One Year Data From Kiadis Pharma's Ongoing Phase II Trial With ATIR101 Will Be Presented At American Society of Hematology 2016 Annual Meeting
11/3/2016 8:52:15 AM
Amsterdam, The Netherlands, November 3, 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 data from the Company’s ongoing Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™ has been selected by the American Society of Hematology (ASH) Program Committee for an oral presentation at the 58th Annual Meeting in San Diego, California on December 5, 2016.
The abstract will be presented by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and one of the principal investigators for the trial, and will provide one year data from Kiadis Pharma’s international multi-center study, in which a total of 23 leukemia patients, including patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS), have been enrolled to be treated with ATIR101™ as part of their transplant regimen. In addition, the abstract includes a comparison to a historic control group.
Abstract title: Donor Lymphocytes Depleted of Alloreactive T-Cells (ATIR101) Improve Event-Free Survival (GRFS) and Overall Survival in a T-Cell Depleted Haploidentical HSCT: Phase 2 Trial in Patients with AML and ALL
Date: Monday, December 5, 2016 from 6:15 to 7:45 PM Eastern Daylight Time (EDT) (presentation time: 6:30 PM EDT)
Session: 711. Cell Collection and Processing: Immunotherapy, Immunomodulation and Immune Reconstitution
Location: San Diego Convention Center, Room 30
The full abstract is available to view online at www.hematology.org later today at 9:00 AM EDT. In addition, the abstract will be published online in the December 1, 2016 supplemental volume of Blood.
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.
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 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.
In April 2016, 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. A Phase III clinical trial with ATIR101™ is expected to be initiated in the second half of 2016. 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™ is expected to enter Phase I/II clinical development in the second half of 2016.
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
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