Kiadis Pharma BV, a clinical stage biopharmaceutical company developing treatments for blood cancers, has initiated a collaboration to identify and characterize leukaemia-specific T-cells in its lead product ATIR, that would be responsible for the Graft-versus-Leuksemia effect of the T-cell immunotherapy product.

The collaboration will be run with Prof. Dr Angela Krackhardt who leads the group of Translational Immunotherapy at the Department of Hematology (Prof. Christian Peschel) of the Klinikum rechts der Isar of the Technische Universität München.

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.

ATIR 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). ATIR is manufactured from lymphocytes collected from the same donor that provides the graft for the stem cell transplantation of the patient. ATIR is therefore a truly personalized immunotherapy.

Manfred Rüdiger, PhD, chief executive officer of Kiadis Pharma, commented: "We are delighted about our collaboration with the group of Prof. Krackhardt and being part of the Munich m4 Cluster family. We are confident that this will expedite the identification of those T-cells in our lead product candidate, ATIR, that are responsible for the Graft-versus-Leukemia effect of the product. The Cluster's expertise in immunotherapies and the translational work of the University Clinic provide the optimal basis for the success of this collaboration."

Prof. Angela Krackhardt stated: "We are pleased about the joint project with Kiadis Pharma. ATIR provides us with the perfect platform to identify (new) Graft-versus-Leukemia T-cells. The proficiency of Kiadis Pharma and our own well established expertise will result in a unique synergy."

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 leukaemia patients with very poor prognosis were treated with escalating doses of ATIR 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 per cent 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-center phase II study including patients with acute myeloid leukaemia, acute lymphoblastic leukaemia 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.