Date: 2014-01-29
Type of information: Collaboration agreement
Compound: ATIR™
Company: Kiadis Pharma (The Netherlands) Technische Universität München (Germany)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: collaboration
Action mechanism: ATIR™ is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation 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 stem cell transplantations available for 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 on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.
Disease:
Details: * On January 29, 2014, Kiadis Pharma, a clinical stage biopharmaceutical company developing treatments for blood cancers, announced that it has initiated a collaboration to identify and characterize leukemia-specific T?cells in Kiadis Pharma\'s lead product ATIR™, that would be responsible for the Graft-versus-Leukemia 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 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?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™ 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.
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