Amsterdam, The Netherlands, April 7, 2016 – 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 at its next General Meeting of Shareholders, the Kiadis Pharma Supervisory Board will nominate Dr. Robert Soiffer and Mr. Berndt Modig to be appointed as new members of the Supervisory Board.
Dr. Robert Soiffer has worked in professional medical practice for more than 30 years, specifically in the field of hematologic malignancies and stem cell/bone marrow transplantations. Dr. Soiffer is Professor of Medicine at the Harvard Medical School, Chief of the Division of Hematologic Malignancies at the Dana-Farber Cancer Institute (which is part of the Harvard Medical School) and Co-director of the Adult Stem Cell Transplantation Program at the Dana-Farber Cancer Institute. Dr. Soiffer is Chair Elect of the Advisory Committee of the Center for International Blood and Marrow Transplant Research (CIBMTR), serves on the Board of Directors for the National Marrow Donor Program Be the Match Registry and has served as President of the American Society of Blood and Marrow Transplantation (ASBMT). Dr. Soiffer graduated from the New York University School of Medicine and completed his residency in internal medicine at Brigham and Women's Hospital where he was also Chief Medical Resident before joining the Dana-Farber Cancer Institute, after completing a medical oncology fellowship.
Mr. Berndt Modig has more than 30 years of professional international experience in finance, including operations management and audit committee roles. He has served as Chief Financial Officer of Prosensa Holding N.V. and as Chief Financial Officer at Jerini AG. Mr. Modig is currently serving on the boards of Axovant Sciences Ltd., Auris Medical AG and Affimed N.V. and is CEO of Pharvaris B.V. Mr. Modig holds a bachelor’s degree in business administration, economics and German from the University of Lund, Sweden and an M.B.A. degree from INSEAD, Fontainebleau, France and is a Certified Public Accountant.
Mark Wegter, Chairman of the Supervisory Board of Kiadis Pharma, commented: “We are delighted to welcome both Robert and Berndt to our Supervisory Board. They are both highly respected, well connected professionals with very relevant experience. Their expertise gained from working within the biotechnology and pharmaceutical sectors across both Europe and the US will be invaluable to Kiadis Pharma as we continue to build momentum following the recent announcement of positive results on the primary endpoint of our Phase II trial with our lead product ATIR101™.”
About ATIR101™
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, harbouring 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 tumour 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, minimising 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.
Therefore, 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 tumour 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 tumour 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 a clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), being graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders and the Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
In April 2016, the Company reported positive results on the primary endpoint of its single dose Phase II trial with ATIR101™. The study was designed as an open-label trial in patients with blood cancer who had not found a matching donor and where a partially matched (haploidentical) family member was used as donor for HSCT. The primary endpoint of the trial was Transplant Related Mortality (TRM) within six months-post HSCT. The data confirmed that ATIR101™ can be safely infused, does not cause grade III-IV GVHD and shows a significant reduction in TRM and a significant improvement in Overall Survival (OS) in comparison to a historical control group of patients undergoing a T-cell depleted haploidentical donor transplantation only.
In addition, the Company is enrolling blood cancer patients in a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to further improve the HSCT outcome.
The European Medicines Agency (EMA) has issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data to the Company, and to date Kiadis Pharma is one of only five companies that have received such a certificate.
ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
ATIR201™ will be developed for inherited blood disorders with an initial focus on thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter Phase I/II clinical development for thalassaemia in the first quarter of 2016. Kiadis Pharma recently announced a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia.
Kiadis Pharma is based in Amsterdam, the Netherlands and its shares are listed on Euronext Amsterdam and Euronext Brussels. Further information can be found at: 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.