The Company’s product candidates will provide for “Allodepleted T-cell ImmunotheRapeutics” (ATIR) that are produced with its Theralux technology platform.
ATIR is designed to support the patient’s newly transplanted immune system before it becomes fully functional. In ATIR, T-cells causing Graft-versus-Host-Disease (GVHD) have been depleted, while T-cells protective against tumor cells and infections have been retained. This provides physicians with the opportunity to infuse potent T-cells with minimal risk of causing potential lethal severe GVHD. ATIR therefore addresses one of the biggest challenges of using haploidentical family members as stem cell donors for those patients that would otherwise not find a matching donor in time.
The Company’s lead product,ATIR101, addresses key risks and limitations of HSCT in blood cancers, specifically GVHD and cancer relapse. The Company’s second product, ATIR201, is expected to address the key risks and limitations of HSCT in inherited blood disorders: opportunistic infections, GVHD and limited donor availability.
ATIR101 and ATIR201 are cellular products for infusion. They consist of donor lymphocytes (immune cells), specifically manufactured for each individual patient from a healthy, haploidentical stem cell donor.
Kiadis Pharma’s products have the potential to address significant unmet medical needs for treatment of patients suffering from blood cancers and inherited blood disorders.
Kiadis Pharma's lead product, ATIR101 for blood cancers, has completed enrollment in its ongoing, open-label single dose Phase II clinical trial and 1-year data has been presented at the American Society of Hematology (ASH) in December 2016. ATIR101 will now be studied in a pivotal Phase III trial as an adjunctive immunotherapeutic treatment to a haploidentical HSCT for patients with acute leukemia, with the post transplantation cyclophosphamide approach (the ‘Baltimore protocol’) as control arm.
Clinical development for ATIR201 for thalassemia has recently been initiated in a Phase I/II clinical trial.
ATIR Manufacturing Process
Kiadis Pharma has established a GMP-compliant, manufacturing process that has been successfully transferred to three GMP-manufacturing sites in North America and Europe. The Company is one of seven companies to have ever been issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA).