The Company’s product candidates will provide for “Allodepleted T-cell ImmunotheRapeutics” (ATIR) that are based on its Theralux platform.

ATIR is designed to support the patient’s newly transplanted immune system before it becomes fully functional. 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 is referred to as ATIR101, which addresses the key risks and limitations of HSCT in blood cancers: opportunistic infections, Graft-versus-Host-Disease (GVHD), cancer relapse as well as limited donor availability. 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.

Using the Company’s Theralux platform, those T-cells which can attack the patient, causing GVHD, are eliminated. The full immune repertoire of other donor immune cells, including immunological memory, is retained in the final product.

Kiadis Pharma’s products have the potential to address significant unmet medical needs and make HSCT a first-choice treatment for 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 Phase II clinical trial, and has reached it's primary endpoint and 1-year data has been presented at the American Society of Hematology (ASH) in December 2016. ATIR101 is currently undergoing a Phase II trial to study the safety and efficacy of administering a second dose of ATIR101. A Phase III trial to study ATIR101 as an adjunctive immunotherapeutic treatment to a haploidentical HSCT for patients with acute leukemia has been initiated.

Clinical development for ATIR201 for thalassemia has recently been initiated.

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).

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Product Pipeline

Key Product Claim / Indication
Phase 1 Phase 2 Phase 3
ATIR101

Enabling haploidentical HSCT without severe GVHD for leukemia

ATIR201

Treatment of thalassemia using haploidentical HSCT

Current status      
H1 2017 (expected)