AMSTERDAM--(BUSINESS WIRE)--Regulatory News:
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 for patients suffering from blood cancers and inherited blood disorders safer and more effective, today announced it will host a Key Opinion Leader meeting on the topic of ‘Addressing the Risks of Haploidentical HSCT in Blood Cancer’ on Wednesday, May 31 from 12:00pm - 1:30pm Eastern Time in New York City.
The meeting will feature presentations by key opinion leaders Steven Devine, MD (Ohio State University) and Denis-Claude Roy, MD (University of Montréal), who will discuss the risks of haploidentical hematopoietic stem cell transplantation (HSCT) in blood cancer, specifically Graft-versus-Host-Disease (GVHD) and cancer relapse, with the PTCy/ Baltimore protocol and T-cell depleted transplantations. Both KOLs will be available to answer questions following the lunch meeting.
Kiadis Pharma’s management team will provide an update on their lead asset ATIR101, currently in EMA registration and Phase III clinical development for patients with acute leukemia. Orphan drug ATIR101, administered as an adjunctive immunotherapy after a haploidentical HSCT, contains potent, allo-depleted, mature immune cells from a haploidentical donor, that provide immediate protection against relapse, with minimal risk of causing GVHD.
Steven Devine, MD, is Professor of Internal Medicine in the Division of Hematology and Director of the Blood and Marrow Transplant Program at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. Dr. Devine is currently Chair of the National Cancer Institute-funded Alliance Transplant Committee as well as Chair of the NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Steering Committee. He is the Principal Investigator of The Ohio State Consortium; one of the 20 core members within the BMT CTN. He is the 2017 Track leader in Leukemia, myelodysplastic syndrome, and transplantation educational sessions at the American Society of Clinical Oncology (ASCO) annual meeting and co-authored the 2017 ASCO Cancer Clinical Advances position paper. He has a major research interest in the application of stem cell transplantation for patients with acute leukemia and non-Hodgkin’s lymphoma and has served as Chair of two multi-center NIH-supported clinical transplantation trials in AML. He also has a major interest in novel methods to prevent graft versus host disease. He has written or co-written more than 200 peer-reviewed papers and more than 350 abstracts as well as several reviews and book chapters in the field of stem cell transplantation, leukemia, and hematology and he has served as a reviewer for several journals, including Blood, New England Journal of Medicine, Nature Medicine, Journal of Clinical Oncology, Haematologica, Biology of Blood and Marrow Transplantation, and Bone Marrow Transplantation.
Denis-Claude Roy, MD, is a practicing physician in the Division of Hematology and Bone Marrow Transplantation at the Maisonneuve-Rosemont Hospital, a Professor of Medicine at the University of Montréal, Director of Research – East of Montreal, and Scientific Director, Center of Excellence for Cell Therapy, in Montréal, Canada. His research interests focus on the immunobiology of stem cell transplantation, and particularly at the treatment of cell grafts to promote stem and progenitor cell expansion, foster immunotolerance and develop immune therapies against cancer. He has chaired 15 Phase I-II clinical trials at the national and international level. He has published more than 100 original articles and book chapters in journals such as Cell, Science, PLoS Medicine, Nature Medicine and Blood. Dr. Roy is Director of the Clinical Therapeutics Arm of the Canadian Stem Cell Network, Co-Director of the ThéCell FRSQ Network, and former member of the Canadian Blood and Marrow Transplant Group board and Executive Committee of the National Cancer Institute of Canada-CTG-Hematology. He is member of the Board of directors of the Stem Cell Foundation. He is also CEO of CellCAN Regenerative Medicine and Cell Therapy Network (Network of Centres of Excellence), and Chief Scientific Officer of the Centre for Commercialization of Cancer Immunotherapy (C3i). He is currently Director of Research for East-of-Montreal-CIUSSS, and Scientific Director of the Center of Excellence in Cellular Therapy (CETC), Hospital Maisonneuve-Rosemont.
This lunch event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. A live and archived webcast of the event, with slides, will be available at on the investors section of the Company’s website at www.kiadis.com and http://lifesci.rampard.com/20170531/reg.jsp.
For patients suffering from blood cancers and inherited blood disorders, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as a potentially curative approach. During an HSCT treatment, the patient’s diseased blood and immune system are destroyed and subsequently replaced by a healthy system from a donor. The treatment is, however, very risky as it usually takes the patient at least six to twelve months to recover to near-normal immune cell functions, making patients highly vulnerable to infections and disease relapse. Mature lymphocytes in the donor graft would provide immediate protection, but, depending on the level of genetic mismatch between patient and donor, may cause life threatening Graft-versus-Host-Disease (GVHD).
The Company estimates that approximately 35% of patients who are eligible and in urgent need of an HSCT will not find an adequately matched donor in time. A half-matched (haploidentical) parent or child, however, could serve as a donor for nearly all patients, yet would cause severe GVHD due to the infusion of half-matched mature lymphocytes. The therapy Kiadis Pharma is developing would enable the use of haploidentical transplants without the unacceptable risk of GVHD.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a safe single dose donor lymphocyte infusion (DLI) with functional, mature immune cells from a haploidentical family member with minimal risk of causing severe GVHD. ATIR101™ will help fight infections and remaining tumor cells and thereby bridge the time until the patient’s immune system has fully re-grown from stem cells in the transplanted graft.
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 product candidates, ATIR101™ for blood cancers and ATIR201™ for inherited blood disorders, have the potential to make allogeneic hematopoietic stem cell transplantations (HSCT) safer and more effective.
Based on the significant and positive results from the single dose Phase II trial with lead product ATIR101™ in patients with blood cancer, which were presented on December 5, 2016 at the Annual Meeting of the American Society of Hematology (ASH), the Company has initiated a Phase III trial with ATIR101™, having received regulatory approval in various countries to start dosing patients. In addition, and based on the positive Phase II results, the Company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ATIR101™ across Europe as an adjunctive treatment in HSCT for malignant disease . 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. ATIR201™ Phase I/II clinical development has been initiated recently with regulatory approvals having been received in various European countries to start the trial.
Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA. The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.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.