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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.

KIADIS UPDATES STATUS OF MARKETING AUTHORIZATION APPLICATION FOR ATIR101

28.JUNE 2019 AT 18:10:51 CET

Kiadis updates sta­tus of mar­ket­ing autho­riza­tion appli­ca­tion for ATIR101

Amsterdam, The Netherlands, June 28, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has received feed­back from the European Medicines Agency (EMA) relat­ed to the mar­ket­ing autho­riza­tion appli­ca­tion (MAA) seek­ing approval of ATIR101 in hematopoi­et­ic stem cell trans­plant (HSCT). As pre­vi­ous­ly announced, Kiadis sub­mit­ted respons­es to the sec­ond Day 180 list of out­stand­ing issues for ATIR101 to EMA in May 2019.  

As part of the review process, EMA today informed Kiadis that it will con­vene a Scientific Advisory Group (SAG) in September, com­pris­ing of experts in hema­tol­ogy and HSCT to assist EMA in arriv­ing at a deter­mi­na­tion. 

“We appre­ci­ate the feed­back from EMA and look for­ward to con­tin­u­ing our inter­ac­tion with them dur­ing the review of our MAA for ATIR101,” said Arthur Lahr, CEO, of Kiadis Pharma. “With the SAG meet­ing now pre­ced­ing the sub­se­quent CAT and CHMP meet­ings as part of the EMA approval process, we are chang­ing our guid­ance to poten­tial EU con­di­tion­al approval in 2020.”

While ini­tial launch in the EU is delayed, Kiadis is on track to com­plete enroll­ment in the Phase 3 ATIR101 HSCT study in 2021 to sup­port poten­tial mar­ket­ing approval in the US. Additionally, the com­pa­ny is  also on track to start the Phase 1/2 stud­ies of CSDT002 in HSCT and relapse and refrac­to­ry acute myeloid leukemia in 2020. With a nov­el cell-based can­cer immunother­a­py plat­form con­sist­ing of both T-cell and NK-cell tech­nolo­gies, Kiadis has the oppor­tu­ni­ty to poten­tial­ly rev­o­lu­tion­ize trans­plants and devel­op nov­el can­cer cell ther­a­pies.

KIADIS PHARMA COMPLETES ACQUISITION OF CYTOSEN THERAPEUTICS, INC.

06.JUNE 2019 AT 07:30:00 CET

Amsterdam, The Netherlands, June 6, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announces that it has closed the pre­vi­ous­ly announced acqui­si­tion of CytoSen Therapeutics, Inc. (“CytoSen”). 

The trans­ac­tion cre­ates a leader in cell-based can­cer immunother­a­py with pro­pri­etary and syn­er­gis­tic NK-cell and T-cell ther­a­py plat­forms that have the poten­tial to rev­o­lu­tion­ize HSCT and cre­ate a pipeline with nov­el can­cer treat­ments. Kiadis now has a com­ple­men­tary devel­op­ment pipeline focused on improv­ing out­comes for patients under­go­ing hematopoi­et­ic stem cell trans­plants (HSCT) with a T-cell ther­a­py (ATIR101; in EU reg­is­tra­tion and a glob­al Phase 3 clin­i­cal tri­al) and a NK-cell ther­a­py (CSTD002; expect­ed to enter the clin­ic in the US in 2020).

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 and through this acqui­si­tion we can now cre­ate nov­el cell ther­a­pies that com­bine the innate and adap­tive arms of the immune sys­tem. This trans­ac­tion is trans­for­ma­tive for Kiadis as we now have two syn­er­gis­tic pro­pri­etary cell-based immunother­a­py plat­forms and the abil­i­ty to cre­ate a pipeline of inno­v­a­tive treat­ments for can­cer patients.”

Total upfront con­sid­er­a­tion paid to the hold­ers of CytoSen shares and options on clos­ing con­sists of 1,513,052 new­ly issued Kiadis shares and 159,778 options to acquire Kiadis shares. Upon accep­tance by afore­men­tioned par­ties of the shares issued to them, the new­ly issued Kiadis shares shall be admit­ted to trad­ing on Euronext Amsterdam and Euronext Brussels on the basis of the list­ing prospec­tus with­in the mean­ing of Directive 2003/71/EC, as amend­ed and Directive 2010/73/EU con­sist­ing of the reg­is­tra­tion doc­u­ment approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiële Markten, “AFM”) dat­ed May 31, 2019 and the sum­ma­ry and secu­ri­ties note approved by the AFM dat­ed May 31, 2019 that have been made gen­er­al­ly avail­able. Of the 1,513,052 new­ly issued Kiadis shares, 874,129 shares (57.8%) are sub­ject to lock-up restric­tions dur­ing a two-year peri­od, and the oth­er 638,923 shares (42.2%) are sub­ject to lock-up restric­tions dur­ing a 180-day peri­od. 

Further to the above­men­tioned 1,513,052 new­ly issued Kiadis shares, the hold­ers of CytoSen shares have a con­di­tion­al enti­tle­ment to receive 267,012 new­ly issued Kiadis shares – the Holdback Shares as defined in the list­ing prospec­tus. The Holdback Shares serve as a source for the sat­is­fac­tion of indem­ni­fi­ca­tion and oth­er claims that Kiadis may have on the CytoSen share­hold­ers pur­suant to the acqui­si­tion agree­ment. Subject to reduc­tion in respect of these indem­ni­fi­ca­tion and oth­er claims, the Holdback Shares will be issued 18 months from the com­ple­tion date. Also, as per the acqui­si­tion agree­ment, the hold­ers of CytoSen shares and options are eli­gi­ble to poten­tial future con­sid­er­a­tion of up to 5,819,460 addi­tion­al Shares upon the achieve­ment of six clin­i­cal devel­op­ment and reg­u­la­to­ry mile­stones.

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.”