~ Prof. Dr.
The project, which has now commenced, was accepted by the Munich Biotech Cluster m4 and receives grant financing from the Cluster for Prof. Krackhardt's group. In the Munich Biotech Cluster, biotechnology companies and academic groups work together under the guiding concept of Personalised Medicine on about thirty research projects, in which new drugs and technologies are developed.
ATIRTM is a T-cell based medicinal product that is currently in international multi-centre Phase II clinical trials as an adjunctive treatment after a T-cell depleted haploidentical stem cell transplantation for patients for whom a matching donor cannot be found (in time). ATIRTM is manufactured from lymphocytes collected from the same donor that provides the graft for the stem cell transplantation of the patient. ATIRTM is therefore a truly personalized immunotherapy.
ATIR(TM) 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(TM) thus has the potential to address this unmet need and to make a 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(TM). ATIR(TM) 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(TM) after a haploidentical HSCT, long-term 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(TM) were recently reported.
An international multi-center 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(TM) has been granted Orphan Drug Designation both in the EU and the
About Kiadis Pharma
Kiadis Pharma's lead product is ATIR(TM), 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
Kiadis Pharma is supported by a strong group of leading international investors including LSP,