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 its audited annual results for the year ended December 31, 2016, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union.
Operating highlights (including post period end) - Strong progress was made in developing lead product ATIR101™ for blood cancer:
A full annual report for the year ended December 31, 2016 is available on Kiadis Pharma’s website.
Commenting on the annual results, Manfred Rüdiger, CEO of Kiadis Pharma, said:
“We have continued to make good progress with our lead product ATIR101™ during 2016. The statistically significant clinical data from our CR-AIR-007 Phase II trial shows substantially improved benefits on Overall Survival and Graft-versus-Host and Relapse-free Survival (GRFS), which exceeded our expections. We have continued to maintain a close relationship with EMA and based on our Phase II clinical data, our previously obtained ATMP certificate for manufacturing/quality and non-clinical data, as well as our recently accepted Pediatric Investigational Plan, we are now in the final stages of preparing our application dossier for submission to EMA for marketing authorization in Europe. In addition, we have further strengthened the Company and the teams at all levels within the organization. I would like to thank our investors for their support in bringing ATIR101™ closer to patients and my team for their enthusiasm and hard work.”
Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.
On December 5, 2016 at the Annual Meeting of the American Society of Hematology (ASH), the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data showed that ATIR101™ significantly reduced Transplant Related Mortality and significantly improved Overall Survival. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient. Based on these positive results, a Phase III clinical trial has been initiated. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ Phase I/II clinical development has been initiated recently.
Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.com