~ Regulatory strategy update ~
Amsterdam, The Netherlands, June 2, 2016, – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces a regulatory strategy update that, based on positive Phase II data, it has taken the decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead product ATIR101™ for use in blood cancers to reduce relapse rates, Transplant Related Mortality (TRM) and Graft-versus-Host-Disease (GVHD) in the context of a hematopoietic stem cell transplantation using a haploidentical donor. The Company will now start compiling an MAA document and anticipates submitting the application to EMA in Q1, 2017.
An EMA rapporteur and co-rapporteur (who will jointly co-ordinate the evaluation of Kiadis Pharma’s MAA submission) were appointed in early 2015. In addition, in April 2015 Kiadis Pharma received a certificate for its (manufacturing) quality and non-clinical data from EMA.
Positive clinical data from Kiadis Pharma’s single dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) with ATIR101™ was announced on April 4, 2016 at the Annual Meeting of the European Society of Blood and Marrow Transplantation (EBMT) in Valencia, Spain. The data showed that ATIR101™ significantly reduced TRM and significantly improved Overall Survival in comparison to a historical control group of patients that underwent a similar T-cell depleted haploidentical donor transplantation but without the addition of ATIR101™. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient.
Recently, meetings were held with the EMA rapporteur and co-rapporteur during which Kiadis Pharma presented safety and manufacturing data as well as clinical data from this Phase II trial, a trial that was designed on the basis of scientific advice previously given by EMA.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are excited about the progress we have made with ATIR101™ over the past year. The Company is again entering into a new phase in its development as we are starting preparations for commercialization. The submission of an MAA in Q1, 2017 was our ambitious upside-plan communicated at the time of our IPO, now a year ago, and we are moving nicely ahead with good momentum. A launch of ATIR101™ in Europe could be possible as early as 2018 if marketing authorization is granted by EMA. We are also fully committed to starting the enrollment of patients into our planned randomized, international controlled Phase III trial where we will compare the ATIR101™ approach with post-transplant cyclophosphamide (Baltimore approach) in the context of haploidentical transplantation. I look forward to the future with tremendous excitement in this next phase.”