Kiadis Pharma announces abstracts and presentations for the 60th American Society of Hematology (ASH) Annual Meeting

Amsterdam, The Netherlands, November 7, 2018 - Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announces two data presentations at the 60th American Society of Hematology (ASH) Annual Meeting. The event will be held December 1-4, 2018, at the San Diego Convention Center in San Diego, CA.

Abstract 120: Efficacy and Safety of a Single Dose of Donor Lymphocytes Depleted of Alloreactive T-Cells (ATIR101) Following T-Cell-Depleted Haploidentical HSCT: A Pooled Analysis of Two Phase II Studies
Type: Oral
Session: 711. Cell Collection and Processing I
Authors: Denis-Claude Roy et al.
Date & Presentation time: Saturday, December 1, 2018, 10:45 AM
Location: Grand Hall A (Manchester Grand Hyatt San Diego)

Background: An ex vivo photodepletion method has been developed to produce ATIR101 (Kiadis Pharma), a donor lymphocyte infusion (2.0 million cells/kg) administered after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) to aid immune reconstitution. ATIR101 is depleted of alloreactive T-cells and early administration after T-cell-depleted haplo-HSCT has the potential to reduce serious complications resulting from delayed immune reconstitution, such as infections, malignant relapse, and severe graft-versus-host disease (GVHD) in the recipient. The safety and efficacy of a single dose of ATIR101 are presented here in a pooled analysis of two phase II clinical trials: CR-AIR-007 (NCT01794299) & CR-AIR-008 (NCT02500550).

Abstract 3474:  Depletion of Alloreactive T Cells after Haploidentical HSCT: Comparison of Outcomes for Ex Vivo Versus In Vivo Treatment Strategies
Type: Poster
Session: 732. Clinical Allogeneic Transplantation
Authors: Steven Devine et al.
Date & Presentation time: Sunday, December 2, 2018, 6:00 PM-8:00 PM
Location: Hall GH (San Diego Convention Center)

Background: The use of haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) has increased owing to therapeutic advances that have mitigated the main barriers such as high incidence of graft-versus-host disease (GVHD) and non-relapse mortality (NRM). Such T-cell depletion can be performed in vivo early after T-cell-replete haplo-HSCT using post-transplant cyclophosphamide (PTCy). Alternatively, T-cell-depleted haplo-HSCT can be supplemented with T-lymphocytes that are depleted ex vivo of their alloreactive component in the form of ATIR101 (Kiadis Pharma). Although ATIR101 requires cell manufacturing and is more expensive, it limits toxicity to the patient, enables haplo-HSCT without the use of immunosuppressants, and may reduce relapse rates. Both strategies are promising, but no attempt has yet been made to compare clinical results in similar patient populations to delineate key features of alloreactive T-cell depletion performed either ex vivo or in vivo.

For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of Investor Relations & Communications
Tel. +31 611 096 298
k.hard@kiadis.com
Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
kiadis@optimumcomms.com

 

About Kiadis Pharma
Kiadis Pharma is developing its lead product candidate, ATIR101, for use in conjunction with haploidentical (genetically half-matched) hematopoietic stem-cell transplantations (HSCT) for adult blood cancers to address key limitations of haploidentical HSCT, without prophylactic immunosuppression and its associated morbidity and mortality. Based on the positive results from the single dose Phase 2 CR-AIR-007 study, the Company submitted a marketing authorization application to the European Medicines Agency in April 2017 for approval of ATIR101 as an adjunctive treatment in haploidentical HSCT for high risk adult hematological malignancies. If the product is conditionally approved, Kiadis Pharma intends to launch ATIR101 through its own commercial organization in a first EU member state in the second half of 2019.

In December 2017, Kiadis Pharma commenced an international, multicenter, randomized and controlled Phase 3 clinical trial of ATIR101 against the Post-Transplant Cyclophosphamide, (PTCy) protocol, the main protocol used to perform a haploidentical HSCT. The trial will be performed in 250 patients with acute leukemia and myelodysplastic syndrome at approximately 50 sites in the United States, Canada, Europe and certain additional countries. ATIR101 received regenerative medicine advanced therapy (RMAT) designation from the FDA in September 2017, which provides benefits that are materially equivalent to a Breakthrough Therapy designation from the FDA. In addition, ATIR101 has been granted multiple orphan drug designations both in the European Union and the United States.

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

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, regulation, 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.




This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Kiadis Pharma N. V. via Globenewswire