Home News First patient enrolled in Phase…

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.”

About the HATCY Phase 3 trial
This Phase 3 trial (ClinicalTrial.gov identifier: NCT02999854; EudraCT number: 2016-004672-21; Kiadis number: CR-AIR-009; Kiadis name: HATCY) will enroll 195 patients in Europe, US and Canada. The primary objective of this randomized, open label, parallel arm Phase 3 trial is to compare safety and efficacy of a haploidentical (half-matched family donor) T-cell depleted hematopoietic stem-cell transplant (HSCT) and adjunctive treatment with ATIR101™ versus a haploidentical T-cell replete HSCT with post-transplant administration of high dose cyclophosphamide in adult patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). The primary composite endpoint is graft-versus-host disease free and relapse-free survival (GRFS), secondary endpoints include overall survival (OS). An additional objective of the study is to compare the effect of the two treatments on quality of life and health economics. The study is event driven and the primary analysis will be performed after 93 GRFS event.

About Kiadis Pharma
Kiadis Pharma’s cell-based immunotherapy products can make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective. Single dose Phase 2 data with lead product ATIR101™ in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the EU as an adjunctive treatment in HSCT for malignant disease. Kiadis Pharma received Day 120 questions in September 2017 and is on track for potential (conditional) approval in H2 2018 and launch in 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101™ across Europe and North America (head to head against the Baltimore protocol). The first patient was enrolled in December 2017.

In September 2017 the US Food and Drug Administration (FDA) granted ATIR101™ the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.

The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.

Website: www.kiadis.com

Company presentation: http://www.kiadis.com/company-presentation/

For more information, please contact:

Kiadis Pharma:
Karl Hård
Head of IR & Communications
Tel. +31 611 096 298
k.hard@kiadis.com 

or

 

 

Consilium Strategic Communications:
Mary-Jane Elliott, Philippa Gardner, Lindsey Neville, Hendrik Thys
Tel: +44 203 709 5708
kiadis@consilium-comms.com

 

Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.