Last patient dosed with ATIR101™ in the Phase II ‘008’ clin­i­cal tri­al

– Results from the sin­gle dose 1-year fol­low up con­sis­tent with pri­or Phase II study
– Data sup­ports already sub­mit­ted mar­ket­ing autho­riza­tion appli­ca­tion

Amsterdam-Duivendrecht, The Netherlands, January 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell ther­a­py prod­ucts aim­ing to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that the last patient in the Phase II CR-AIR-008 (‘008’) tri­al has received a sin­gle dose of ATIR101™.
This explorato­ry Phase II tri­al (clinicaltrials.gov iden­ti­fi­er: NCT02500550) was designed to eval­u­ate the safe­ty and effi­ca­cy of two dos­es of ATIR101™ in patients with a hema­to­log­ic malig­nan­cy who received a hematopoi­et­ic stem cell trans­plan­ta­tion from a hap­loiden­ti­cal (half-matched) donor.
A total of 15 patients were recruit­ed into the tri­al. Six of these patients received two dos­es of ATIR101™ before the inde­pen­dent data mon­i­tor­ing com­mit­tee (IDMC) rec­om­mend­ed that the tri­al should con­tin­ue treat­ing patients with one dose of ATIR101™ (announced on December 21, 2016). The remain­ing nine patients on the tri­al have now been treat­ed with a sin­gle dose of ATIR101™. Of these nine patients, five patients are 1-year post treat­ment and results are con­sis­tent with the pre­vi­ous­ly con­duct­ed 23-patient CR-AIR-007 sin­gle dose Phase II tri­al. More… »

Kiadis Pharma pro­pos­es for­mer Cipla CEO Subhanu Saxena as new Supervisory Board mem­ber

Amsterdam-Duivendrecht, The Netherlands, January 16, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell ther­a­py prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that at its next General Meeting of Shareholders, the Kiadis Pharma Supervisory Board will nom­i­nate Subhanu Saxena to be appoint­ed as a new mem­ber of the Supervisory Board.
Subhanu Saxena is cur­rent­ly a Regional Director with The Bill & Melinda Gates Foundation as well as part­ner New Rhein Healthcare and Senior Advisor to Bain Capital. He was, until recent­ly, the Managing Director and Global Chief Executive Officer of Cipla, a pub­licly list­ed, lead­ing Indian phar­ma­ceu­ti­cal and biotech com­pa­ny with glob­al oper­a­tions and around 25,000 employ­ees. During Mr. Saxena’s lead­er­ship Cipla was trans­formed into a more inter­na­tion­al and agile com­pa­ny. Prior to join­ing Cipla, Mr. Saxena was Head of Global Product Strategy and Commercialization and mem­ber of the Executive Committee at Novartis. Before that, Mr. Saxena was CEO of Novartis UK and held var­i­ous lead­er­ship roles in busi­ness devel­op­ment. Prior to join­ing the phar­ma indus­try Mr. Saxena worked with lead­ing glob­al com­pa­nies includ­ing Citicorp, the Boston Consulting Group and PepsiCo across mar­kets in Europe, North America, Africa and Asia. Mr. Saxena holds a Graduate degree in Engineering from Oxford University and an MBA from INSEAD, France. More… »

Kiadis Pharma to lease exist­ing com­mer­cial man­u­fac­tur­ing facil­i­ty in The Netherlands

Amsterdam-Duivendrecht, The Netherlands, December 6, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell ther­a­py prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that it has entered into an agree­ment to lease an exist­ing com­mer­cial man­u­fac­tur­ing facil­i­ty, which includes process devel­op­ment and qual­i­ty con­trol lab­o­ra­to­ries, as well as space for the Kiadis Pharma head­quar­ters in Amsterdam, The Netherlands. The facil­i­ty is locat­ed at Paasheuvelweg 25A in Amsterdam, The Netherlands.
The in-house man­u­fac­tur­ing capa­bil­i­ty will allow the Company to enhance flex­i­bil­i­ty and expand capac­i­ty, and will not affect the ongo­ing con­tract man­u­fac­tur­ing col­lab­o­ra­tions.
Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “As we con­tin­ue to pre­pare for European launch in 2019, this pro­vides Kiadis with a unique oppor­tu­ni­ty to obtain access to a recent­ly estab­lished state-of-the-art com­mer­cial man­u­fac­tur­ing facil­i­ty in Amsterdam with­out spend­ing cap­i­tal and time on a con­struc­tion project. Also, we can now locate all our activ­i­ties at a sin­gle site.
More… »

First patient enrolled in Phase 3 tri­al for ATIR101™ in adult patients with blood can­cer

Amsterdam-Duivendrecht, The Netherlands, December 4, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell-ther­a­py prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients, today announces that the first patient has been enrolled in the HATCY Phase 3 clin­i­cal tri­al for ATIR101™.
The multi­na­tion­al tri­al will eval­u­ate the safe­ty and effi­ca­cy of ATIR101™ as an adjunc­tive treat­ment to blood stem cell trans­plan­ta­tion from a half-matched (hap­loiden­ti­cal) fam­i­ly donor com­pared to post-trans­plant cyclophos­phamide (PTCy or ‘Baltimore’ pro­to­col) in adult patients with blood can­cer.
Andrew Sandler, Chief Medical Officer of Kiadis Pharma, com­ment­ed: “We are pleased that the first patient has been enrolled in the Phase 3 tri­al for our inno­v­a­tive cell-ther­a­py prod­uct ATIR101™. Although the ‘Baltimore’ pro­to­col has made hap­loiden­ti­cal trans­plants fea­si­ble, a huge unmet need remains due to high relapse rates and occur­rence of graft ver­sus host dis­ease.
Arthur Lahr, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “The start of this large multi­na­tion­al Phase 3 clin­i­cal tri­al marks anoth­er impor­tant step in the devel­op­ment of Kiadis. We aim to sub­mit the results from this Phase 3 tri­al to the US FDA, while we con­tin­ue to progress the European fil­ing sub­mit­ted ear­li­er this year to EMA based on our Phase 2 data.
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Kiadis Pharma rais­es €18.0 mil­lion in a pri­vate place­ment of 2.25 mil­lion new shares

Amsterdam-Duivendrecht, The Netherlands, October 10, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients suf­fer­ing from blood can­cers and inher­it­ed blood dis­or­ders, today announces that it has raised gross pro­ceeds of €18 mil­lion through an undoc­u­ment­ed pri­vate place­ment of 2.25 mil­lion new shares to insti­tu­tion­al investors via an accel­er­at­ed book­build­ing process as announced on October 9, 2017 (the “Placing”). The Placing was com­plet­ed at a sub­scrip­tion price of €8.00 per share and rep­re­sent­ed 15.0% 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 Brussels on October 12, 2017. Following the Placing, the issued share cap­i­tal of the Company will be 17,287,397.
The pro­ceeds from the Placing, com­bined with €2.3 mil­lion received by Kiadis Pharma from the exer­cise of war­rants placed pur­suant to the Company’s pri­vate place­ment of June 13, 2017, will allow the com­pa­ny to draw down an addi­tion­al €5 mil­lion of debt financ­ing from Kreos Capital as announced on August 17, 2017. More… »