Amsterdam, The Netherlands, March 24, 2014; Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, today announces that it will organize a satellite symposium on March 30, 2014 at the 40th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Milan, Italy.
The satellite symposium hosted by Kiadis Pharma is entitled: “Effective T-cell immunotherapy with ATIR after haploidentical HSCT: Excellent OS with low GvHD” and will take place on Sunday March 30 from 16.00-18.00 CET in Room Space 4.
The event will be chaired by Dr. Armand Keating, Professor of Medicine at the University of Toronto, Canada. Dr. Keating is past president of the American Society of Hematology (ASH) and the American Society for Blood and Marrow Transplantation (ASBMT). The speakers are respected key opinion leaders in the field of haploidentical stem cell transplantation and selective photodepletion: Professor Irwin Walker (Hamilton, Canada), Professor Stephan Mielke (Würzburg, Germany), Professor Denis-Claude Roy (Montreal, Canada), Dr. Robert Preti (Allendale, USA) and Professor John Barrett (Bethesda, USA).
The program includes an overview of current challenges of alternative donor transplantations, how selective photodepletion can overcome these challenges, and what the potential of ATIR is in relation to alternative transplantation strategies using the preliminary results of the ongoing Phase II clinical study. Additionally, the application of Quality by Design during process development of ATIR will be discussed, and how this resulted in stable and robust ATIR manufacturing.
ATIR is a T‑cell based medicinal product enabling stem cell transplantations using partially mismatched (haploidentical) family members as donors for patients suffering from blood cancer who do not have a standard of care stem cell donor available. A hematopoietic stem cell transplantation (HSCT) is the only potentially curative option for many patients but a matching donor is available for only half of the patients in need. ATIR thus has the potential to address this unmet need and to make an HSCT available for all patients worldwide.
Those T‑cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR. ATIR is administered as an adjunctive treatment after a T‑cell depleted haploidentical HSCT facilitating early immune reconstitution without causing life‑threatening (acute) GvHD.
In a Phase I/II study in which high‑risk leukemia patients with very poor prognosis were treated with escalating doses of ATIR after a haploidentical HSCT, long‑ safety, efficacy and proof of concept were confirmed in terms of absence of Grade III/IV (life‑threatening) acute GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival. Positive follow‑up results from this study demonstrating 67% survival after five years and no Transplant Related Mortality in the nine patients who received an efficacious dose of ATIR were recently reported.
An international multi‑centre Phase II study including patients with acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome, to corroborate and extend the safety and efficacy results from the Phase I/II study, is now ongoing with topline data expected in the first half of 2014.
ATIR has been granted Orphan Drug Designation both in the EU and the USA. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.
About Kiadis Pharma
Kiadis Pharma B.V. is a private, clinical stage biopharmaceutical company focused on the development of innovative and potentially life‑saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need.
Kiadis Pharma’s lead product is ATIR, a cell based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors. Kiadis Pharma is collaborating with internationally renowned centers in Europe and North America for the successful development and manufacturing of ATIR. Kiadis Pharma recently obtained a GMP manufacturing license and GMP certificate for its Quality Control laboratory.
Kiadis Pharma is supported by a strong group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, The Netherlands.