Author: Willem van Lawick

~ Significant reduction in Transplant Related Mortality and improvement in Overall Survival observed in comparison to an observational control group ~

~ Zero patients developed grade III-IV acute Graft-versus-Host-Disease upon infusion of ATIR101™ ~

Amsterdam, The Netherlands, December 6, 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 presents positive one-year data with its lead product ATIR101™ from the single dose Phase II trial (NCT01794299/EudraCT 2012-004461-41) at the 58th Annual Meeting and Exposition of the American Society of Hematology (ASH) in San Diego, United States of America.
The data presented at ASH in session 711 by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal, one of the principal investigators for the trial and protocol chair, confirms that ATIR101™ can be safely infused and shows a significant reduction in Transplant Related Mortality (TRM) (primary endpoint) and a significant improvement in Overall Survival (OS) (secondary endpoint) in comparison to an observational control group of patients undergoing a T-cell depleted haploidentical donor transplantation only. Combined with the lack of severe Graft-versus-Host-Disease (GVHD) and limited relapse, this translates into favorable GVHD-free, relapse-free survival (GRFS) one-year post-transplantation. (more…)

– Respiratory Syncytial Virus (RSV), a common contagious lung infection, is a global health threat responsible for up to 200,000 deaths worldwide annually
– UK Phase I trial supported with EUR 3.44 m from Wellcome Trust, taking place at Imperial College, London

Groningen, the Netherlands, November 7, 2016 – Mucosis B.V., a clinical stage biotechnology company using a proprietary technology platform to develop next-generation and needle-free human vaccines for infectious diseases, today announces the start of a first-in-human study of its intranasal Respiratory Syncytial Virus (RSV) vaccine candidate, SynGEM®, at Imperial College London’s Clinical Research Facility.
The first trial will recruit 48 healthy adults (36 vaccinated, 12 placebo) to assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of SynGEM®, in a randomised, double-blind Phase I study. Phase I is completed at day 180 post prime vaccine administration, with interim data readout expected in the first half of 2017. Phase II, due to start mid-2017, will recruit 108 adults (54 vaccinated, 54 placebo). (more…)

Amsterdam, The Netherlands, November 3, 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 that data from the Company’s ongoing Phase II clinical trial (NCT01794299/EudraCT 2012-004461-41) with its lead product ATIR101™ has been selected by the American Society of Hematology (ASH) Program Committee for an oral presentation at the 58th Annual Meeting in San Diego, California on December 5, 2016. (more…)

London. 10 October 2016, 09.00 AM BST. Norgine Ventures announced that it has provided financing of up to €3 million to PulseCath B.V.. This investment recognises the unique positioning of PulseCath’s cardiac assist devices and the growth potential of the company.
PulseCath, based in the Netherlands, develops and commercialises innovative left ventricle assist devices. The lead product, iVAC 2L, is used percutaneously and provides haemodynamic support during cardiogenic shock or high-risk percutaneous coronary interventions. PulseCath devices have a novel design based on pulsatile flow, which is more homogenous with the natural pumping functions of the heart. iVAC 2L is CE-marked and commercialised by Terumo in certain European territories.
The funding from Norgine Ventures will enable PulseCath to accelerate its commercial growth and entry into the US market. (more…)

~ LLS makes second equity investment in Kiadis Pharma for the Phase II development ~

Amsterdam, The Netherlands, July 11, 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 that its partnership with The Leukemia & Lymphoma Society (LLS), the world’s largest voluntary health agency focused on blood cancers, has been strengthened with a second equity investment by LLS into the development of Kiadis Pharma’s lead product ATIR101™.
LLS initially invested approximately US$1 million in February 2016 through an equity investment via its Therapy Acceleration Program (TAP), a strategic initiative to partner directly with biotechnology companies to help accelerate the development of promising therapies. This second investment will now also be used to finance Kiadis Pharma’s second ongoing Phase II trial in leukemia patients which the Company then intends to continue into a randomized controlled Phase III pivotal study on track to start later this year. The ongoing Phase II trial is investigating the repeated dosing of ATIR101™ as an adjunctive treatment to a T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) (donor cells from a half-matched related donor) in adult patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The trial (CR-AIR-008; NCT02500550 / EudraCT 2015-002821-20) is conducted under an IND of the United States Food and Drug Administration and is set up to enroll patients in the United States as well as other countries, including Canada, Belgium, Germany and the United Kingdom.
The second funding by LLS has taken place through an equity investment of approximately US$750,000 and a total of 67,020 shares will be issued to LLS. (more…)