Kiadis Pharma has announced the initiation of Phase III with ATIR101, a T-cell immunotherapy that can improve the outcome of bone marrow transplants.
Kiadis Pharma, one of the hottest biotechs in Amsterdam, is developing immunotherapies for bone marrow transplants in patients with blood cancer. The company has now announced the start of a Phase III trial with its lead candidate, ATIR101. The study, which will recruit 195 patients with acute leukemia, is the final step before the biotech can commercialize its technology.
ATIR101 is a T-cell immunotherapy that eliminates alloreactive cells from the donor to minimize the risk of graft-versus-host disease (GVHD) in hematopoietic stem cell transplants (HSCT), currently the most effective treatment for multiple types of blood cancer.
ATIR101 only requires a partial donor match, raising the availability of HSCT from 65% to 95% of eligible patients in urgent need of a donor. The therapy also eliminates the need for immune suppression and provides the patient with functional T-cells to fight infections and tumor relapse while the transplanted stem cells regrow the immune system, which usually takes from 6 to 12 months.
Kiadis Pharma is already preparing to submit a marketing authorization application (MAA) to the EMA based on the successful results the therapy showed in Phase II trials. If everything goes as expected, Kiadis anticipates that ATIR101 will be launched in Europe in 2018.
The company’s second candidate, ATIR201, recently started a Phase I/II trial in the UK to prevent GVHD in patients with thalassemia that are treated with HSCT.
The main advantage to Kiadis’ unique immunotherapy is that they build on a procedure that has already proven effective when no side-effects arise. By making HSCT safer, the company could soon access a piece of the HSCT market, which is expected to hit €9.5B ($10B) by 2025.
Images from Kiadis Pharma