Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, has announced that its Quality Control (QC) laboratory and the associated Quality system has been inspected for good-manufacturing-practice (GMP) by the Dutch Health Care Inspectorate (IGZ) and has fully met the EU GMP standards. As a result, Kiadis Pharma will receive a GMP manufacturing license and GMP certificate for its QC laboratory from the Dutch Ministry of Health, Welfare and Sport.
GMP licensing and certification enables Kiadis Pharma to perform QC release-assays for the clinical trial manufacturing of the Company’s lead product ATIR(TM), a cellular therapeutic that will enable partially mismatched donor stem cell transplants from family members in blood cancer patients.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This is an important milestone for Kiadis Pharma as we are committed to the highest standards of manufacturing. We are delighted that our QC laboratory and the associated Quality system will receive a GMP manufacturing license and GMP certificate. This not only attests to the quality that we have established at Kiadis Pharma, but secures the pathway to take ATIR(TM) to the next stage of development. ATIR(TM) is currently in an ongoing Phase II study to confirm and extend some exciting data. We expect the Phase II results in H1 2014.”
ATIR(TM) is a cell based medicinal product enabling stem cell transplantations using partially mismatched (haploidentical) family members as donors for patients suffering from blood cancer who lack a suitable standard of care matched donor. Stem cell transplantation is the only potentially curative treatment 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 stem cell transplantations 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 haploidentical stem cell transplantation facilitating early immune reconstitution without causing life-threatening (acute) GvHD.
In a Phase I/II study with ATIR(TM), safety and proof of concept were confirmed in terms of absence of grade III/IV GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival.
ATIR(TM) is currently in Phase II clinical development and has been granted Orphan Drug Designation both in the EU and the USA. In these regions, 20,000 to 25,000 patients a year are unable to find a suitable standard of care matched donor. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.