Date: 2016-06-21
Type of information: Production agreement
Compound: ATIR101™
Company: Kiadis Pharma (The Netherlands) PCT, a Caladrius Company (USA - CA)
Therapeutic area: Technology - Services - Cancer - Oncology
Type agreement: production manufacturing
Action mechanism: cell therapy/immunotherapy product. 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: hematological cancers
Details: * On June 21, 2016, Caladrius Biosciences announced that PCT has expanded its relationship with Kiadis Pharma, by entering into an agreement for the manufacturing of cell therapy product for United States and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101™, for the treatment of blood cancers. To date, PCT has provided engineering and process development services for Kiadis which included optimizing its manufacturing process to incorporate functionally closed processing. Work is currently underway at PCT’s Allendale, New Jersey facility to expand its clean room capacity by 60% and to develop and implement cell therapy specific pharmaceutical grade quality systems. This appointment has been concluded as Kiadis Pharma is preparing its Phase III clinical trial with lead product ATIR101™, on track to be initiated in the second half of 2016.PCT and Kiadis Pharma already closely collaborated on improving and engineering the ATIR101™ manufacturing process for the Company’s Phase III trial. As a result, the technology and processes are already well established at PCT’s Allendale, New Jersey, US facility and PCT will supply study medication to the various Phase III clinical trial sites in the United States and Canada. With regards to the European clinical sites for the Phase III trial, also expected to initiate in the second half of 2016, the Company already has a long-running and successful manufacturing collaboration with the German Red Cross Blood Donor Service , Baden-Wuerttemberg-Hessen, who provided GMP manufacturing services for Kiadis Pharma’s Phase II clinical studies with ATIR101™.
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