Kiadis Pharma has received green light from the EMA to start a Phase II trial of its T cell therapy for the treatment of blood cancers in children.
Kiadis Pharma, one of our top biotechs in Amsterdam, is focusing on the development of T cell immunotherapies, which can improve bone marrow transplants used to treat blood cancers and inherited blood disorders. Now, the Pediatric Committee (PDCO) of the EMA has accepted the Company’s Pediatric Investigation Plan (PIP) for its lead product ATIR101. Moreover, Kiadis may file its Marketing Authorization Application (MAA) in Europe for ATIR101 already before initiating the studies defined in the PIP.
ATIR101 is already in Phase III clinical development for the adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for blood cancers in adults. The Company’s PIP consists of a Phase II trial to evaluate the safety and efficacy of ATIR101 on top of HSCT in pediatric patients up to 18 years of age, who are eligible for an HSCT but do not have a fully matched donor.
ATIR101 is a T-cell immunotherapy that eliminates alloreactive cells from the donor to minimize the risk of graft-versus-host disease (GVHD) in HSCT, currently the most effective treatment for most blood cancers. At the same time, ATIR101 contains donor T cells that fight infections and residual tumor cells, thus preventing disease relapse and lowering the risk of infections.
This approach disposes the need of a fully matched donor for the HSCT and requires only a partial donor match, markedly raising the availability of a suitable donor from 35% to 95% of eligible patients.
Kiadis was already able to get an Orphan Drug Designation for ATIR101 both in the US and EU and has recently initiated a Phase III study with ATIR101 in adult patients with acute leukemia — the final step before the company can commercialize the product.
The PDCO’s decision to allow us to defer the initiation of our PIP means the company can submit an MAA to EMA for the use of ATIR101 in adult blood cancer patients substantially earlier than if it was required to complete the PIP beforehand.” commented Manfred Rüdiger, CEO of Kiadis Pharma.
With an expected €9M ($10B) market by 2021, HSCT makes up a major treatment option to fight blood cancer. However, the procedure is associated with significant risks of GVHD and life-threatening infections. Kiadis is tackling a key issue and seems to be having a serious chance of innovating the HSCT market soon.