Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD) and relapse. Single dose Phase 2 data with lead product candidate ATIR101 has demonstrated substantial and clinically relevant improvements over historical observational cohort data for a similar HSCT without ATIR101, and also shows an improvement over the Post-Transplant Cyclophosphamide (PTCy), or Baltimore protocol, data reported in scientific literature. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101 across the EU as an adjunctive treatment in HSCT for adult malignant disease. Kiadis Pharma submitted responses to the Day 120 List of Questions in March 2018 and received the Day 180 List of Questions in May 2018, and is on track to obtain a CHMP opinion for ATIR101 in Q4 2018 and, if positive, (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the PTCy/Baltimore protocol). The first patient was enrolled in December 2017.
In September 2017 the U.S. Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the U.S. and Europe.
The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.