Technology transfer successfully completed and manufacturing underway
Amsterdam, The Netherlands, October 7, 2013 Kiadis Pharma B.V., a biopharmaceutical company developing treatments for blood cancers, announced today that a Services Agreement has been signed with the German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen (GRCBDS) whereby GRCBDS will provide pharmaceutical development and GMP manufacturing services for Kiadis Pharmas ongoing Phase II clinical study with ATIR.
The transfer of the manufacturing process for ATIR has already successfully been completed by GRCBDS at their facility in Frankfurt am Main, Germany and a first batch of Phase II clinical trial material for the European study has now been successfully manufactured.
GRCBDS is one of the largest blood donor services in Europe and has vast expertise and experience in GMP manufacturing blood-derived products for use in daily clinical practice. Furthermore, GRCBDS has experience in manufacturing other cell-based investigational medicinal products which are tested in European clinical studies.
Kiadis Pharma, which has its own GMP manufacturing license, initiated a Phase II international multi-center study with ATIR with up to 23 leukemia patients to corroborate and extend the safety and efficacy results of the previous successful Phase I/II study. Enrollment of patients commenced in Canada in April 2013 and in Europe in August 2013. Topline results are expected in H1 2014.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are pleased to be working with GRCBDS who are now successfully manufacturing the clinical material for our ongoing Phase II trial with ATIR in Europe. GRCBDS experience in the field of cell therapy, combined with their know-how and expertise in Hemato-Oncology, are key reasons to collaborate with them on ATIR’s promising clinical development program.”
Prof. Erhard Seifried, Medical Director of GRCBDS, stated: “We are delighted to enter into this agreement with Kiadis Pharma, an innovator for blood cancer treatment, and to be part of this exciting and highly ethical development of enabling mismatched stem cell transplantations for patients suffering from blood cancer and being in desperate need of a transplant.”
Prof. Halvard Bönig, Head of the Department of Cellular Therapeutics / Cell Processing (GMP) of GRCBDS, added: “Given our extensive experience with technology transfer, process qualification and GMP manufacturing, we feel GRCBDS will be an asset to Kiadis Pharma as it further develops ATIR.”
ATIR 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 do not have a standard of care stem cell donor available. An HSCT is the only potentially curative treatment 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 the HSCT available for all patients worldwide.
Those T-cells in a haploidentical graft which would cause lifethreatening GvHD are selectively eliminated using proprietary technology to produce ATIR. ATIR is administered as an adjunctive treatment after a 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 confirm and extend the data from the Phase I/II study, is now ongoing with topline results of the first phase expected in H1 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.
About Kiadis Pharma
Kiadis Pharma B.V. is a private, clinical stage biopharmaceutical company focused on the development of innovative and potentially life-saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need. Kiadis Pharma’s lead product is ATIR, a cell-based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors. ATIR is currently being studied in an international Phase II study. Kiadis Pharma recently obtained a GMP manufacturing license and GMP certificate for its Quality Control laboratory.
Kiadis Pharma is supported by a strong group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, The Netherlands.