USD 1 mil­lion break fee to be paid in cash or Kiadis shares.

Kiadis Business Update:

  • Kiadis pre­vi­ous­ly sub­mit­ted a mar­ket­ing autho­riza­tion appli­ca­tion (MAA) to the EMA for ATIR101 which is cur­rent­ly under review. The Company plans to respond to the day 180 out­stand­ing issues by the end of May 2019, allow­ing for poten­tial EU approval and launch by the end of 2019.
  • The glob­al Phase 3 tri­al for ATIR101, CR-AIR-009, will com­pare ATIR101 to the post-trans­plant cyclophos­phamide (PTCy) or ‘Baltimore’ pro­to­col. Completion of enroll­ment and an inter­im analy­sis of the pri­ma­ry end­point is expect­ed in 2021.
  • Kiadis’ cash posi­tion was EUR 60.3 mil­lion as of December 31, 2018 and EUR 49.0 mil­lion as of March 31, 2019.  

Kiadis Pharma rais­es €31.2 mil­lion in a pri­vate place­ment of 3.9 mil­lion new shares

Amsterdam, The Netherlands, October 19, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announces that it has raised gross pro­ceeds of €31.2 mil­lion through a pri­vate place­ment of 3.9 mil­lion new shares to insti­tu­tion­al investors via an accel­er­at­ed book­build­ing process as announced on October 18, 2018 (the “Placing”). The Placing was com­plet­ed at a sub­scrip­tion price of €8.00 per share and rep­re­sent­ed approx­i­mate­ly 19% of the issued share cap­i­tal of the Company pri­or to the trans­ac­tion. The new ordi­nary shares will rank pari pas­su in all respects with the cur­rent­ly out­stand­ing shares of the Company and are expect­ed to be list­ed and trad­ed on Euronext Amsterdam and Euronext Brussels on October 23, 2018. Following the Placing, the issued share cap­i­tal of the Company will con­sist of 24,341,410 ordi­nary shares. Continue read­ing “Kiadis Pharma rais­es €31.2 mil­lion in a pri­vate place­ment of 3.9 mil­lion new shares”

KIADIS PHARMA PROVIDES REGULATORY AND CLINICAL UPDATE ON ATIR101

– Potential CHMP opin­ion moved from Q4 2018 into H1 2019
– Guidance for ini­tial EU com­mer­cial launch in H2 2019 unchanged
– FDA meet­ing held under RMAT sta­tus
– Phase 3 study on track with over 20 open sites expect­ed by end 2018, of which sev­er­al in US

Amsterdam, The Netherlands, October 12, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announces a reg­u­la­to­ry and clin­i­cal update for ATIR101.

Europe EMA
Following recent meet­ings of the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), Kiadis Pharma received a Day 180 sec­ond List of Outstanding Issues relat­ing to its mar­ket­ing autho­riza­tion appli­ca­tion (MAA) for ATIR101. Kiadis Pharma has com­plet­ed its eval­u­a­tion of these remain­ing Day 180 ques­tions. Addressing the ques­tions will require addi­tion­al analy­ses of exist­ing clin­i­cal data. As expect­ed, no new exper­i­men­tal or new clin­i­cal data needs to be gen­er­at­ed. EMA has accept­ed the Company’s request for the time need­ed to respond to the remain­ing ques­tions. As a result, the tim­ing of the expect­ed CHMP opin­ion has moved from the fourth quar­ter of 2018 into the first half of 2019. Following poten­tial EU approval, which typ­i­cal­ly fol­lows a pos­i­tive CHMP Opinion with­in 67 days, Kiadis Pharma intends to com­mer­cial­ly launch ATIR101 in a first EU mem­ber state in the sec­ond half of 2019, which is unchanged ver­sus pre­vi­ous guid­ance.

US FDA
In 2017, the US Food and Drug Administration (FDA) grant­ed ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) des­ig­na­tion. Similar to a Breakthrough Therapy des­ig­na­tion, RMAT sta­tus allows com­pa­nies devel­op­ing regen­er­a­tive med­i­cine ther­a­pies to inter­act with the FDA more fre­quent­ly, and RMAT-des­ig­nat­ed prod­ucts may be eli­gi­ble for pri­or­i­ty review and accel­er­at­ed approval. As part of its RMAT sta­tus, Kiadis Pharma is ben­e­fit­ting from pro­duc­tive inter­ac­tions with the US FDA, includ­ing a recent meet­ing.

Phase 3 clin­i­cal tri­al
The Company is on track with the ongo­ing Phase 3 clin­i­cal study to enroll 250 patients at lead­ing trans­plant cen­ters glob­al­ly. The Company has now enrolled 22 patients and has 14 sites open in 7 coun­tries. Kiadis Pharma expects to have over 20 sites open by the end of 2018, includ­ing sev­er­al US sites. An inter­im analy­sis of the Phase 3 study is expect­ed in the sec­ond half of 2020. Continue read­ing “KIADIS PHARMA PROVIDES REGULATORY AND CLINICAL UPDATE ON ATIR101”