~ Paves the way for submission of a Marketing Authorization Application for ATIR101™ in Europe ~
Amsterdam, The Netherlands, March 28, 2017, – 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 that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has accepted the Company’s Pediatric Investigation Plan (PIP) for ATIR101™ for the adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for a malignant disease. In addition, the PDCO has agreed that the Company may defer conducting the studies defined in the PIP until after it files a Marketing Authorization Application (MAA) in Europe for the use of ATIR101™ for the treatment of blood cancers.
The Company’s PIP provides for a Phase II trial to evaluate the safety and efficacy of ATIR101™ as an adjunctive treatment on top of an HSCT in pediatric patients up to 18 years of age with a hematologic malignancy, who are eligible for an HSCT but without the availability of a fully matched donor. Patients will receive either an HSCT from a partially matched (haploidentical) related family donor with the adjuvant infusion of ATIR101™, or an HSCT using umbilical cord blood stem cells from an unrelated donor. The primary endpoint of the trial will be Graftversus- Host-Disease-free, relapse-free survival (GRFS).
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “The acceptance of our pediatric development program by EMA’s PDCO is an important regulatory milestone for ATIR101™. Furthermore, the PDCO’s decision to allow us to defer the initiation of our PIP means the Company can submit an MAA to EMA for the use of ATIR101™ in adult blood cancer patients substantially earlier than if it was required to complete the PIP beforehand. This is an important step forward in our efforts to bring ATIR101™ to the market and evidences the close and constructive interactions that Kiadis Pharma has established with the regulatory authorities in developing ATIR101™“.