16 March 2017
Kiadis Pharma to present information on the design of its Phase III trial with ATIR101™ and Phase I/II trial with ATIR201™ at 43rd Annual Meeting of the European Society for Blood
Additionally, Kiadis Pharma will host a Satellite Symposium entitled: “Advances in Haploidentical Stem Cell Transplantation and Post-Transplant Immunotherapy”
Amsterdam, The Netherlands, March 16, 2017, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS),a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that abstracts providing information on the design of the Company’s recently initiated Phase III clinical trial with lead product ATIR101™ and Phase I/II clinical trial with ATIR201™, have been accepted for poster presentation on March 27 and 28, 2017 respectively at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Marseille, France.
In addition, Kiadis Pharma will host a satellite symposium on March 26, 2017 entitled: “Advances in Haploidentical Stem Cell Transplantation and Post-Transplant Immunotherapy”. The symposiumwill be chaired by Dr. Hermann Einsele, Professor at the University Hospital of the Julius-Maximilians-University, Würzburg, Germany and he will be joined by several other international key opinion leaders in the field of hematopoietic stem cell transplantation. The symposium will provide an update on recent developments in haploidentical stem cell transplantation, including post-transplant Cyclophosphamide, T-cell depletion methodologies and use of immunotherapy approaches after transplantation, such as ATIR101™. Presentations will be given by Prof. Arnon Nagler of the Chaim Sheba Medical Center, Tel-Hashomer, Israel; Prof. Leo Luznik of the Johns Hopkins University School of Medicine, Baltimore, USA; Prof. Stephan Mielke of the University Hospital, Würzburg, Germany; and Prof. Denis-Claude Roy of the Maisonneuve-Rosemont Hospital, Montreal, Canada. The full program is available on http://www.ebmt2017.org/kiadis
Date: Monday March 27, 2017 from 9:00 - 18:30 CET
Title: Introduction of the HATCY study: A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101 with post-transplant cyclophosphamide in patients with a hematologic malignancy
Date: Tuesday March 28, 2017 from 9:00 - 18:00 CET
Title: An exploratory, open-label study to evaluate the safety and feasibility of ATIR201, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), as adjuvant treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation in patients with beta-thalassemia major
Full abstracts are available on the EBMT website and onthe Company’s website. In addition, the abstracts will be published in the supplement edition of Bone Marrow Transplantation.
Date: Sunday March 26, 2017 from 11.00 - 12.30 CET
Room: Les Goudes 2
Title: Advances in Haploidentical Stem Cell Transplantation and Post-Transplant Immunotherapy
Speakers: Prof. Arnon Nagler (Chaim Sheba Medical Center, Tel-Hashomer, Israel), Prof. Leo Luznik (Johns Hopkins University School of Medicine, Baltimore, USA), Prof. Stephan Mielke (University Hospital, Würzburg, Germany) and Prof. Denis-Claude Roy (Maisonneuve-Rosemont Hospital, Montreal, Canada).
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harboring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will help fight infections and remaining tumor cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. 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, known as the Graft-versus-Leukemia (GVL) effect.
ATIR101™, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumor cells but that do not cause GVHD. ATIR101™ thus has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and residual tumor cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
On December 5, 2016 at the Annual Meeting of the American Society of Hematology (ASH), the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data showed that ATIR101™ significantly reduced Transplant Related Mortality and significantly improved Overall Survival. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient. Based on these positive results, a Phase III clinical trial has been initiated. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ Phase I/II clinical development has been initiated recently.
Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.com
Manfred Rüdiger, CEO
1114 AA Amsterdam-Duivendrecht
International Media and Investor Contact:
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Consilium Strategic Communications
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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.